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SIG Urogynecology – Overview of Management and Evaluation of Urinary Incontinence (Didactic) PROGRAM CHAIR Neena Agarwala, MD PROGRAM CO-CHAIR Vincent R. Lucente, MD Lawrence L. Lin, MD Charles R. Rardin, MD Robert T. O’Shea, MD Jonathan Y. Song, MD Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME. Table of Contents Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 3 Urinary Incontinence in Women – It Happens to the Best! N. Agarwala ................................................................................................................................................... 4 Evaluation of Urinary Incontinence and Urodynamic Assessment L.L. Lin ......................................................................................................................................................... 13 Non‐Surgical Pharmacologic Treatments of Incontinence – What’s New? J.Y. Song ..................................................................................................................................................... 23 Evolution of Surgical Management of Incontinence R.T. O’Shea .................................................................................................................................................. 29 Does She Have Prolapse? Obliterative or Reconstructive Surgery and Incontinence V.R. Lucente ................................................................................................................................... 36 Occult Stress incontinence – Treat or Not? N. Agarwala ................................................................................................................................................. 51 Fistulae, Diverticulae and Sphincter Urethrae C.R. Rardin ................................................................................................................................................... 55 Refractory OAB – Interstim and Botox Treatment of Urinary Incontinence L.L. Lin ......................................................................................................................................................... 59 Cultural and Linguistics Competency ......................................................................................................... 66 PG 211 SIG Urogynecology – Overview of Management and Evaluation of Urinary Incontinence (Didactic) Neena Agarwala, Chair Vincent R. Lucente, Co-Chair Faculty: Lawrence L. Lin, Robert T. O’Shea, Charles R. Rardin, Jonathan Y. Song This course with include an overview of the evaluation of various types of urinary incontinence with history, exam and office evaluation focus. We shall discuss the diagnostic criteria for stress incontinence, overactive bladder, urge incontinence, mixed incontinence, overflow incontinence and functional incontinence. We shall discuss patient symptoms, voiding diary, office exam and evaluation including simple and complex cystometric evaluation for more complex situations. Management options shall include medication therapy, behavior modification, office treatments, non-surgical options and surgical treatment choices. We shall also discuss the sling procedure, its pros, cons and expectations, tips and tricks and the various modifications, indications and types of slings. Other surgical options will be discussed, including the Interstim treatment, along with its benefits and risks, and Botox treatment. We will cover cystoscopy and its indications as well. Finally, we will discuss a few cases highlighting some uncommon and complex clinical situations like urethral diverticulae, prolapse masking incontinence and neurogenic bladder conditions. Learning Objectives: At the conclusion of this activity, the clinician will be able to: 1) Review the different types of incontinence; 2) discuss the office evaluation along with cystometrics; 3) discuss nonsurgical treatment options with a patient; 4) discuss surgical options, indications and outcomes; 5) evaluate a patient with complex presentation; and 6) use the learning process to understand the complex interaction between prolapse and incontinence. Course Outline 1:30 Welcome, Introductions and Course Overview N. Agarwala 1:35 Urinary Incontinence in Women – It Happens to the Best! N. Agarwala 2:00 Evaluation of Urinary Incontinence and Urodynamic Assessment 2:25 Non-Surgical Pharmacologic Treatments of Incontinence – What’s New? 2:50 Evolution of Surgical Management of Incontinence 3:15 Questions & Answers 3:25 Break 3:40 Does She Have Prolapse? Obliterative or Reconstructive Surgery and Incontinence V.R. Lucente L.L. Lin J.Y. Song R.T. O’Shea All Faculty 1 4:05 Occult Stress Incontinence – Treat or Not? N. Agarwala 4:30 Fistulae, Diverticulae and Sphincter Urethrae 4:55 Refractory OAB – Interstim and Botox Treatment of Urinary Incontinence 5:20 Questions & Answers 5:30 Course Evaluation/Adjourn C.R. Rardin L.L. Lin All Faculty 2 PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Neena Agarwala* Lawrence Lin* Vincent R. Lucente Grants/Research: American Medical Systems, Bard Medical Division, Kimberly-Clark Consultant: Allergan, American Medical Systems, Bard Medical Division, Kimberly-Clark Speakers Bureau: Allergan, American Medical Systems, Bard Medical Division Robert T. O’Shea* Charles R. Rardin* Jonathan Y. Song* Asterisk (*) denotes no financial relationships to disclose. Disclosure I have no financial relationships to disclose. Incontinence: Can happen to the best! Neena Agarwala, MD, MSc Associate Clinical Professor St. Luke’s Roosevelt Hospital Medical Center Columbia University Affiliate New York, NY Epidemiology Urogenital Damage/dysfunction: Neurologic Trauma Hormonal changes Anatomical weakness of the support structures • Pharmacologic • • • • Vaginal delivery ‐Pregnancy and childbirth Aging Estrogen deficiency‐ Hormone effects Neurological disease Non obstetric pelvic trauma and radical surgery Increased intra‐abdominal pressure Drug effects Causes of Incontinence: Aging: Inherited or genetic factors Race Anatomic differences Connective tissue Neurologic abnormalities 4 Gravity Neurologic changes with aging Loss of estrogen Changes in connective tissue crosslinking and reduced elasticity Compounding Problems: Barriers to Treatment Embarrassment leads to silence Time constraints lead to inadequate attention Knowledge limits lead to patient acceptance Technology limits lead to inadequate investigation Resource limits lead to inadequate access • Patient misconceptions and fears: “Part of normal aging or everyday life” “Not severe or frequent enough to treat” “Too embarrassing to discuss” “Treatment won't help” Nothing can be done about it Surgery is the only solution Symptoms: Barriers to Treatment • Healthcare providers – ONLY 30% of patients who seek treatment receive treatment Prevalence of Urinary Incontinence Age (yr.) Female* Male* <30 16 - 52% 6 - 10% 30 - 60 17 - 39% 2 - 12% >60 4.5 - 44% 4.6 - 24% 22 - 90% 22 - 33% Prevalence of incontinence • • • • • • Institutionalized/ Impaired Frequency Nocturia Dysuria Incomplete emptying Incontinence Urgency Recurrent infections Dyspareunia Prolapse • • • *broad prevalence ranges due to variability of UI definition Estimated at 10 - 35% of adults • 50% of institutionalized patients • • Fantl et al. Managing Acute and Chronic Urinary Incontinence. Rockville, MD: Agency for Health Care Policy and Research; 1996. AHCPR Publication No. 96-0686. National Center for Health Statistics. Vital Health Statistics Series 13 (No. 102), 1989. 5 8‐51% in community 10‐25% of women 15‐64 years old At least 50% in nursing homes. 25% suffer from severe incontinence Greatest in older women and increases with age Incontinence 6‐10x greater in women than in men By 2040 22% of female population will be>65 As the proportion of PMP women increases over the next 30 years, these conditions will become even more prevalent. A woman's lifetime risk of surgery for prolapse or urinary incontinence is 11.1% by the age of 80. Affects at least 13 million Americans of all ages 85% are women Recent Gallup survey indicates that ~70% of these women have symptoms of stress incontinence Statistics: Statistics: 10‐25% of women age 15‐64 report urinary incontinence 15‐40% of women over age 60 in the community report incontinence More than 50% of women in nursing homes are incontinent W.H.O. recognizes incontinence as an international health concern 10‐60% of women report urinary incontinence 50% of women that have had children develop prolapse Only 10‐20% seek medical care Billions of dollars spent annually on incontinence products (in North America) Estimated Economic Costs of Overactive Bladder in the US in Year 2000 Cost of Urinary Incontinence 1994 - Direct Costs1 Community Institutional $13.8 billion $4.4 billion - $11.2 billion/year in the community - $5.2 billion/year in nursing homes 60% greater than the 1990 estimate2 Does not count urgency/frequency alone 1995 - Total Societal Costs3 - individuals +65 - $26.3 billion/year - per person cost - $3,565 /year ( 174% from 1884) Total economic costs $18.2 billion 1. Hu. National Multi-Specialty Nursing Conference on Urinary Incontinence, 1994. 2. Hu. J Am Geriatr Soc. 1990;38:292-295. 3. Wagner. Urology. 1998;51(3):355-361 Hu T et al. WHO/ICI 2001. Abstract. Costs of Urinary Incontinence Frequency of Selected Chronic Conditions in the United States Total Cost in 1995 > $26 Billion U.S. Overactive Bladder? $3,600 annually per person aged 65 years Incontinence consequence costs 50% Routine costs 43% Indirect costs 3% Diagnostic costs 1% Treatment costs 3% Millions † Source: Wagner TH, Hu TW. Urology. 1998;51:355-361. 6 Stewart, W., et al. World J Urol. In press. Pleis, JR and R Coles. Summary Health Statistics for U.S. Adults: National Health Interview Survey, 1998. National Center for Health Statistics. Vital Health Stat. 2002:10(209). Impact of Overactive Bladder on Quality of Life Compared to Other Conditions 90 Quality of Life Impact: 80 Normal Impact on lifestyle and avoidance of activities Fear of losing bladder control Embarrassment Impact on relationships Increased dependence on caregivers Discomfort and skin irritation 70 Hypertension Diabetes 60 Overactive bladder Depression 50 40 0 Emotional Physical Vitality Bodily Limitations Pain Functioning Physical Mental General Social Limitations Health Health Function Kobelt-Nguyen et al. 27th annual meeting of ICS, 1997. Medical Sequelae of Incontinence New and revised terms are relatively vague to allow for patient‐to‐patient variability Increased risk of slips and falls Prevalence: 20-40% with 90% causing fx, in women over 65 • Overactive bladder is a syndrome of symptoms that suggest dysfunction of the lower urinary tract. It is characterized by urgency with or without urge incontinence, usually involving frequency and nocturia. • Urinary incontinence is any involuntary leakage of urine. • Daytime frequency. The patient feels she voids more frequently than she should during the day. • Nocturia. The patient wakes 1 or more times at night to void. • Urgency. The patient feels a sudden, compelling desire to pass urine. Incontinence, significant risk factor for hip fracture Infection, local or systemic Skin irritation or breakdown Dehydration Innervation of the LUT Types of Urinary Incontinence: Inferior mesenteric ganglion Sympathetic: relaxes Trigone Genuine stress incontinence Urge incontinence Mixed Chronic urinary retention and overflow incontinence Functional incontinence Miscellaneous (UTI, dementia) Total incontinence Urethra Parasympathetic: contracts T10-L2 Somatic S2-S4 Adapted from Abrams P, Wein AJ. The Overactive Bladder: A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998. 7 External urethral sphincter Muscles of the pelvic floor Neurologic control in voiding Types of Urinary Incontinence • Normal mechanism is a cortical control of voiding reflexes mediated by pontine micturation center and sacral cord • It suppresses bladder contractions until conscious desire to void • Upper motor neuron lesion – overactivity • Lower motor neuron lesion – underactivity Heart = Tachycardia Gall Bladder Stomach = Dyspepsia Colon = Constipation Bladder (detrusor muscle) Adapted from Abrams P, Wein AJ. The Overactive Bladder: A Widespread and Treatable Condition. Erik Sparre Medical AB; 1998. Muscarinic Receptors Brain Glands Heart M2 M3 M4 M5 X X X X X X X X GI Bladder Loss of urine with increases in abdominal pressure Caused by pelvic floor damage/weakness or weak sphincter(s) Symptoms include loss of urine with cough, laugh, sneeze, running, lifting, walking X X X X Sudden increase in intra-abdominal pressure Uninhibited detrusor contractions Urethral pressure Genuine Stress Incontinence: M1 Eyes Stress urine loss resulting from sudden increased intra-abdominal pressure (eg, laugh, cough,sneeze) – combination of stress and urge incontinence • Urge incontinence is caused by overactivity of the bladder muscle. • This overactivity may be caused by an irritation of the bladder, emotional stress, or medical conditions such as Parkinson's disease or a stroke. • Micturation reflex ‐> Salivary Glands = Dry Mouth Muscarinic receptors are also located in the CNS. • Mixed symptoms Factors causing incontinence Iris/Ciliary Body = Blurred Vision Lacrimal Gland = Dry Eyes • Dizziness • Somnolence • Impaired Memory & Cognition Urge urine loss accompanied by urgency resulting from abnormal bladder contractions Distribution of Muscarinic Receptors Parasympathetic Nervous System CNS X 8 Urge Incontinence: Overactive Bladder Loss of urine due to an involuntary bladder spasm (contraction) Complaints of urgency, frequency, inability to reach the toilet in time, up a lot at night to use the toilet Multiple triggers • Overall prevalence of OAB is estimated at 16.6% • Prevalence of OAB is almost equal in women and men (16.9% vs 16.2%, respectively) and increases with age • OAB affects approximately 33.3 million adults in the US, nearly 24 million of whom are older than 45 years • OAB significantly impairs HRQoL, even in those without urge incontinence NOBLE: Prevalence of OAB in the US Characteristic Symptoms of OAB 16.6% of the adult population (age 18 years) OAB Bladder pressure greater than urethral pressure • Can be dry or wet • Frequency and • Urgency • Urge incontinence 33.3 million adults US population = 200 million adults* *Estimate based on 2000 US census Adapted from Stewart W et al. WHO/ICI 2001. Poster. OAB Symptoms Symptoms Frequency • Symptoms of urge incontinence include the need to urinate frequently and a sudden, urgent need to urinate. • 8 or more visits to the toilet per 24 hours Urination at night • 2 or more visits to toilet during sleeping hours Urgency Urge Incontinence • Sudden, strong desire to urinate • Sudden & involuntary loss of urine OAB 9 Addressing Transient Conditions That Mimic OAB Economic & Social Costs • Easily reversible conditions • Number one indication for admission to an assisted or extended care living • This is an underserved patient population • Extended care facilities welcome the help – urinary tract infection • Associated conditions – urogenital aging – bladder outlet obstruction – prolapse – stress incontinence – voiding difficulties Mixed Incontinence: Chronic Urinary Retention: Outlet obstruction or bladder underactivity May be related to previous surgery, aging, development of bad bladder habits, or neurologic disorders Medication, such as antidepressants May present with symptoms of stress or urge incontinence, continuous leakage, or urinary tract infection Combination of stress and urge incontinence Common presentation of mixed symptoms Urodynamics necessary to confirm Functional and Transient Incontinence: Unusual Causes of Urinary Incontinence: Mostly in the elderly Urinary tract infection Restricted mobility Severe constipation Medication ‐ diuretics, antipsychotics Psychological/cognitive deficiency Urethral diverticulum Genitourinary fistula Congenital abnormalities (bladder extrophy, ectopic ureter) Detrusor hyperreflexia with impaired contractility 10 Potential Etiologic Factors for SUI Factors causing incontinence • Stress incontinence is caused by descent of bladder and or urethra • Anatomic factors following childbirth • Thinning of the pelvic floor musculature • Decreased collagen synthesis in urethra • Previous pelvic surgery • Smoking, chronic constipation • Aging, estrogen deficiency – – • Elasticity, vascularity and thickness of urethra depends on estrogen status – Menopause • Urethral function needs adequate reflex muscular contractions in stress, but pelvic floor denervation may destroy it – Age – Childbirth Hormone Effects: Pregnancy and Childbirth: Common embryonic origin of bladder urethra and vagina from urogenital sinus High concentration of estrogen receptors in tissues of pelvic support General collagen deficiency state in postmenopausal women due to the lack of estrogen (Falconer et al., 1994) Urethral coaptation affected by loss of estrogen Hormonal effects in pregnancy Pressure of uterus and contents Denervation (stretch or crush injury to pudendal nerve) Connective tissue changes or injury (fascia) Mechanical disruption of muscles and sphincters Resources Resources • Chapple • Churchill, Livingston 2000 • Ostergard • Lippincott 2003 – – – – – Age Childbirth – “This book aims to dispel the image that urodynamics is a complex subject.” New Well written Comprehensive Terminology changes Internet section 11 Resources Resources Walters, Karram Mosby, 1998 • • • • • Payne CK. Campbell’s Urology Updates. 1999;1:1-20. Evans DA et al. Milbank Q. 1990;68:267-289. Bureau of the Census, Population Estimate Data, 1995. National Institutes of Health. Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis Overview. National Center for Health Statistics. Vital Health Stat. 10(199):1998. 12 www.augs.org (urogyn society) www.continet.org (ICS) www.ichelp.org (interstitial cystitis) www.suna.org (nurses, CNP) www.reiters.com (Reiter’s Books) Disclosure I have no financial relationships to disclose. Evaluation of Urinary Incontinence and Urodynamic Assessment Lawrence Lin MD Thousand Oaks, CA History and Physical Exam The main objectives: • Develop a better understanding of multi‐channel urodynamic studies • Focus on clinical “Case Scenarios” of abnormal urodynamic studies. 3 most common types incontinence & voiding dysfunction. (1) Stress incontinence (2) Overactive bladder Mixed incontinence (3) Incomplete bladder emptying. History and Physical Exam History and Physical Exam For stress incontinence: • Leak with cough, laugh, sneeze • Leak with exercise • Leak with walking, bending over, lifting things • How often do you leak? (Severity of leakage) For overactive bladder • Worsening urgency • Worsening frequency • Nocturia (x > 2 abnormal) • Urge incontinence. • Leak before you reach the toilet ‐ Once per day ‐ Couple of times per week ‐ Couple of times per month ‐ Once every few month • Do you wear a pad? Thin or thick pad? 13 History and Physical Exam History and Physical Exam Differential Diagnosis: For incomplete bladder emptying • How many times ‐void daytime (x > 8 abnl) • How many times‐ void at night (x > 2 abnl) • Often needs to void for 2nd or 3rd time after initial void • Hard to begin urinating • Slow urinary stream • Strain to void. Needs to lean forward to void. Needs to push on bladder to void. Need to rule out other medical and neurological conditions such as: • Diabetes • Stroke • Back injury or Lumbar disc disease • COPD / Chronic cough • Chronic constipation voiding dysfunction • Previous prolapse surgery or vaginal surgery • Previous incontinence surgery • Radiation to pelvis • Medication voiding dysfunction History and Physical Exam History and Physical Exam Physical Exam: • Hypermobile urethra with Q‐tip change x > 30 degrees • R/O vaginal atrophy vs OAB • R/O vaginal discharge • R/O prolapse ‐‐ > incomplete bladder emptying Neurologic Exam: • Evaluate mental status dementia etc • Evaluate sensory function of the lower extremities • Evaluate motor function of the lower extremities e.g. Parkinksons, Multiple sclerosis, Cerebrovascular Disease etc. Work Up • • • • Work Up 24 hr bladder diary R/O UTI. Check UA and culture R/O emptying: Void and post void residual Pad tests Normal Values: • Normal bladder capacity is 400‐500 cc. • Normal voiding: a. Should empty 80‐90% of total bladder capacity b. Or PVR x < 100 cc. ‐Simple pad test: Count the number of pads changed per day ‐1 hour pad test: Weigh the pad after 1 hr (after drinking 500 ml) ‐24 hr pad test 14 Office Diagnostic Tests Office Diagnostic Tests Two office tests (1) Simple CMG (Cystometrogram) (2) Multi‐channel urodynamic testing Simple CMG (Cystometrogram) single channel catheter From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Office Diagnostic Tests Multichannel urodynamic studies (UDS) Simple CMG (Cystometrogram)—single channel (1) First, check void volume and PVR. (2) Bladder is filled with sterile water using a 50 cc Toomey syringe (3) Measure 1st sensation and maximum bladder capacity (4) (+) DI if there is a change in the water level (5) Cough test at 200, 300, and 400 cc. 1. Is UDS indicated for straight forward SUI? Ans: Not indicated by the AUA guidelines. 2. What are the indications for UDS? Ans: (a) SUI without urethral hypermobility (b) Mixed incontinence (c) Failed incontinence surgery (d) Failed OAB / urge incontinence surgery Multichannel Urodynamic Studies. UROFLOW Office Diagnostic Tests Uroflow: amount urine voided over time X‐axis: Time (in seconds) Y‐axis: Flow rate (ml/sec) Multichannel Urodynamic Studies—4 main parts 1) Uroflow 2) Complex CMG (Cystometrogram) 3) Urethral Pressure Profile (UPP) 4) Pressure Flow Study (PFS) Normal Uroflow curve should look like a normal bell shaped curve Normal values: • NL flow: if pt voids at least 200 ml over 15‐20 sec • Normal: “Max flow rate:” x > 20 ml/sec. Average Flow rate 10 ml/s • Abnormal: “Max flow rate:” x < 15 ml/sec Average Flow rate x < 5 ml/sec From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. 15 Multichannel Urodynamic Studies: UROFLOW Multichannel Urodynamic Studies: UROFLOW What is the role of uroflow? Maximum Flow Rate Ans: To evaluate voiding dysfunction or bladder emptying problems. Median flow rate From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Multichannel Urodynamic Studies: UROFLOW Multichannel Urodynamic Studies: UROFLOW I. Normal uroflow pattern: Bell shaped curve Advantage of the uroflow is that it is a noninvasive test to document voiding function and dysfunction. It is considered a good screening test. II. Abnormal uroflow pattern. a. Superflow pattern—suggestive of ISD (poor urethral resistance) b. Obstructive voiding patterns i. Abnormal detrusor contractility (e.g. Incomplete bladder emptying / Neurogenic bladder) ii. Urethral obstruction / resistence iii. Both above (e.g DSD—detrusor sphincter dyssynergia) Disadvantage: It does not provide direct information about detrusor pressures or outlet resistence. Case scenario # 1 ISD. Intrinsic sphincter deficiency. Multichannel Urodynamic Studies: UROFLOW Case scenario # 1 Intrinsic sphincter deficiency (ISD) Normal void takes 15‐20 second to void 200 ml. In this case, the patient voids 400 cc in 5‐ 10 seconds. Time (seconds) From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery Missouri 1999 Mosby 16 Incomplete bladder emptying: (1) Voided 150 cc. PVR 900 cc. (2) Maximum flow rate 18 ml/sec. Flow time 16 seconds. (3) Now starting to develop recurrent UTIs. Case scenario # 2 Incomplete bladder emptying NORMAL VALUES: PVR < 100 cc or Empty 80‐90% of total bladder volume. 53 y/o with a history of incomplete bladder emptying x 10 years that is getting progressively worse. During the daytime, she voids every 1 hr. Nocturia 4‐5 x per night. Normal Flow Rate Incomplete (ml/s) emptying Volume (cc) Normal Incomplete emptying Multichannel Urodynamic Studies: UROFLOW Incomplete bladder emptying Another example: Void 450. PVR 200 Case Scenario # 3: (2) Outlet obstruction. (Ex. TVT sling too tight) Sinusoidal pattern. Flow rate based on Valsalva alone. The moment you stop Valsalva, you have no flow. The wave like pattern represents contraction of the abdominal muscle or contraction of the external urethral sphincter. Flow rate (ml/s) Vol voided (ml) C Multichannel Urodynamic Studies: UROFLOW Case Scenario # 2: Case Scenario # 3: (2) Outlet obstruction. (Ex. TVT sling too tight) Outlet Obstruction (ex. Sling too tight) Case Scenario # 4: (3) Outlet obstruction. (Ex. Enlarged prostate) Prolonged bell shaped curve. Prolonged voiding times. Instead of voiding in 15‐20 seconds, pt voids over a time period of 1‐5 minutes. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. 17 Multichannel Urodynamic Studies: UROFLOW C Case Scenario # 2: Case Scenario # 4: (2) Outlet obstruction. (Ex. TVT sling too tight) Outlet Obstruction (Ex. Enlarged prostate) Abnormal slow flow rate over prolonged time Case Scenario # 5 (4) MVA. Neurologic lesion, classically high spinal cord trauma. Detrusor sphincter dyssynergia (DSD). This is a condition where there is a lack of coordination between the detrusor muscle and the external striated urethral sphincter muscle. Flow Rate (ml/sec) cology and 1999, Mosby. Time (sec) From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Multichannel Urodynamic Studies: Complex CMG (Cystometrogram) C Case Scenario # 2: Case Scenario # 5: (2) Outlet obstruction. (Ex. TVT sling too tight) Detrusor Sphincter Dyssynergia (Intermittent multi‐peaked pattern) Flow Rate (ml/sec) Time (sec) From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Complex CMG P ves: Pressure in bladder P abd: Pressure in vagina Pdet: Pves – P abd 4 Case Scenarios DETRURSOR PRESSURE: A: Normal bladder pressure. During normal bladder filling, the bladder pressure is low (P det < 40 cm H20) P ves P abd P det B. Overactive bladder. Increased detrusor overactivity. Bladder contractions with a return to baseline. C: Phasic contractions with a gradual rise in true detrusor pressure Fill Volume (ml) D: Low compliance bladder. Steady rise in detrusor pressure From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. 18 Multichannel Urodynamic Studies: Complex CMG Multichannel Urodynamic Studies: Complex CMG Results from Complex CMG 1. SUI and the severity of the SUI. 2. Intrinsic Sphincter Deficiency (ISD) 3. Overactive bladder 4. Mixed incontinence 5. Small bladder capacity 6. Detrusor areflexia (aka bladder acontractility) 7. Poor Bladder Compliance. Advantage of the Complex CMG is that it provides information on detrusor pressure and the abdominal pressure. Disadvantage of Complex CMG is that this is an invasive test, and 20‐30% of patients are not able to void around the catheter. Case Scenario # 1: Stress urinary incontinence (SUI) Multichannel Urodynamic Studies: Complex CMG Case Scenario # 1: Stress urinary incontinence (SUI) Patient leaks with coughing, laughing, sneezing, and any type of physical activity. Failed Kegel exercises. P ves P abd P det Intrinsic Sphincter Deficiency Clincally, UDS shows that she leaks copious amounts, like a faucet. VLPP = 20 cm H20 Multichannel Urodynamic Studies: Complex CMG Case Scenario # 2: Instrinsic Sphincter Deficiency (ISD) 52 y/o female that complains that she leaks multiple times a day. Wears a heavy duty pad and she changes this pad multiple times per day. Leaks even with walking or bending over. Cough stresstest in the office shows copious amounts. Valsalva leak point pressure (VLPP < 60 cm H20) P ves P abd P det Fill Vol (ml) 19 Multichannel Urodynamic Studies: Complex CMG (+) Detrusor overactivity: At 160 cc, she leaks ½ of her total bladder volume At 320 cc, leaks another ½ of her total bladder volume Case Scenario # 3: Overactive bladder (aka Detrusor overactivity) Pt is a 79 y/o female with complete procidentia and worsening bladder urgency and frequency. complains of bladder urgency, frequency, and nocturia. Also (+) urge incontinence. Leaks when she hears running water and leaks just watching TV. P ves P abd P det Complex CMG Case Scenario # 4: Mixed incontinence. Case Scenario # 5: Small bladder capacity (Sensory urgency): Pt voids every 1 hour during the daytime. Nocturia 3‐4 x per night. Never gets a good nights sleep. Uroflow shows a total void volume of 100 cc and she states that was very full. Bladder study shows no DO. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. P abd P ves P det From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Multichannel Urodynamic Studies: Urethral Pressure Profile (UPP) Complex CMG Case Scenario # 6. Neurogenic bladder (Hyposensitive bladder). Pressure‐Flow Studies (Complex CMG) Case Scenario # 6.: Small bladder capacity (Sensory urgency): Pt voids every 1 hour Pt complains that she has overflow incontinence. She has no during the daytime. Nocturia 3‐4 x per night. Never gets a good nights sleep. Uroflow sensation that her bladder is full. She has no urge to void. She shows a total void volume of 100 cc and she states that was very full. Bladder study needs to void on a set schedule every 2‐3 hours otherwise she has shows no DO. . • Normal female urethra is approx 4 cm in length • UPP test—main function is to diagnosis Instrinsic Sphinter Deficiency (ISD) • Normal urethral closure pressure (Uclo x > 20 cm H20) • Abnormal urethral closure pressure (Uclo x < 20 cm H20) leakage. History of recurrent UTIs. History of Multiple Sclerosis. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. 20 Multichannel Urodynamic Studies: Urethral Pressure Profile (UPP) A: Both transducers start inside the bladder. B: As the catheter is mechanically withdrawn through the urethra, the urethral and bladder pressures are recorded. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Multichannel Urodynamic Studies: Urethral Pressure Profile (UPP) Column A: Continent patient. Urethral pressures >> Bladder pressures. No pt has no leakage. Intrinsic Sphincter Deficiency (ISD) a. Uclo pressure < 20 cm H20 b. Valsalva Leak Point Pressure x < 60 cm H20 c. Clinically, she leaks with walking or any type of simple activity. d. UDS: Leaks copious amounts, like a faucet with cough or Valsalva. Column A Column B Column B: Incontinent patient. Uclo < 20 cm H2O. Urethral pressures << Bladder pressure. (+) urinary incontinence From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Pressure‐Flow Study Pressure‐Flow Study Normal pressure flow study : Pt voids with urethral relaxation and bladder contraction. Two phases: (1) Filling phase: Phase I: slight rise in bladder pressure. Phase II: Bladder accommodation. Phase III: (2) Voiding phase: At maximum bladder capacity. Phase IV: (+) detrusor contraction and then pt voids. Indications for Pressure Flow Study? Ans: To distinguish between obstructed flow versus hypocontractile / acontractile flow. Examples: • Urinary retention 1 month after bladder botox • Sling too tight with slow stream • DSD (Detrusor sphincter dyssynergia) From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. 21 Pressure‐Flow Study Case: Normal filling and voiding. No SUI. No overactive bladder. At max capacity, detrusor contraction leads to drop in urethral closure pressure, and voiding initiated. Pressure Flow Study Case Scenario : Post‐op obstruction from recent TVT sling Pre‐op UDS shows pt voided normally with low post void residual. After her sling procedure, she now complains that she needs to empty for a second or a third time after her initial void. PFS show high detrusor pressure with a low flow rate. P abd P ves P det From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Post‐op obstruction from recent TVT sling High bladder pressure. High detrusor pressure. Low flow rate. High post void residual. Pressure‐Flow Study Acontractile bladder: Pt voids by Valsalva maneuver only. Absent bladder contractions. P ves P abd Clinically, pt needs to bend over or push suprapubically on her bladder in order to better empty her bladder. P det Flow rate (ml/s) Vol voided (ml) Normal flow rate Abnormal flow rate From Walters MD, Karram MM: Urogynecology and Reconstructive Pelvic Surgery, Missouri, 1999, Mosby. Case scenario Previous TOT sling 1 week ago with voiding dysfunction and difficulty emptying bladder. (1) Do you need to repeat another UDS? (2) How long do you wait before you decide to take the patient back to the OR to loosen the sling? (3) Do you loosen the sling or do you cut the sling? (4) How do you loose the sling? Thank you 22 Non-Surgical Pharmacologic Treatments of Incontinence – What’s New? Disclosures Jonathan Y. Song, MD, FACOG, FACS TLC Medical Group, S.C. I have no financial relationships to disclose. Medical Director Robotics and Minimally Invasive Surgery Presence Mercy Medical Center Medical Director Robotics and Minimally Invasive Surgery Cadence Health - Delnor Hospital Assistant Professor Department of Obstetrics and Gynecology Rush University Medical Center Objectives Urinary Incontinence After completing this course the participant will be able to: Differentiate the types of pessaries available to treat incontinence Distinguish pharmacologic agents used to treat incontinence by drug class Choose the appropriate first-line medication to use for uncomplicated urge incontinence 1. Swift SE. Epidemiology of Pelvic Organ Prolapse and Urinary Incontinence. Ostergard’s Urogynecology; 2008: 27-38 Urinary Incontinence Stress Incontinence (50%) Involuntary leakage of urine with effort or exertion or valsalva Leakage of urine with abdominal contraction in absence of detrusor contraction Urethral dysfunction; urethrovesical hypermobility Can be caused by Intrinsic Sphincter Deficiency Estimated between 23% to 35% of adult women Prevalence increases with age until 50 where it plateaus Difficult to obtain specific percentages of different types of incontinence Pessaries Urge Incontinence (25%) Interchangeably termed with Overactive Bladder Sudden compelling desire to urinate that is difficult to defer Idiopathic/Myogenic/Neurogenic Mixed Incontinence (25%) May manifest as both emptying and storage abnormalities Involves neuropathic conditions due to: trauma/inflammation/Infection/De generation 2. Abrams P, Cardozo L, Fall M, et al Urology 2003;61:37-49 3. Cucchi A, Siracusano S, Guarnaschelli C, et al Neurourol Urodyn 2003;22:223-226. 23 Made of medical-grade silicone Very durable Low likelihood of foulsmelling vaginal discharge Pessaries for Incontinence Pessaries for Incontinence Ring with Support Gellhorn Resembles a large diaphragm Effective and comfortable for patients Works well for almost all types of defects Easier for patients to insert and withdraw 4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860. 6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462. 4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860. 6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462. Pessaries for Incontinence Pessaries for Incontinence Doughnut Resembles a mushroom Effective and comfortable Should be used as secondline pessary when initial one fails Creates more friction and suction May be more difficult for patients to insert/remove Gehrung (w/wo Knob) Space-filling Can be useful and effective Difficult to insert and remove Produces most amount of vaginal discharge and odor 4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860. 6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462. Manually molded to fit almost any type and size of prolapse present 9 different sizes in all Can correct vaginal vault prolapse Can be technically challenging for some paients Not commonly used 4. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860. 6. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. Ostergard’s Urogynecology; 2008: 454-462. Nervous System Pessaries for Incontinence Central Nervous System (CNS) Bladder Neck Supporter5 (Introl) Provides enhanced angle to the bladder neck Supports urethrovesical junction Difficult to insert and remove for the patient Brain Spinal Cord Peripheral Nervous System (PNS) Afferent Division Efferent Division Somatic System (voluntary) Autonomic System (involuntary) Sympathetic Parasympathetic 5. Pott-Grinstein E, Newcomber JR. Gynecologists’ pattern of prescribing pessaries. J Reprod Med 2001;46:205-208. 24 Alpha and Beta Receptors Epinephrine/Norepinephrine Muscarinic/Cholinergic Receptors Acetylcholine Pathophysiology of Urinary Incontinence Bladder Physiology Storage and Voiding Bladder fills when sympathetics cause Detrusor relaxation with closed internal sphincter with inhibition of parasympathetics Bladder empties when parasympathetics cause Detrusor contraction, overides sympathetic control of internal sphincter, somatic opens external sphincter Micturition reflex triggered when pressure exceeds 20-40 cm H2O Malfunction at any level - bladder, urethra, sphincter, CNS, PNS Disturbances in filling/emptying may lead to urge and stress incontinence Interruption with emptying can cause urinary retention and overflow incontinence Various CNS abnormalities leading to derangements in inhibitory pathways can cause detrusor instability 8. Wein A. Neuromuscular dysfunction of the lower urinary tract and its treatment. Campbell’s Urology. 2002 7. DeMaagd G, Geibig J. Pharm Thera 2006:31(8): 462-474. Nervous System Categories of Incontinence Medications Antimuscarinics Tolterodine Trospium Darifenacin Solifenacin Central Nervous System (CNS) Adrenergic agonists Ephedrine Phenylpropanolamine Imipramine Brain Spinal Cord Peripheral Nervous System (PNS) Afferent Division Efferent Division Agents with multiple actions Oxybutynin Propiverine Dicyclomine HCL Flavoxate HCL Miscellaneous Somatic System (voluntary) Autonomic System (involuntary) Tricyclic antidepressants Botulinum Toxin Capsaicin (not available in the US) RTX (not available in the US) Sympathetic Parasympathetic Muscarinic/Cholinergic Receptors Acetylcholine Peripheral Nervous System Blocking Parasympathetic System Alpha and Beta Receptors Epinephrine/Norepinephrine At least 5 muscarinic receptor subtypes exist (M1-5) M1, M2, M3 identified to be present on bladder For antimuscarinic meds, tissue selectivity has greater impact than subtype selectivity in minimizing side effects β1, β2 and β3 receptors are found in smooth muscle of bladder 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 10. Lippincott’s Pharmacology 5th Ed 2011 25 Receptor Types with Effects of Anticholinergic Blockage Antimuscarinic Agents Organ System Receptors Salivary Glands M1, M2, M3 Dry mouth Cardiac Tissue M2 Tachycardia, Palpitations Eye (ciliary muscle, iris) M3, M5 Dry eyes, Blurred vision GI Tract M1, M2, M3 Prolonged transit time (constipation), Gastric acid secretion Effects on memory, Confusion, Hallucinations, Sleep disturbance, Retarded psychomotor speed CNS (cortex and hippocampus) Bladder (detrusor muscle) M1, M2, M3, M4, M5 M1, M2, M3 Effects of Blockage Current Historic Atropine Sulfate Emepronium Bromide Scopolamine Tolterodine Trospium Darifenacin Solifenacin Decreased contraction, Urinary retention 7. DeMaagd G, Geibig J. Pharm Thera 2006:31(8): 462-474. 24. Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004;3:46–53. 25. Gormley EA, Lightner DJ, Burgio KL, et al. Urol. 2012;188:2455-2463. Antimuscarinic Agents Tolterodine Antimuscarinic Agents Trospium Tertiary amine Non-specific competitive M-receptor blocker First antimuscarinic agent specifically targeted to combat bladder overactivity Multiple randomized clinical trials available Decreases number of micturition per 24 hrs, incontinence episodes, frequency and urgency symptoms, increase void volume Available as immediate-release (1-2 mg bid) and extended (2 mg or 4 mg q day) 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 11. Madersbacher H, Stohrer M, Richter R, et al. Trospium chloride versus oxybutynin: a randomized, double-blind, multicentre trial in the treatment of detrusor hyper-reflexia. Br J Urol. 1995;75:452-456. 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 Antimuscarinic Agents Darifenacin Quaternary amine Atropine-like non-selective M-receptor blocker (M1-5) Over 20 clinical trials documenting improving detrusor instability and hyperreflexia Low incidence of side effects Poor bioavailability (must be taken on empty stomach) Appears to be tissue specific Immediare release (20 mg bid) or extended (60 mg q am) Antimuscarinic Agents Solifenacin Highly selective M3 receptor blocker Selectivity allows for less adverse side effects Once a day dosing (7.5 mg or 15 mg) Significant reduction in urinary incontinence, frequency and urge Causes less dry-mouth symptoms than Oxybutynin 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 12. Newgreen DT, Anderson DP, Carter AJ. Neurourol Urodyn 1995;14:95 13. Ebinger U. Poster 4029. Abstract in the 17th World Conference of Family Doctors, 2004 Great tissue selectivity for the bladder First antimuscarinic statistically significant showing reductions in urgency episodes per 24 hours in multiple trials Once a day dosing (5 mg or 10 mg ) 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 14. Hatanaka T, Ukai M, Ohtake A, etal. International Continence Society Meeting, 2003 15. Lucente V, Swift S. AUGS/SGS Joint Scientific Meeting Abstracts, 2004 26 Agents with Multiple Actions Oxybutynin Agents with Multiple Actions Oxybutynin Propiverine Dicyclomine Flavoxate Tertiary amine with anticholinergic antagonism, myotrophic relaxation, local anesthesia Used as the gold standard for overactive bladder for more than 30 years Possesses some degree of selectivity for M1 and M3 receptors Immediate release has short half-life (2.5 to 5 mg bid-tid) Extended release (5, 10, 15 mg once a day) Transdermal patch (1 patch twice/week) avoids first-pass Topical ointment and gel 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 16. Thuroff JW, Chartier-Kastler E, Corcus J, et al. World J Urol 1998;16(suppl 1):s48 Agents with Multiple Actions Propiverine Agents with Multiple Actions Dicyclomine Tertiary amine Predominantly with anticholinergic activities Secondary effects on myotropic relaxation Nine randomized controlled trials available Studies included patients with detrusor instability and hyperreflexive detrusor function Not currently available in the U.S. Tertiary amine Posseses both anticholinergic and relaxant effects on smooth muscle Only few randomized trials available Several studies demonstrated favorable results in detrusor activity Used more often to treat Irritable Bowel Syndrome due to relaxation effects on smooth muscle as anti-spasmotic 20-40 mg po qid 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 17. Halaska M, Dorschner W, Frank M. Neurourol Urodyn. 1994;13:428-430. 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 18. Castleden CM, Duffin HM, Millar AW. Clin Exp Gerontol. 1987;9:265-270. Agents with Multiple Actions Flavoxate Adrenergic agonists Tertiary amine Myotropic relaxant Weak anticholinergic effect Many studies showed limited effect on detrusor activity International Continence Society does not recommend common usage due to lack of encouraging data 100-200 mg po Tid-Qid α/β-adrenergic stimulation keeps the internal sphincter contracted Several agonist-based medications showed enhanced bladder outlet resistance Numerous side effects (hypertension, anxiety, headache, insomnia, arrhythmia) has led to limited usage Ephedrine, Pseudoephedrine, Phenylpropanolamine, Imipramine 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 8. Wein AJ. Neuromuscular dysfunction of the lower urinary tract and its treatment. In: Campbell’s Urology. 8th ed. Philadelphia, PA: WB Saunders; 2002. 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 19. Andersson KE, Appell R, Cardozo LD, et al. BJU Int. 1999;84:923-947. 27 Miscellaneous Miscellaneous Capsaicin and Resiniferatoxin (RTX) Tricyclic Antidepressants (primarily Imipramine) possess systemic anticholinergic activity/inhibits serotonin/noradrenaline reuptake; works well in elderly patients with doses up to 150 mg/day Botulinum Toxin (BTX) – 7 different toxins (A-G) causes temporary paralysis; BTX-A used to treat DSD; effects last 39 months; 200-300 units over 20 points avoiding Trigone; urinary retention is a risk DSD – Detrusor Sphincter Dyssynergia 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 21. Harper M, Fowler CJ, Dasgupta P. Botulinum toxin and its applications in the lower urinary tract. BJU Int. 2004;93:702-706. 22. Schurch B, Hauri D, Rodic B, et al. Botulinum-A toxin as a treatment of detrusor sphincter dyssynergia: a prospective study in 24 spinal cord injury patients. J Urol. 1996;155:1023-1029. 9. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37 23. Szallasi A, Blumberg PM, Vanilloid (capsaicin) receptors and mechanisms. Pharmacol Rev. 1995;51:159-211. 24. Kim JH, Rivas DA, Shenot PJ, et al. J Spinal Cord Med. 2003;26:358-363. References Most Commonly Used Antimuscarinic Agents to Treat Overactive Bladder Oxybutynin Tolterodine Trospium Ditropan, Ditropan XL, Oxytrol Solifenacin 1. 2. Darifenacin Detrol, Detrol LA Sanctura Sanctura ER Vesicare Enablex Chemical Structure Tertiary amine Tertiary amine Quaternary amine Tertiary amine Tertiary amine Receptor binding Non-selective Non-selective Non-selective Non-selective May be more M3 selective Oral bioavailability Poor (3-15%) Good (75%) Poor (5%) Taken on empty stomach Good (90%) Poor (15-20%) Metabolism CYP 3A4 CYP 2D6 CYP 450 CYP 3A4 CYP 2D6 and 3A4 Excretion Less than 5% active compound in urine Less than 5% active compound in urine Tubular secretion 80% parent compound in urine Less than 15% parent compound in urine 3% active compound in urine Half-life 2 Hrs/13 Hrs 8 Hrs 2 Hrs/9 Hrs 12-20 Hrs 45-65 Hrs 13-19 Hrs Dosing 5 mg bid-tid 5-30 mg q day 3.9 mg 2x/week 1-2 mg bid 2-4 mg q day 20 mg bid 60 mg q day 20 mg q day (elderly/renal ) 5-10 mg daily 7.5-15 mg daily Both belong to the Vanilloid family; extracted from chili peppers and cactus-like plant respectfully which interferes with neuronal pain fibers Vanilloids are ligands of vanilloid receptor type 1 (VR1); both inhibits the release of substance P and cause down-regulation on the bladder Intravesical administration causes improvement in neurogenic urge incontinence and other irritative voiding syndromes Used as topical pain relievers currently Not available for incontinence usage in the U.S. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 7. DeMaagd G, Geibig J. Pharm Thera 2006:31(8): 462-474. 24. Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004;3:46–53. 25. Gormley EA, Lightner DJ, Burgio KL, et al. Urol. 2012;188:2455-2463. 24. 25. Thank You 28 Swift SE. Epidemiology of pelvic organ prolapse and urinary incontinence. In: Bent AE, Cundiff GW, Swift SE, eds. Ostergard’s Urogynecology and Pelvic Floor Dysfunction. 6th ed. Philadelphia: Wolters Kluwer-Lippincott; 2008: 27-38. Abrams P, Cardozo L, Fall M, et al. The standardization of terminology in lower urinary tract function: report from the Standardization Subcommittee of the International Continence Sciety. Urology 2003;61:37-49. Cucchi A, Siracusano S, Guarnaschelli C, et al. Voiding urgency and detrusor contractility in women with overactive bladders. Neurourol Urodyn 2003;22:223-226. Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012; 119 (4):852-860. Pott-Grinstein E, Newcomber JR. Gynecologists’ pattern of prescribing pessaries. J Reprod Med 2001;46:205-208. Schaffer J, Rahn DD, Wieslander CK. Overview of Treatment. In: Bent AE, Cundiff GW, Swift SE, eds. Ostergard’s Urogynecology and Pelvic Floor Dysfunction. 6th ed. Philadelphia: Wolters Kluwer-Lippincott; 2008: 454-462. DeMaagd G, Geibig J. An overview of overactive Bladder and its pharmacological management with a focus on anticholinergic drugs. Pharm Thera 2006:31(8): 462-474. Wein A. Neuromuscular dysfunction of the lower urinary tract and its treatment. In: Campbell’s Urology. 8th ed. Philadelphia: WB Saunders; 2002. Silva W. Pharmacologic management of incontinence and voiding dysfunction. J Pelvic Med Surg 2005;11:1-37. Cholinergic antagonists. In: Harvey RA, Clark MA, Finkel R, et al. Pharmacology. 5th ed. Philadelphia: J.B. Lippincott; 2011: 50-61. Madersbacher H, Stohrer M, Richter R, et al. Trospium chloride versus oxybutynin: a randomized, double-blind, multicentre trial in the treatment of detrusor hyper-reflexia. Br J Urol. 1995;75:452-456. Newgreen DT, Anderson DP, Carter AJ. Darifenacin: a novel bladder-selective agent for the treatment of urge incontinence. Neurourol Urodyn 1995;14:95. Ebinger U. Darifenacin versus oxybutynin for overactive bladder. Poster 4029. Abstract in the 17th World Conference of Family Doctors, Orlando, 2004. Hatanaka T, Ukai M, Ohtake A, etal. In vitro tissue selectivity profile of solifenacin succinate (YM905) for urinary bladder over salivary gland in rats and monkeys International Continence Society Meeting, 2003. Lucente V, Swift S. AYM-905 Study Group. Urgency episodes were statistically significantly reduced with solifenacin treatment for overactive bladder. AUGS/SGS Joint Scientific Meeting Abstracts, San Diego, 2004. Thuroff JW, Chartier-Kastler E, Corcus J, et al. Medical treatment and medical side effects in urinary incontinence in the elderly. World J Urol. 1998;16(suppl 1):s48. Halaska M, Dorschner W, Frank M. Treatment of urgency and incontinence in elderly patients with propiverine hydrochloride. Neurourol Urodyn. 1994;13:428-430. Castleden CM, Duffin HM, Millar AW. Dicyclomine hydrocholride in detrusor instability: a controlled clinical study. J Clin Exp Gerontol. 1987;9:265-270. Andersson KE, Appell R, Cardozo LD, et al. The pharmacological treatment of urinary incontinence. BJU Int. 1999;84:923-947. Harper M, Fowler CJ, Dasgupta P. Botulinum toxin and its applications in the lower urinary tract. BJU Int. 2004;93:702-706. Schurch B, Hauri D, Rodic B, et al. Botulinum-A toxin as a treatment of detrusor sphincter dyssynergia: a prospective study in 24 spinal cord injury patients. J Urol. 1996;155:1023-1029. Szallasi A, Blumberg PM, Vanilloid (capsaicin) receptors and mechanisms. Pharmacol Rev. 1995;51:159-211. Kim JH, Rivas DA, Shenot PJ, et al. Intravesical resiniferatoxin for refractory detrusor hyperreflexia: a multicenter, blinded, randomized, placebo-controlled trial. J Spinal Cord Med. 2003;26:358-363. Andersson KE. Antimuscarinics for treatment of overactive bladder. Lancet Neurol 2004;3:46–53. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline. J Urol. 2012;188:2455-2463. Evolution of Surgical Management of Incontinence: Disclosure Robert T O’Shea I have no financial relationships to FRANZCOG disclose. Flinders Endogynaecology / Urogynaecology Flinders University & Flinders Medical Centre Adelaide, Australia Objectives Treatment Guidelines (AUA 2010) At the conclusion of this activity the participant should be able to: 1. Stress incontinence procedures may be considered in patients with mixed incontinence and significant stress incontinence 1. List the predominant surgical procedures used in the 2. Patients with urge incontinence without SUI should not be offered a surgical procedure for SUI treatment of stress incontinence over the past 30 years. 3. Surgical procedures for SUI and prolapse may be safely performed together. Tensioning of sling should not be performed until prolapse surgery completed 2. List and compare the benefits and drawbacks of various surgical procedures for stress incontinence. 4. Intraoperative cystourethroscopy should be performed in all patients undergoing sling surgery 3. List and compare RPMUS and TOT in the treatment Dmochowski et al (2010) [1] of stress incontinence. Timeline of significant surgical procedures for stress incontinence Timeline Of Significant Surgical Anterior repair: Procedures For Stress • Schultz 1879 – anterior repair • Kelly plication 1913 – wedge of tissue Incontinence to support ureterovesical junction • Ingelman Sundberg 1951 – 1952 bulbocavernosus Rock et al (2008) [2] 29 Timeline of significant surgical procedures for stress incontinence Timeline of significant surgical procedures for stress incontinence Sling: Sling: • Von Giordano, 1907 – gracilis muscle • Goebell 1910 – pyramidalis muscle • Frangenheim 1914 – abdominal wall fascia with pyramidalis • Stoeckel 1917 – same as Frangenheim • Price 1933 – fascia lata • Aldridge 1942 –rectus fascia • Ridley 1974 – description of sling in textbook • Zoedler 1961 – gauze hammock synthetic sling Paravaginal repair: • White 1909 – original description • Richardson 1981 – renewal of White technique Timeline of significant surgical procedures for stress incontinence Timeline of significant surgical procedures for stress incontinence Needle suspension: • Pereya 1959 • Stamey 1973 • Raz 1981 • Gittes 1987 Retropubic: • Marshall-Marchetti-Krantz 1949 • Burch 1968 • Tanagho 1976 – Burch modification Periurethral bulking • McGuire 1994 – Contigen injection • Vancaillie 1991 – laparoscopic Burch Timeline of significant surgical procedures for stress incontinence Inpatient Urinary Incontinence Surgery USA Tension-free synthetic tape • Ulmsten and colleagues 1996 – TVT (tension-free tape) 1998-2007 1998 2007 Retropubic suspensions 52.3% 13.8% Other repair of SUI 22.4% 75.2% • DeLorme 2001 –Transobturator tensionfree tape Wu et al (2011) [3] 30 Stress Urinary Incontinence SISTEr Trial (Albo et al 2007) [4] Burch Colposuspension Longterm Data Alcalay et al (1995) [5] Success – declined for 10-12 years (n=109) plateau 69% success (⅓ repeat cont surgery) Kjolhede (2005) [6] (n=190) 14 year follow up - signif urinary incontinence – 56% - no incontinence episodes – 19% Petros PE, Ulmsten UI (1990)[ 7 ] Midurethral Tapes vs Burch Integral Theory of Incontinence Novara (2010) [8] Midurethral Tapes 31 Cure rates (objective) Increased Cystotomy Increased Burch Suburethral Sling vs Lap Colposuspension Cochrane (2010) (Cochrane 2010) 8 Studies Midurethral Sling Efficacy Pubovaginal Sling Equivalent Equivalent 3 Abstracts (n = 33-133) Follow up 12 m (6-24) Cure / improvement – conflicting evidence Operating time Voiding dysfunction Denovo urgency Sling Ogah et al (2010) [9] urgency (de novo) urgency UI operating time hospital stay RTW QOL – No significant difference TOMUS (Richter et al 2010) [10] TOMUS (Richter et al 2010) [10] n = 597 n = 597 Treatment success 12 months RPMUS TOT 81% 78% • Neg stress test Success • Neg pad test Perforation Voiding difficulty • Absence symptoms • No leakage Groin pain Vaginal erosion • No retreatment Suburethral Sling RPMUS vs TOT (Cochrane 2010) 17 Trials (n = 2434) Transobturator Cure 84% 88% Subjective cure 83% 83% Voiding dysfunction 4% 7% 0.3% 5.5% Cystotomy ISD Retropubic RPMUS TOT + - Ureteric Hypermobility Mod ISD No Detrusor storage abn Healthy vaginal wall RPMUS applies more urethral pressure (ISD) Winters JC et at 2012 [11] 32 RPMUS vs TOT TVT vs TOT SUMMARY RPMUS TVT Low UPP + ISD + Absence urethral hypermobility TOT Less effective • TVT Robust data > 16yrs • ↑ Efficacy for SUI • Haematoma (retropubic), cystotomy, voiding dysfunction, OAB. TOT failure Liopis A, et al (2004) [12] Lo TS et al (2002) [13] • Equivalent SUI • Reduced OAB • Reduced groin pain TVT – Longterm data Nilsson et al 2013 [14] TVT – Longterm data n = 90 • Follow up 17 years Svenningsen et al 2013 [15] • TVT (1998–2000) (78% clinic/telephone) (n = 603) (f/u 483) • 3 Nordic centre • Objective continence • 4 Norway centres >90% • Subjective cure/improve 78% • Objective cure 89.9% • Subjective cure 76.1%. Minislings vs Standard MUS Monarc vs Miniarc Meta-analysis RCT (Monash-12m) 9 RCT’s (n=758) Follow-up 10m • Lower subjective/objective cure rates • Decreased operating time • Decreased groin pain • Increased repeat surgery Abdel-Fattah et al 2011[16] 33 Monarc Miniarc Subjective Cure 94% 92% Objective Cure 96% 94% OAB (medication) 15% 5.7% Groin Pain 7% 0 Intrinsic Sphincter Deficiency Pelvic Organ Prolapse RPMUS vs TOT (RCT) To Sling or not to Sling (RCT) USI plus ISD (MUCP < 20) POP + TVT n=37 (LPP < 60) POP w/o TVT n=43 Required repeat surgery (USI) RPMUS TOT 6.1% 19.9% 10 TVT’s to prevent 1 SUI (postop) Schierlitz et al (2008) [17] Schierlitz et al (2008) [17] Stress Incontinence Stress Incontinence Urethral bulking agents Urethral bulking agents Biological Synthetic • Silicone particles (MacroplastiqueTM) FDA • Calcium hydroxylapatite (CoaptiteTM) Mechanism • Porcine dermis (Permacol ) • Mechanical support to bladder neck • FDA TM • Glutaraldehyde cross-linked bovine collagen (ContigenTM) Increased urethral resistance • Carbon beads (DurasphereTM) • Polyacrylamide hydrogel (Bulkamid ® ) Stress Incontinence Conclusion Urethral bulking agents Incontinence Surgery Evolution • SUI – Primary & secondary • Cure < surgery 1879-2013 Laparotomy – Laparoscopy – RPMUS Stress Urinary Incontinence (SUI) » » » » Contigen – cure 53% Bulkamid – cure 64% (2m) Gold Standard = Midurethral Sling TVT vs TOT Mini Slings Urethral bulking agents Prolapse/SUI » Adjunctive prolapse procedure Davis NF, et al (2013) [18] 34 (Vag or laparoscopic) References References 1. Liopis A, Bakas P, Lazaris D et al. Tension-free vaginal tape in the management of recurrent stress incontinence.Arch Gynecol Obstet (2004); 269 (3): 205-7. Rock JA, Jones HW, “Te Linde’s Operative Gynecology” Tenth Edition, Wolters Kluwer, Lippincott Williams & Wilkins, 13. 14. 15. N Engl J Med (2007); 356(21) : 2143-55 Alcalay M, Monga A, Stanton SL. Burch colposuspension: A 10-20 year follow up Br J Obstet Gynaecol 102 (9): 740-745 6. Kjolhede P. Long-term efficacy of Burch colposuspension: A 14 year follow up study. Acta Obstet Gynecol Scand 84(8): Schierlitz L, Dwyer P, Rosamilia A. Effectiveness of Tension-Free Vaginal tape compared with Transobturator Tape in women with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency. Novara G, Artibani W, Barber MD, et al. Updated systemic review and meta-analysis of the comparative data on Obstet Gynecol (2008) 112:1253-67. 18. Urol (2010); 58(2) : 218-38. 10. meta-analysis of effectiveness and complications. European Urology (2011) 60;468-480. 17. colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress incontinence. Eur 9. Abdel-Fattah M, Ford J, Lim C et al. Single incision mini slings vs standard midurethral slings in surgical management of female stress urinary incontinence: Petros PE, Ulmsten UI. An integral theory of femal urinary incontinence; experimental and clinical considerations. Acta Obstet Gynecol Scand (1990); 69 Suppl 153:7-31. 8. Svenningsen R, Staff A, Hjalmar A et al. Long-term follow up of the retropubic tension-free vaginal tape procedure. Int Urogynaecology (2013); 24:1271-1278. 16. 767-772. 7. Nilsson CG, Palva K, Aarnio R, et al. Seventeen years follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynaecology J (2013); 24:1265-1269 Albo ME, Richter HE, Brubaker L, et al Burch colposuspension verses facial sling to reduce urinary stress incontinence. 5. Lo TS, Horng SG, Chang CL et al. Tension-free vaginal tape procedure after previous failure in incontinence surgery. Urology 2002; 60: 57-61. Wu J M, Gandhi M P, Shah A D et al. Trends in inpatient urinary incontinence surgery in the USA, 1998-2007. Int Urogynaecol J (2011) 22:1437-1443. 4. 12. selection. Can Urol Assoc J 2012;6(5):S118-9. 2008 p944. 3. Winters JC. Surgical management of stress urinary incontinence: A rational approach to treatment Dmochowski RR, Blaivas JM, Gormley EA, et al Update of AUA Guidelines of surgical management of stress incontinence. J UROL (2010); 183(5) : 1906-14 2. 11. Davis NF, Kheradmand F, Creagh T. Injectable biomaterials for the treatment of stress urinary Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in incontinence: their potential and pitfalls as urethral bulking agents. Int Urogynaecol J (2013); 24:913- women (review) The Cochrane Collaboration 2010 Issue 1. 919. Richter HE, Albo ME, Zyczynski HM, et al. Retopubic verses transobturator midurethral slings for stress incontinence. N Engl J Med 2010:362(22):2066-76. 35 Disclosures Does She Have Prolapse? Obliterative or Reconstructive Surgery VincentLucenteMD,MBA MedicalDirector,TheInstitutefor FemalePelvicMedicineand ReconstructiveSurgery ChiefofGynecology,St.Luke’sHospital ClinicalProfessorOb/Gyn Temple Objectives Grants/Research Support: American Medical Systems, Bard Medical Division, Kimberly-Clark Consultant: Allergan, American Medical Systems, Bard Medical Division, Kimberly-Clark Speakers Bureau: Allergan, American Medical Systems, Bard Medical Division Pelvic Organ Prolapse By the end of this lecture you: Should learn the components of pelvic organ prolapse in terms of distension vs. detachment Should be able to do POPQ staging Should learn the different surgical treatment options available and effectively council patients in order to facilitate shared decision making and selection of the most appropriate surgery for them Should learn the risks and benefits of synthetic graft augmented reconstructive pelvic surgery “The Uterus is Falling” POP/ Native Tissue What Causes POP? Multiple studies confirm that women with POP have a Genetic predisposition Exact causes unknown, but likely multifactorial Defective genital support response to ‘normal’ intra-abdominal forces or ‘normal’ supports chronically subjected to high intra-abdominal forces Risk factors can be classified as: predisposing, inciting, promoting, or decompensating events Established vs. Potential Risk Factors Uterosacral ligament biopsies with prolapse Chen BH et. al. Int Urogyn J 2006;17(Suppl 3):S409 Weislander CK et.al. Int Urogyn J 2006;17(Suppl 3): S406-7 Gabiel B et.al. Int Urogyn J 2006;17(5):478-82 Jack GS et.al. Int Urogyn J 2006;17(5):498-501 Phillips CH et.al. BJOG 2006;113(1):39-46 Ozdegirmenci Oet.al. Int Urogyn J 2005;16(1):39-43 Poncet S et.al. Am J Obstet Gynecol 2005;192(2):426-32 Soderberg MW et.al. Acta Obstet Gynecol 2004;83(12)1193-8 Wong MY et.al. Am J Obstet Gynecol 2003;189(6):1597-9 Boreham MK et.al. Am J Obstet Gynecol 2002;187(1):56-63 Goepel C et.al. Acta Obstet Gynecol Scan 2003;82(7):659-64 36 without prolapse Visco AG et.al. Am J Ostet Gynecol 2003;189(1):102-12 Chen B et.al.Neurourol Urodyn 2004;23(2):119-26 Goh JT Cur Op Obstet Gynecol 2003;15(5):391-4 Ewies AA et.al. H Repro 2003;18(10):2189-95 Takano CC et.al. Int Urogyn J 2002;13(6):342-5 Kokcu A et.al. Arch Gynecol Obestet 2002;266(2):75-8 Liapis A et.al. Eur J Obstet Gynecol 2001;97(1):76-9 Yamamoto M et.al. Cell Biol Int 1998;22(1):31-40 Jackson SR et.al. Lancet 1998;347(9016):1658-61 Jackson SR et.al. Lancet 1998;347(9016):1658-61 Stanosz S et.al. Ginekol Pol 1995;66(9):518-22 Established and Potential Risk Factors for Pelvic Organ Prolapse Established risk factors 3. Vaginal delivery Advancing age Obesity Potential risk factors 1. Obstetric factors Family history POP Race Connective‐tissue disorders/ genetic factors Constipation, chronic straining or heavy lifting Previous Hyst, (especially w/o concurrent culdoplasty) 1. 2. 2. 3. 4. 5. 6. Background Pelvic Organ Prolapse Prevalence Demographic factors and changing patient expectations …‘50 is the new 40’ Next 30 yrs the rate of women who will seek treatment for POP will double POP is the ‘indication’ for approx 7-14% of all hysterectomies for benign disease Annual number of corrective surgeries and related health care costs will no doubt rise POP Procedural Demand POP in > 50% of women over 501 Lifetime prevalence of 30-50%1 Women > 65 is the fastest growing segment of the US population2 Demand for services expected to double in the next 30 years3 11% risk of surgical intervention by age 801 226,000 procedures performed in 19972 Cost > 1 billion3 Estimated number in 2030 is 7 million4 Represents a small subset of symptomatic patients 1Olsen 2 Brown 2US 3Subak LL et.al. Obstet Gynecol 2001;98:646-51 Census Bureau 2000 Int data base 3Luber KM et.al. Am J Obstet Gynecol 2001;184:14961501 51 4Shull B Am J Ob Gyn 1999;181:6-11 POP Location1 et.al. Obstet Gynecol 1997;89:501 JS et.al. Am J Ob Gyn 2002;186:712 LL et.al. Obstet Gynecol 2001;98:646- 1Subak DeLancey Levels of Support Anterior only40% Anterior and apex20% Posterior only7% Posterior and apex10% All three compartments18% Anterior compartment involved78% Highest failure in Ant. Compartment Olsen A et.al. Obstet Gynecol reported from 30-70% 2,3,4,5,6 1997;89:501 ’92 ’95 4Samuelsson 5Shull Paravaginal attachments‐ paracolpium Distal Fusion (DeLancey level III) 3Holley Cardinal/U.S. “ligament” complex Lateral Attachment (DeLancey level II) 1 2Shull Apical Suspension (DeLancey level I) Perineal membrane/body ’99 ’00 ‘01 DeLancey, JO Am J Ob Gyn 1992; 166:1717 6Weber 37 Detachment vs. Distention Support Structures Detachment- Intact vaginal fibromuscular envelope Separated from supporting structures Allows descent (prolapse) of the intact envelope with over or underlying organs into the vaginal cavity Distention Defect within the vaginal fibromuscular envelope itself Remains attached to supporting structures Allows herniation of the over/underlying organs in direct contact with vaginal epithelium into the vaginal cavity Cardinal/Uterosacral Complex Paracervical Ring Arcus Tendineus Fascia Pelvis ATFP Fascia Endopelvina (paracolpos) Pubocervical “fascia” Rectovaginal “fascia” Detachment Pubourethral “ligaments” Distention Distension Loss of Apical support Detachment vs. Distention Vaginal Vault Detachment Vaginal Vault Detachment and Distention Complete U‐V Prolapse Uterosacral ligament detached from pericervical ring at level of ischial spines Upon valsalva, lateral fornices bulge due to detachment from cardinal ligament With progression antero‐lateral sulci collapse as lateral detachment from the ATFP ensues Cervical elongation has been observed with uterine prolapse, may need to consider when performing uterine preservation RPS In post‐hyst vault prolapse, enterocele formation is more common Cystocele 38 Anatomic Considerations Anterior Compartment Lateral Detachment Defect ? Detachment Cystoceles Distention Cystoceles A Cullen Richardson Rectocele Pelvic Organ Prolapse Do you “POP-Q”? ICS Pelvic Organ Prolapse Ordinal Grading/Staging System (POP‐Q) Halfway system for Grading Urethrocele, cystocele, uterine prolapse, rectocele: (while straining) Grade 0: Grade 1: Grade 2: Grade 3: Grade 4: normal position descent halfway to the hymen descent to hymen descent halfway past the hymen maximum possible descent Stage 0 Points Aa, Ap, Ba, and Bp are all at -3 cm and either point C or D is at no more than -(X-2) cm Stage I The criteria for stage 0 are not met and the leading edge of prolapse is less than -1 cm Stage II Leading edge of prolapse is at least -1 cm but no more than +1 cm Stage III Leading edge of prolapse is greater than +1 but less than +(X-2) cm Stage IV Leading edge of prolapse is at least +(X-2) cm X= total vaginal length in cms 39 40 Treatment Options Simplified POP‐Q Stage 1 – Prolapse at least 1 cm above hymenal ring Stage 2 – Prolapse 1cm above to 1 cm below hymenal ring Stage 3 – Prolapse past introitus but not complete eversion or procedentia Stage 4 – Complete eversion or procedentia Non-surgical options - do ‘nothing’…serial observation - pessary placement…sucessful long term management can be challenging - PME/kegels…may only slow progression Surgical options: Obliterative vs Reconstructive -Various ‘approaches’ (open, endoscopic, vaginal) - Suture based native tissue repair vs graft placement *If one segment is stage 4 then all are stage 4 Obliterative Procedures Obliterative Procedures “Colpocleisis” from the Greek kolpos = folds or hollow, and cleisis = closure. First reported in 1823 by Gerardin. Current technique is a modification of that first described in 1877 by Leon Lefort High success rates >90% Several retrospective cohort studies reported comparable satisfaction after obliterative versus reconstructive surgery Regret over the loss of the ability to have vaginal intercourse has been reported in up to 13% of women who had an obliterative procedure Patient selection is crucial: LeFort Colpocleisis Age No longer sexually active Significant comorbidities Advanced stage III – IV prolapse Cervical and/or uterine pathology has been excluded Symmetry of the defect Colpectomy 41 Quality of life and surgical satisfaction after vaginal reconstructive vs obliterative surgery for the treatment of advanced pelvic organ prolapse Murphy et al. Am J Obstet Gynecol. 2008 May;198(5):573. Retrospective cohort study 90 pts following reconstructive vs obliterative surgery Pre and Post operative responses to the UDI-6 and IIQ-7 plus the Surgical Satisfaction Questionnaire (SSQ-8) were analyzed. Improvements in condition-specific quality of life and postoperative patient satisfaction measures are comparable in women with prolapse who undergo either reconstructive or obliterative surgery Obliterative procedure Prolapse Obliterative procedure Sequential closure Separate into quadrants Obliterative procedure Final layer of sutures Surgical Management Obliterative Surgical Management - Obliterative Colpectomy and Closure of the Genital Hiatus Colpectomy and Closure of the Genital Hiatus 42 How have we done with ‘traditional’ Surgical Reconstruction for POP? Possible Causes of Failure 11.2% lifetime risk of surgical intervention1 29-40% of reconstructive procedures require surgical reintervention for failure within 3 years1,2 60% of recurrences are at the same site3 32.5% occur at a different site due to unmasking of an occult support defect3 Reoperation is the “tip of the iceberg” 1Olson Anatomic Neurogenic/Myopathic Tissue Factors (collagen content and structure) Environmental Factors Surgical Factors Healing and “scarring” does not replace or add tensile strength, thus failing to restore or maintain normal anatomic position and function over time AL, et.al. Obstetrics and Gynecology 1997; 89:501-6 2 Marchionni M, et al. Journal of Reproductive Medicine 1999;44;679-84 3 Clark AL, et.al. American Journal of Obstetrics and Gynecology 2003;189:1261-67 CARE: Complications ASC: the “Gold Standard” STRENGTHS Group WEAKNESSES Burch (n=153) All SAE 56(42 pts) 36.6% Longitudinal Surgical SAE Known Ileus outcome data General Anesthesia risks Length of hospital stay Low graft complication rates Laparotomy morbidity Pain Concomitant hysterectomy access Respiratory compromise Satisfactory sexual outcome data function Small bowel obstruction Ileus Thrombosis Incisional hernia 15 (9.8%) 22 (13.9%) 11.9% 11 (7.2%) 10 (6.3%) 6.8% Inc. Hernia 3 (2%) 4 (2.5%) 2.3% Wound Complications 5 (3.3%) 6 (3.5%) 3.5% 1.3% 8 (5.2%) 12 (7.6%) 6.4% Recovery Repeat surg. prolapse 2 (1.3%) 6 (3.8%) 2.3% Cosmesis Surg tx SUI 7 (4.6%) 15 (9.5%) 7.1% Burch (n=117) No Burch (n=133) p value - 8.0 + 1.5 - 8.2 + 1.3 .46 Ba - 2.2 + 0.9 - 1.8 + 1.1 < .001 Bp - 2 + 1.3 - 2.3 + 0.8 .006 *mean Burch (n=117) 24 (20.5%) 1.3% Other Mesh/suture Erosion C Stage 0 2.6% Ileus CARE: Anatomic Outcomes POP-q Total 38.6% Total Reop Rate Bowel Point* No Burch (n=158) 64(49 pts) 40.5% Minimally Invasive Revolution Goals: -Emulate the outcomes attained with ASC -Lower the morbidity -Improve the patient experience + SD No Burch (n=133) 23 (17.4%) Total 18.8% I 43 (36.8%) 51 (38.6%) 37.6% II 46 (39.3%) 57 (43.2%) 41.2% III 4 (3.4%) 1 (0.8%) 2% > II 50 (42.7%) 58 (44%) 43.2% Laparoscopy-GA, learning curve, OR time, conversion Robotic- enormous expense, ease of use, “cool factor” ? Vaginal implantation Mean POSQ-12 = 37.3/48 43 “Overlay” of standard repairs- failure & exposure Unsecured- High rates of failure in high degree prolapse Sutured- high complication rates Tension-free securement- most promising Who thinks anatomic cure is better with TVM compared to NT? My “Evolution” In the Approach to Pelvic Reconstruction “Nonabsorbable synthetic graft use may improve anatomic outcomes of anterior vaginal wall repair, but there are trade-offs” As early as 1996 (T. J.) 2005- Present Increasing EvidenceBased Validation of The Transvaginal Mesh Approach 2005: Transvaginal Mesh Techniques continued to be developed and refined We do… SGS SRG CPG – November 2008 1990’s Laparoscopic Approach: Native and Augmented *1996 Mesh vs Approach 1990: Native Tissue… Vaginal vs. Abdominal? The FDA - July 2011: TVM… The Cochrane Review - November 2011 “may provide an anatomic benefit compared to traditional POP repair” “Native tissue anterior was associated with more anterior compartment failures than polypropylene mesh” repairs. The “Beginning” of Transvaginal Synthetic Mesh Placement: TVT 1998 ACOG Committee Opinion 513 – December 2011 2003: Trans-vaginal Approach to mesh Augmentation in PRS “Based on available data, transvaginally placed mesh may improve the anatomic support of the anterior compartment compared with native tissue repair” Benefit Beyond Short-Term Anterior Anatomy Anatomic Outcomes - Anterior Study Hiltunen/Nieminen 2007, 2008, 2010 Sivaslioglu 2008 Nguyen 2008 Carey 2009 Withagen 2011 Altman 2011 Menefee+ 2011 Sokol /Iglesia 2012 Halaska 2012 Number of Patients 202 Compartment Studied Anterior 90 Length (months) 12 24 36 12 Native Cure Anatomic 62% 59% 59% 72% P value Anterior Mesh Cure Anatomic 93% 89% 87% 91% 76 12 Anterior 87% 55% .005 139 12 194 Anterior & Posterior All 81% 65.6% 0.07* 12 92.2% 44.9% <.001 389 12 Anterior 82% 48% <.001 99 24 Anterior 82% 42% .002 65 12 All 53% 39% 0.30¥ 168 12 All 83% 61% .003* + <.001 <.001 <.001 <0.05 Recurrent Posterior Compartment Prolapse 20111 Multicenter (13 sites) RCT in Netherlands: 12 mo’s F/up 186 of 194: Tx’d Ant=100, Post=106, Apic=88 ≥ Stage 2 or repeat sx: 14/57 (25%) vs 2/49 (4%), P=.003 in favor of synthetic mesh over NT Correction of Apical Compartment Prolapse 20122 Multicenter (5 sites) RCT in Czech Republic: 12 mo’s Overall success: 61% SSLS vs 83% TVM, P=.003 Point C: -5 vs -6 cm proximal to hymen, P=.016 1Withagen 2Halaska Benefit Beyond Short-Term Anterior Anatomy Trade-offs Most RCT’s powered for objective cure at 1yr Only 1 powered for 10 composite outcome One unique risk: graft erosion Average rate: 10.3% synthetic & 10.1% biologic1 Site variation (0-100%)2 & experience (25% 2%)3 Multicenter (53) RCT of 389 Nordic women1 Objective and Subjective success in 61% vs 35% No symptom of bulge at 1yr: 62% vs 75%, P<.001 MI et al. Trocar-guided mesh compared with conventional… recurrent prolapse. Obstet Gynecol 2011;117:24250. M et al. A multicenter RCT comparing.. in..posthysterectomy vaginal vault prolapse. AJOG 2012;301.e1-e7. Contraction?: TVL, chronic pain, dyspareunia The 2010/11 Cochrane update + new literature reveals 10* RCT’s comparing TVM to NT: All but two measured change in TVL Four measured pelvic pain All but one measured dyspareunia RCT of 202 women, 180 with 3yr f/up2 One yr: Symptom of vaginal bulge TVM < NT, P=.02 Three yr: Anatomic recurrence: 41% vs 13%, P<.001 Three yr: Symptom of bulge: 19% vs 10%, P=.07 1Abed 1Altman D et al. Anterior colporrhaphy vs TVM for POP. NEJM 2011;364:1826-36. K et al. Outcomes after anterior vaginal wall repair with mesh: RCT 3year f/up. AJOG 2010;235.e1-8. H, et al. Incidence and management of graft erosion… a systematic review. IUJ 2011;22:789-98. GR, et al. Use of Gynecare Prolift… 1-year outcome. IUJ 2011;22:869-77. is an RCT of NT, synthetic, and biologic graft in anterior compartment. 2Vaiyapuri 2Nieminem *One 44 Vaginal Length Study Hiltunen/Niemine n 2007, 2008, 2010 Sivaslioglu 2008 Nguyen 2008 Carey 2009 Lopes 2010 Withagen 2011 Altman 2011 Menefee* 2011 Sokol /Iglesia 2012 Halaska 2012 Number of Patients 202 Length (months) 12,24,36 Compartment Native TVL Change ‐0.5 P value Anterior Mesh TVL Change ‐0.4 90 12 Anterior 0 0 0.92 76 12 Anterior ‐1 ‐1 NS 139 12 NR NA 12 Anterior & Posterior Posterior/Apical NR 32 ‐2.2 ‐2.9 NS 194 12 All 0 0 0.21 Pelvic Pain 0.80 Study 389 12 Anterior 0 ‐0.5 0.13 99 24 Anterior NR NR NA 65 12 All ‐1 ‐1 0.35 168 12 All ‐0.4 ‐0.8 0.30 Sexual Health Study Hiltunen/Niemine n 2007, 2008, 2010 Sivaslioglu 2008 Nguyen 2008 Carey 2009 Lopes 2010 Withagen 2011 Altman 2011 Menefee* 2011 Sokol /Iglesia 2012 Halaska 2012 Number of Patients 202 Length (months) 12, 24+, 36 Compartment Anterior Mesh Sexual Health Adverse Effect 18% Compartment Mesh Pain Native Tissue Pain P value Sivaslioglu 2008 90 12 Anterior 2.2% 8.9% NS Withagen 2011 194 12 All De Novo 7.5% De Novo 4.0% 0.44 Altman 2011 389 12 Anterior 0.5% 0% 1.00 Halaska 2012 168 12 All 8.1% 5.5% 0.73 P value • Mesh is clearly “needed” for long term success for repair of apical/anterior defects • New lighter, more elastic “hybrid” monofilament meshes may offer even better post operative function • Transvaginal delivery is minimally invasive, technically easier than laparoscopic, and much more cost effective than robotic • Data although not robust, is rapidly growing with several level I studies completed that when properly performed, transvaginal delivery of the mesh is safe and effective NS 90 12 Anterior De Novo Dyspn 4.6% De Novo Dyspn 0% ND 12 Anterior De Novo Dyspn 9% De Novo Dyspn 16% 0.67 139 12 Anterior & Posterior Apical De Novo Dyspn 16.7% De Novo Dyspn 15.2% 0.46 ND ND NA De Novo Dyspn 8% De Novo Dyspn 10% 0.75 0.99 12 Length (months) Why is transvaginal mesh beneficial? Native Tissue Sexual Health Adverse Effect 20% 76 32 Number of Patients 194 12 All 389 12 Anterior PISQ Improved 2.8 points PISQ Improved 2.0 points 99 24 Anterior De Novo Dyspn 7.1% De Novo Dyspn 12.5% NS 65 12 All De Novo Dyspn 9.1% De Novo Dyspn 21.4% 0.60 168 12 All PISQ Improved 2.5 points PISQ Improved 6.7 points NS FDA Public Health Notification When is TVM not Beneficial? The mesh (post inplant) has undesired biomechanical properties Patients are not properly and fully informed of the risk and benefits of the TVM procedure There is suboptimal execution of the surgery * dissection * delivery/placement * setting/adjustment Obtain specialized training specific to each tech. Be vigilant for adverse events, especially erosion Watch for complications assoc. with placement Inform patients implantation is permanent, some complications may require addn. surgery Educate pts. Re: serious complications effect on QOL, including possibly dysparunia Provide pts. with copy of patient labeling from manufacturer (if available) www.fda.gov 45 Dedicated Office Consent When Informed Consent Is Not Enough With a lack of clear guidelines for mesh use and avoidance, emphasis must be placed on individual patient risk assessment and open counseling between the patient and physician. “The patient was advised regarding various surgical options including abdominal, laparoscopic and vaginal approaches. The risks and benefits of surgery using endogenous tissue only versus the use of graft insertion (mesh) were fully reviewed. The patient was informed of the potential for improved durability (as long-term studies are still not available) and the inherent risks of graft use including, but not limited to, infection, erosion, and chronic inflammation, acute and chronic pain, pain with intercourse, (both of which can be refractory to treatment) fistula, disturbance in bowel or bladder function, any of Dedicated Office Consent (con’t) DISSECTION which may require additional surgery for the mesh revision. The patient is aware of the relatively limited medical data comparing native tissue repairs to transvaginal synthetic graft repairs to date, and that some physicians consider their use to be lacking in sufficient “scientific” medical evidence even though FDA approved. The patient was advised regarding the July 13, 2011 FDA notification regarding these issues and provided the website address for further reference www.fda.gov. The patient was provided a written copy of the patient labeling from the surgical mesh manufacturer”. The most “difficult” step in transvaginal mesh delivery procedures The make or break point for achieving a low exposure rate Can be extremely challenging in patients with prior retro-pubic or para-vaginal dissection Histology of Vaginal “Fascia” The Importance of Depth Mesh Exposure } Non-Keratinized Stratified Squamous Epithelium Directly fused on: With ASC – 0.5% using polypropylene Vaginal Implantation – 3-19% WHY??? Source: Bailey’s Textbook of Histology Williams & Wilkins 1971 46 Thin Lamina Propria Concentric Layers of Smooth Muscle Fibrous “Coat” derived from Dense Irregular connective tissue Endopelvic “Fascia” Anterior Vaginal Wall Anatomy Surgical placement of Mesh Iatrogenically bisected vaginal wall Compartment1 Literature review 80 articles anterior repair vagina has three layers-mucosa, muscularis, and adventitia; there is no vaginal "fascia." “Dissection during anterior colporrhaphy splits vaginal muscularis, and repair involves plication of the muscularis and adventitia (not vaginal "fascia")” Vaginal Fibromuscular wall “The Posterior •non-keratinized stratified squamous epithelium Bladder Wall fused with •concentrically arranged smooth muscle ▓ compartment2 Cadaveric dissection of the RV “septum” is no evidence of a distinct fascial layer between the posterior vaginal wall and the anterior wall of the rectum” “It is the splitting of the adventitial layer from the overlying vaginal wall that accounts for the “fascial layer” seen surgically” Fascial “capsule” “There •formed from condensation of irregular loose areolar endopelvic connective tissue 1Weber A, Walters M. Obstet Gynecol 1997;89(2):311-8 2Kleeman et.al. Paper #10 SGS 2005 True vesicovaginal space ▓ Potential graft placement sites Reiffenstuhl, et al, Vaginal Operations, 1994 Improper Mesh Placement Cundiff: Obstet Gynecol, Volume 104(6).December 2004.1403-1421 Dissection Technique Hydrodissection Access to the correct anatomic spaces minimizes bleeding mobilizes/avoids hazards (ureters, bladder, blood vessels) allows anatomically correct graft placement Potentially minimizes exposure risk Literature review 80 articles anterior repair “Dissection during anterior colporrhaphy splits vaginal muscularis, and repair involves plication of the muscularis and adventitia (not vaginal "fascia")” Posterior compartment1 Tuohey needle Anterior Compartment1 Hydro-dissection Arguably the most important aspect of transvaginal mesh augmentation Cadaveric dissection of the RV “septum” “It is the splitting of the adventitial layer from the overlying vaginal wall that accounts for the “fascial layer” seen surgically” 47 18g Epidural needle 5mm gradations for depth Rounded (non-cutting) tip Hydrodissection* Hydrodissection Guidance Set yourself up for success with manipulation of the vaginal wall Place 2 allis clamps on the vaginal wall Pinch back against the bladder to potentiate space Use a 22 bevel or Touhey needle Use at least > 60cc per dissected compartment 60cc marcaine w/ epi diluted with 60cc injectable saline Hold sagitally and displace bladder Little resistance should be encountered No “wheal” in epithelium (too superficial) Extend laterally using standard needle Hydrodissection is critical (20-80cc) Getting to the true Vesicovaginal/Rectovaginal space is critical. Tips exist for identifying this space avoid blanching and wheal space is path of least resistance *Prolift consensus forums 2005 Anterior Hydrodissection Full thickness vaginal wall True vesicovaginal space Fluid bubble Pubocervical fascia Primary Responder: Dr. Heather van Raalte True vesico-vaginal space Paravesical fat 48 Do Synthetic Grafts Increase the Success of Transvaginal Repair of Pop? + Benefit Do Synthetic Grafts Increase the Success of Transvaginal Repair of Pop? + Benefit No Benefit Safety of Transvaginal Mesh No Benefit So…Where are we now? Serious adverse event rate is low Serious mesh-specific adverse event rate is very low Adverse event rate is comparable to traditional surgery Mesh-specific adverse events are manageable Study design for 522 trials near completion Several companies will be participating AUGS “registry” will allow for tracking options creating opportunities for various sub populations and analysis MSIG – has been formalized allowing high volume TVM experts to Current marketplace be part of process June 4, 2012 J & J announces that the Gynecare division will be no longer be selling Prolift, Prolift+M, Prosima and TVT Secure in the US Legal ramifications Multi district suit Recent AUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders “In some circumstances transvaginal mesh for POP may be the most appropriate surgical option” A review of more current studies from 2011 and 2012 suggest that transvaginal mesh placed by experienced mesh surgeons may have mesh erosion rates comparable to abdominally placed mesh Pro: the contemporary use of transvaginal mesh in surgery for pelvic organ prolapse. Krlin RM et al. Curr Opin Urol, 2012 22(4): p282-6 http://www.augs.org 49 Encourage Patients to Write to the FDA about their Positive Experiences Path forward Develop effective robust communication tools for patients to better understand how/why the benefits outweigh the risks of TVM for their individual situation (including brief hx of what has transpired) Be balanced when discussing surgical options for mesh delivery to pelvis i.e. endoscopic vs. vaginal approach In your documentation, utilize recommended guidelines on risk factors for recurrence that establish whether TVM is appropriate Recommit to enhancing your knowledge in material science of synthetic construct and your surgical skill set in performing TVM procedures Summary Summary With changing demographics as well as the higher expectations on the demand for effective treatment for POP, Gyn surgeons will be facing the challenge to meet patient expectations Proper diagnosis of the nature of the support defects comprising the pts POP is critical to planning appropriate surgical options Careful quantitative staging of POP is also key to accurate pre- and post-operative assessment Both obliterative and RPS can be appropriate in properly selected and counseled patients Conclusion For many patients the era of reconstructive pelvic surgery limited to the use of native tissues is ending. We are facing a new era in which material science and surgical techniques will continue to bring advancements in surgical treatments that will potentially improve our patients experience and long term functional outcomes. The biggest challenge will be the decisions that we face in when and how to incorporate their use. 50 Native tissue repairs for POP leave room for outcome improvement, especially durability Material science innovation can offer advances in long term successful outcomes Traditional abdominal techniques using mesh are morbid and difficult for patients Minimally invasive vaginal or endoscopic mesh implantation lowers morbidity which can lead to an improved patient experience Occult Incontinence: To treat or not? Disclosure I have no financial relationships to disclose. Neena Agarwala, MD, MSc Associate Clinical Professor St. Luke’s Roosevelt Hospital Medical Center Columbia University Affiliate New York, NY Objective Occult Incontinence Review the basic concept of occult incontinence Definition: SUI that is not symptomatic but becomes apparent only during clinical or urodynamic testing (i.e. cough stress test after prolapse reduced) Denovo SUI : SUI that is newly symptomatic, as when SUI develops after prolapse repair in a woman who was continent before surgery Occult SUI Patient perspective • Diagnosed using pre‐operative prolapse reduction testing in 31‐80% of continent women with symptomatic and/or advanced prolapse who are planning to have surgery • When these women undergo prolapse repair without a concomitant continence procedure, the rate of post‐operative denovo SUI is 13‐ 65% • Prolapse is bothersome • Incontinence is debilitating 51 Clues to detecting occult SUI Diagnosis of Occult SUI • Incontinence that improves or resolves as prolapse worsens • The need to manually replace the prolapse structures in the vagina to void • Worsening or development of SUI with use of pessary • Medical history • Clinical or urodynamic testing with and without reduction of prolapsed organs • Prolapse reduction can be done by fingers, cotton swab, speculum blade, ring forceps, or pessary. One is probably not superior to another, except that the pessary is the least diagnostic. POP with no symptoms of SUI Elevation of bladder neck relieves the kink • Most experts consider women with positive testing for occult SUI to be similar to women who have SUI symptoms, and advise combined surgery for prolapse and SUI • However, it is controversial what to do to the bladder neck in women with symptomatic prolapse but no SUI on pre‐operative testing with reduction, especially for POP surgery by the vaginal route Risk of developing postoperative SUI in women undergoing surgery for POP (UpToDate 2011) Risk of developing SUI in women undergoing surgery for POP +clinical sxs of SUI Women undergoing surgery for POP No incontinence surgery Incontinence Surgery Borstad 2006 65/90 (72%) Colombo 1997 SUP 6/15 (40%) Colombo 2000 19/33 (58%)* Colombo 1997 NS 6/21 (29%) De Tayrac 2004 5/14 (36%) Colombo 2000 RPU 5/35 (14%)* De Tayrac 2004 TVT 1/15 (6.7%) Partoll 2006 TVT 2/37 (5%)* Wille 2006 RPU 0/14 (0%)* Total : 89/137 (65%) Total : 20/137 (15%) * Denotes abdominal procedures No clinical sxs of SUI Clinical sxs of SUI 52 Risk of developing postoperative SUI in women undergoing surgery for POP Risk of developing postoperative SUI in women undergoing surgery for POP No clinical symptoms of SUI ‐ occult testing No Clinical sxs of SUI +occult stress testing No incontinence surgery Incontinence surgery No incontinence Surgery Incontinence Surgery Bergman 1998 0/43 (0%) Chalkin 2000 0/10 (0%) Colombo 1990 4/62 (8%) Kutke 2000 0/20 (0%) Liang 2004 0/30 (0%) Reena 2007 0/25 (0%) Visco 2008 41/109 (38%)* Total : 45/289 ( mean 16%) Bump 1996 SUP 0/5 (0%) Bump 1996 NS 0/4 (0%) Colombo 1996 SUP 4/50 (8%) Visco 2006 RPU 22/106 (22%)* Wille 2006 RPU 0/14 (0%)* Total : 26/179 ( 15%) In the 2006 CARE trial, sacrocolpopexies were done with and without Burch De Tayrac 2004 1/6 (13%) Liang 2004 11/17 (65%) Reener 2006 34/53 (80%) Visco 2008 23/40 (50%)* 17 studies 1996‐2000 Total : 69/118 (59%) Total: 76/502 (15%) Burch sutures • In women with POP having ASC who were continent before surgery, Burch decreased the rate of post‐operative SUI ( 32% for Burch vs 45% for no Burch) • For women with occult SUI on pre‐testing, 37% had SUI after Burch and 60% had SUI after no Burch • For women with no occult SUI on pre‐testing, 20% had SUI after Burch and 39% after no Burch OPUS Trial Controversy • In this multicenter RCT, 337 women without SUI but having vaginal surgery for POP were randomized to TVT or sham surgery • The rate of UI at 12 months was 27.6% in the TVT group and 43% in the sham group (P=0.002) • 6.3 slings were placed to prevent 1 case of UI at 12 months • UTIs, bleeding complications (3.1%), and voiding disorders (3.7%) were all higher in the TVT group • However, it is still controversial what to do to the bladder neck in women with symptomatic prolapse having vaginal surgery who have no SUI on pre‐operative testing with reduction • Wei JT, et al. N Engl J Med 2012; 366:2358‐2367 53 Occult SUI ‐ Summary Prolapse and no SUI: Using reduction stress test (RST) to decide whether a sling should be done • For a patient with occult SUI having abdominal sacral colpopexy, one may choose Burch if the case is open, and TVT or TOT if it is L/S or Robotic • For prolapse cases with occult SUI done vaginally, best to choose a sling with the highest benefit and lowest risk. Patients are especially intolerant of urinary retention in this setting. • Choose a TOT over a RP TVT in women with occult SUI because there are comparable cure rates for SUI, but less risk of urge and retention. ISD is rare in this poplulation. • Cohort Study: 152 women had laparoscopic sacral colpopexy and followed 4‐21 months • Women with a (‐) RST had sacral colpopexy only; women with a (+) RST had sacral colpopexy + sling • At follow up 18.6% of women in the (‐) RST group had a later sling for de novo SUI • In the (+) RST group 7.3% had voiding difficulties requiring sling revisions • Overall, 88% of patients did not need a second surgery • Park J, et al. Int Urogynecol J 2012; 23:857‐864 Our data May be • For prolapse cases with no occult SUI on pre‐ op testing, one might do a small suburethral plication to try to prevent early denovo SUI (unsupported by evidence) • Consider Mini‐slings • • • • • References • Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 2006; 354:1557‐66 • Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med 2012, 366:2358‐ 67 • UpToDate • Laparoscopic or Robotic Sacrocolpopexy with Tension‐Free Sling to Prevent and Treat Symptomatic or Occult Stress Urinary Incontinence L B Westermann, J Kissling, N Agarwala www.urotodayinternationaljournal.com Volume 5 ‐ April 2012 54 Use of mini‐sling for occult SUI patients No adverse events Less than 5% denovo SUI High patient satisfaction Less OR time, less blood loss and less voiding dysfunction Disclosure Fistulae and Diverticulae I have no financial relationships to disclose. Charles R. Rardin, MD Associate Professor of OB/Gyn Director, Fellowship in Female Pelvic Medicine and Reconstructive Surgery Alpert Medical School of Brown University Director, Minimally Invasive and Robotic Surgical Services Women &Infants Hospital Providence, RI [email protected] Rectovaginal Fistula: Causes Obstetric trauma produces 88% of RVF 50% of women with Crohn’s Disease will develop perianal fistulas; 5-10% will develop RVFs Much lower incidence with Ulcerative Colitis cryptoglandular abscess, Bartholin’s, rectovaginal hematoma, LGV, tuberculosis, Diverticulitis Prior surgery Cancer Radiation – up to 6% 48% preoperative anal incontinence This will be important in selecting treatment options Patients with postoperative AI are unsatisfied despite “success” in RVF repair Tsang CBS, Surg Clinics N Am, 1997 Champagne BJ, Surg Clin N Am 90 (2010) Venkatesh KS, Dis Colon Rectum 1989 Diagnostic Evaluation Vaginal passage of stool, gas, mucopurulent drainage Dyspareunia, pelvic pain or vaginal infections Evaluation of continence status Infection 0.1% of vaginal deliveries in the western world Sub-saharan Africa and Asia: 100,000 new cases annually Inflammatory Bowel Disease Presenting Symptoms Fistulography Examination of vagina, rectum and perineum Vagina instilled with water (+/- soap) to evaluate for air bubbles upon rectal instillation Vaginal tampon with rectal instillation of dye Vaginography (79-100% sensitive) Fistulogram Ultrasound CT with oral contrast MRI Proctoscopy 55 water-soluble dye infused rectally (foley catheter). Fill balloon with air to minimize obscuring distal fistulae alternative: Defecogram with barium/water and thickener, and valsalva Imaging Modalities Modality Predictive Value Contrast Vaginography 79% Contrast Proctography 35% Endoanal Ultrasound 7-73% Imaging – one rationale Comments Endoanal ultrasound with 48-73% H2O2 tract instillation MRI Approaches 100% CT >60% (not evaluated recently) Simple RVF, especially those with anal incontinence – consider transanal ultrasound Complex RVF – consider MRI Commonly part of OB trauma evaluation; evaluates concomitant sphincter injury More accurate than digital, ultrasound or surgical (?) Some instances of mistaking vascular structures as fistula Champagne BJ, Surg Clin N Am 90 (2010 Tsang Classification Treatment options Daniels anatomic descriptions Also considers etiologies Classification of Rectovaginal Fistula Simple •Low or Mid-vaginal Location •Size < 2.5 cm •Trauma or Infection Observation Medical – Crohn’s only Complex •High Vaginal Location •Size ≥ 2.5 cm •IBD, radiation or cancer •Previous failed repairs Obstetric or trauma – some possibility (≤25%) of resolution Cancer, IBD, radiation – little chance cyclosporine, 6-MP, inflimixab Disappointing results in RVF Fibrin Sealant Reported success of up to 74%* Multiple applications may be required Others’ experiences much less optimistic Risk is minimal Tsang CBS, Surg Clinics N Am, 1997 *Hjortrup A, Dis Colon Rectum 1991 Timing of Surgical Repair Principles of Surgery Surgical intervention – allow for tissue healing Historical recommendations of 2-6 months after injury Most level III evidence now allows for earlier repair if no evidence of active inflammation Medical control of proctitis or other inflammatory concerns optimize granulation, infection and edema repair must interrupt continuity of the tract interpose a layer of fresh, vascularized tissue excise the tract, evert the ostial edges 2nd layer closure will reduce the tension on the first layer vaginal side (low pressure side) may be left open to drain DL Nichols, 2000 56 Surgical Treatment: High fistula repair Local Repairs: Layered Closure Usually related to IBD or diverticulitis potential clues passage of liquid stool per vagina with solid stool per rectum excoriation of vagina and vulva due to digestive enzymes Abdominal approach Resection of bowel segment with diseased tissue, primary anastomosis is most successful Endoanal Advancement Flap Local Repairs: Perineoprocotomy A 34-year old primipara whose delivery was complicated by a third-degree perineal laceration, subsequently underwent a layered-closure type surgical repair of a rectovaginal fistula by another surgeon in a different subspecialty. She is dissatisfied with the outcome of the reparative procedure when she presents to you for further evaluation. The most likely cause of her dissatisfaction is: A. B. C. D. Low- or Mid-Level Fistula Local repair Techniques Approach and Technique Success Rate Transvaginal Layered Closure 84-100% Fistula Inversion (Latzko) 73% Transanal Recurrence of the fistula Vulvar asymmetry Failure of the procedure to correct her anal incontinence Frustration with the obstetrical events leading up to her perineal injury Layered Closure 84-100% Advancement Flap 78-100% Transperineal 57 Perineoprocotomy with layered closure 88-100% Sphincteroplasty 78-100% Fistulotomy Not recommended (sphincter disruption, high reoperation rate) Outcomes of Repairs Surgical Approach to Simple RVF 48% of women with obstetrical fistula also reported incontinence prior to repair 65% of those with FI remained incontinent after fistula repair Anal Sphincter Defect (Symptoms or Ultrasound) Normal 100% after flap advancement 48% after sphincter repair Defect 1. Layered Closure 2. Advancement Flap 3. Fistula Inversion Of women with successful repair of fistula 42% were unsatisfied all of those remained incontinent Tsang CBS, Surg Clinics N Am, 1997 Tsang CBS,. Dis Colon Rectum 1998 Temporary Diversion? 1. Transperineal Sphincteroplasty 2. Perineoproctotomy with layered closure Urethral Diverticulae Expert Opinion varies widely Not usually required for primary repair of midlevel or low fistula repair (simple) Exceptions may include: radiation injury severe perineal infection Complex colorectal repairs Failed previous attempts 58 Disclosure I have no financial relationships to disclose. Refractory OAB‐ Interstim and Botox Treatment of Urinary Incontinence Lawrence Lin MD Thousand Oaks, CA 1st line of treatment for OAB Behavioral Therapy 2nd line of treatment: Pharmacologic agents Failed all medical management I. Failed the antimuscarinics 1st line: Failed Behavior therapy • Failed bladder retraining and timed voids • Failed biofeedback • Failed pelvic floor physical therapy ‐ Failed Vesicare, Enablex, Toviaz, Sanctura, Oxytrol, Ditropan etc. II. Failed tricyclic antidepressants ‐ Failed imiprimine III. Failed B3 adrenergic agonist ‐ Myrbetriq (Mirabegron) 3rd line of treatment for OAB Bladder Botox • FDA approved in Jan 2013 • 8 serotypes of Botox: ‐Only Botox “A” FDA approved Specifically, onabotulinumtoxin A 3rd line of treatment: There are 2 options (a) PTNS (Percutaneous Tibial Nerve Stimulator) (b) Bladder Botox A • Causes the bladder muscles to relax to increase the bladder capacity, and decreases UI. • Affects skeletal muscles, yet the bladder is a smooth muscle • Botox is manufactured by Allergan Inc. 59 Mechanism of action: Botox A MECHANISM OF ACTION OF BOTOX A •BOTOX® protein molecule passes through the cell membrane of the motor nerve via endocytosis • Light chain of Botox A binds to the SNAP‐25 receptors on the nerve terminals and cleaves the SNAP 25 receptors. • Thereby, the Acetylcholine vesicle is unable to bind to the nerve terminals and unable to release the ACH at the neuromuscular junction, thereby preventing muscle contractions. •The light chain of the BOTOX protein molecule cleaves apart a protein (called SNAP25) that enables vesicles which store the neurotransmitter acetylcholine to attach to the cell membrane. • Cleaving SNAP25 prevents these vesicles from fusing with the membrane and prevents the release of acetylcholine into the neuromuscular • Thus, nerve impulses that control muscle contractions are blocked decreasing muscle activity. Where to inject Botox A? Indications: Botox A • Avoid the trigone area • Intradetrusor injections Two FDA indications 1. Refractory OAB. 2. Detrusor overactivity associated with a neurological condition (eg spinal cord injury, MS) – Approx 15‐20 injections – Total of 10 ml of Botox (100 units) – 5 injections per row x 3 rows Clinical trials—Botox A Contraindications for Botox A • Two clinical trials of 1,105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo. • Incomplete bladder emptying • No UTI prior to treatment • History of recurrent UTI (2 or more UTI in 6 months) • History of hypersensitivity to any botox preparation • History of pre‐existing Neuromuscular Disorders (eg Myasthenia Gravis) have inc risk of severe dysphagia and respiratory compromise • Results after 12 weeks – Botox pts experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. – Botox‐treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 milliliters more urine than those treated with placebo 60 Adverse reactions: Botox A Safe and effective dose: Botox A • Doses: 100, 150, 200 units • For OAB: ‐ the starting dose should be 100 units (in 10 ml of preservative free 0.9 NS) ‐ Administer 20 injections of 0.5 ml • For NDO (Neurogenic Detrusor Overactivity) ‐ Starting dose is 200 units (30 ml) as 30 injections of 1 ml Common side effects include: • UTI (18%) • Dysuria (9%) • Increased PVR in up to 72% • Incomplete emptying of the bladder (urinary retention) in 6‐20% ‐ Risk of intermittent self catheterization until the urinary retention resolves. Relative contraindication if pt is unwilling to perform self‐cath Recommendations: Repeat dosing for Botox A Pre‐op instructions: Botox A • Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments. • Pre‐treat with lidocaine instillation 20 minutes prior to bladder injections • Pt must be willing to perform CIC (clean intermittent cath) if required • Max cumulative dose should not exceed 360 units in a 3 month interval (eg Botox used on face and other areas) 3rd line of treatment for OAB PTNS Postop instructions: Botox A • Allergan’s antibiotic recommendation are: Percutaneous Tibial Nerve Stimulator ‐ 1‐3 days of pre‐op antibiotics ‐ 1‐3 days of post‐op antibiotics • Immediately post injection, bladder should be drained and then observed in office for 30 min afterwards • Assess PVR in 1‐2 weeks after injection. Risk of incomplete bladder emptying is highest after 1 week • During first 12 weeks post injection, pt will contact your office if difficulties in voiding. • Indications: reducing OAB symptoms in the short and medium term OAB. 61 Risks for PTNS: Overall, minimal risk: • Bleeding or discomfort at the needle site (4%) • ankle bruising and tingling in the leg Contraindications: • Pacemaker or defibrillator Mechanism of action: PTNS • Mechanism of action of PTNS: unclear. But thought to be mediated by retrograde stimulation of the sacral nerve plexus (neuromodulation). • The posterior tibial nerve contains mixed sensory motor nerve fibers. Impulses travel along the tibial nerve to the sacral nerves. • Tibial nerve has input S2,3,& 4 roots Procedure PTNS: •Fine needle is inserted percutaneously just above the ankle, next to the tibial nerve Duration of treatment: PTNS • Initial treatment: 12 outpatient sessions Q weekly, each lasting 30 minutes each, • Further sessions are generally needed for longer‐term relief • A surface electrode is placed on the foot. The needle and electrode are connected to a low‐voltage stimulator. • Stimulation of the posterior tibial nerve produces a typical motor (plantar flexion or fanning of the toes) and sensory (tingling in the ankle, foot or toes) response. Maintenance therapy for PTNS Clinical Study #1: PTNS • Tailored to each pt’s response • Typically once a month • A randomized controlled trial (RCT) of 220 patients treated by – PTNS 55% (60/110) moderate or marked improvement – Sham 21% (23/110) improvement of bladder symptoms of patients respectively at 13‐week follow‐up (p < 0.001) Peters K et al. J Urol 2010. 62 Clinical Study # 2: PTNS Clinical Study # 3: PTNS • An RCT of 100 patients treated by: ‐ PTNS reported that 80% (35/44) improved or cured ‐ Medication: 55% (23/42) of patients considered themselves to be cured or improved after 12 weeks of therapy (p = 0.01) • To compare the clinical efficacy of PTNS to Toerodine –LA for urinary frequency • 12 week treatment • N=100 • 1:1 randomization RESULTS: Similar efficacy PTNS = Detrol LA Peter KM et al. J Urol. 2009 Sep 182 (3): 1055‐61 4th line of treatment OAB: Sacral Neuromodulation (Interstim) Final Conclusion PTNS • Interstim is stimulation of the sacral nerves to reduce the reflexes that influence the bladder, sphincter, and pelvic floor • PTNS is significantly better when compared to placebo. • PTNS is similar in efficacy to Detrol LA • Interstim utilizes mild electrical pulses to improve normal voiding function 4th line of treatment OAB: Sacral Neuromodulation (Interstim) Mechanism of action: Interstim MOA: Direct stimulation of the S3 sacral nerve Objective: Place the tined lead into S3 foramen Two stages: • Stage 1: Trial phase with an external IPG (implantable pulse generator) and a temporary or permanent lead • Stage 2: Permanent lead and IPG placed if trial is successful 63 4th line of treatment OAB: Sacral Neuromodulation (Interstim) Interstim: Placement of lead at S3 foramen 2 approaches I. PNE (Peripheral Nerve Evaluation) approach. Stage I: Placement of a “temporary” lead in the office setting and if successful, then proceed with Stage 2– placement of “permanent” lead and IPG in the OR. II. Staged Approach. Stage I: Placement of “permanent” lead placement in the OR. Stage 2: If successful, return to OR to place IPG Interstim: S3 foramen Stage I Interstim Placement of an external IPG 64 Stage I Stage II Interstim If Stage I is successful (with x>50%) reduction in symptoms, then proceed with implantation of the IPG 65 CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP). US Population Language Spoken at Home California Language Spoken at Home Spanish English Spanish Indo-Euro Asian Other Indo-Euro English Asian Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5% California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm. Executive Order 13166,”Improving Access to Services for Persons with Limited English Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access. Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population. ~ If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538. 66