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Nerve Stimulation Therapies for Bowel and Bladder Continence R. Keith Huffaker, MD, MBA, FACOG Quillen/ETSU Center for Pelvic Surgery and Urogynecology Disclosures • None Objectives • Sacral nerve stimulation (SNS) – InterStim – Diagnoses • Percutaneous tibial nerve stimulation (PTNS) – Urgent PC – Diagnoses Overactive Bladder: Prevalence & Impact 35 30 25 20 15 10 5 0 OAB 1 OAB Asthma 2 Asthma Diabetes 3 Diabetes Osteoporosis 4 Osteoporosis Alzheimer's 5 Alzheimer’s • It is estimated that overactive bladder (OAB) affects more than • • 33 million people in the U.S.1 OAB is more prevalent than many well-known diseases.2-5 The total U.S. economic cost of OAB is $12.6 billion (year 2000 dollars).6 1. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801. 2. Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010. 3. National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010. 4. National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010. 5. Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010. 6. Hu, TW et al. Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study. Urology.2004;63(3):461-465. Sacral Nerve Stimulation Indications --for urinary control is indicated for the following in patients who have failed or could not tolerate more conservative treatments: Overactive bladder • Symptoms of urinary urge incontinence • Symptoms of urgency-frequency • Combination of both Urinary retention/incomplete emptying • Non-obstructive It’s simply the muscles or the nerves Where Medications Work Efferent messages tell muscles to work. Medication may help muscle comply better Where InterStim works Sensory Messages (Afferent) tell the brain what is happening with the bladder and other voiding components InterStim modulates incorrect messages. InterStim: consider after two medications fail. Unlikely third or fourth will work. Also has some effect on muscles/motor Normal Micturition • Filling: The detrusor muscle is relaxed so that the bladder wall can stretch and fill to capacity. Inhibition (efferent) signals cause the sphincter and pelvic floor to tighten (guarding reflex). • Capacity: Sensory (afferent) receptors in the bladder wall are stimulated, causing a feeling of fullness or discomfort (urge sensation). • Voiding: Under conscious brain control, the external sphincter and pelvic floor relax, while the detrusor muscle contracts (voiding reflex). Mechanism of Action • Mechanism of action for SNS is not fully understood at this time - many theories exist. • Generally agreed that stimulation of the sacral nerves modulates the neural reflexes that influence the bladder, sphincter and pelvic floor that control/influence voiding. (Afferent Reference: Chancellor MB, Chartier-Kastler EJ. Principles of sacral pathways) nerve stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. International Neuromodulation Society 2000; 3: 15-26. Treatment Algorithm to Evaluate for InterStim Therapy Urinary Urgency-Frequency and Urge Incontinence Initial Screening Voiding Diary Urodynamic Work-up Behavioral Techniques Interventional Techniques Medications + Continue as Appropriate InterStim Therapy Test Stimulation Treatment Algorithm to Evaluate for InterStim Therapy Urinary Retention Initial Screening Voiding Diary Urodynamic Work-up Rule Out Obstruction Medications and/or Catheterization + Continue as Appropriate InterStim Therapy Test Stimulation InterStim Pre-test Requirements • Patient has had condition for > 1 year • Stress incontinence has been eliminated as major urinary complaint • Patient failed conventional therapy: – Behavior modifications – Two medication failures – Cannot comply with other treatment option (I.e. selfcath) • Can complete urinary diary and use device • Patient has improvement of 50% or > during test • Therapy consists of 2 steps: 1. Test stimulation procedure – allows trial of InterStim Therapy -simple (30-45) minutes -done in office (PNE) or outpatient room (PNE or Stage I) --test for a ½ to 1 week -percutaneous wire -external pulse generator -voiding diary 2. Implantation of device --full implant --Stage II --both steps target S3 foramen and nerves Test Stimulation: Place the Temporary Test Lead Click for video. Lead parallel to nerve Relate Sacral Anatomy to Lead Location Look for Motor and Sensory Responses Connect the Lead to External Test Stimulator When desired responses are achieved, the lead is secured and connected to an external test stimulator Discuss: • Antibiotics • Anesthesia • Dressing technique • Documenting lead location Implant Procedure • Patients with a successful test stimulation go on to implantation of the internal pulse generator. (50%) • A pocket is typically created for the neurostimulator in the upper buttock. Complete InterStim System 1. Tined lead is placed parallel to the sacral (S2, S3, or S4) nerve. 3 2. Implantable 2 2 neurostimulator generates mild electrical pulses that are delivered through the lead electrodes. 3. Clinician and patient 1 programmers are used to set the parameters of the electrical pulses. Estimated Battery Life High, Moderate, and Low Energy Consumption • These estimations of battery life assume a new neurostimulator with no subsequent adjustments to stimulation parameters. • Battery life will be shortened if stimulation parameters are increased to consume more energy. • Accurate placement of the InterStim lead will minimize stimulation parameters and energy consumption, thus maximizing battery life. InterStim Delivers Clinical Efficacy 1 12-month clinical success for Urinary Control 79% of urge incontinence patients achieved clinical success • 45% remained completely dry • An additional 34% experienced 50% reduction in leaking 64% of urgency-frequency patients achieved clinical success Urge Incontinence UrgencyFrequency Urinary Retention (n=38) (n=33) (n=38) 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011. • 31% returned to normal voids (4 to 7 voids/day) • An additional 33% experienced 50% reduction in number of voids 77% of urinary retention patients achieved clinical success • 61% eliminated use of catheters • An additional 16% experienced 50% reduction in catheterized urine volume InterStim Therapy for Urinary Control Lasting Efficacy - Proven in a 5-year Clinical Trial Urge Incontinence1 Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline • 59% of urge incontinent patients achieved 50% reduction in leaks/day* • 71% of those urge incontinent patients who reported heavy leaks at baseline achieved 50% reduction in leaks per day† * 59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96) † 71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84) 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011. InterStim Therapy for Urinary Control Lasting Efficacy - Proven in a 5-year Clinical Trial Urinary Retention1 Evaluable Patients – the subset of subjects for whom both baseline and 5-year data were available Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline 78% of urinary retention patients achieved 50% reduction in volume/catheterization* * 78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31) 1. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011. Sacral Nerve Stimulation Indications Also indicated for the treatment of Chronic Fecal Incontinence in patients who have failed or are not candidates for more conservative treatments. Fecal IncontinenceMore Common Than You Might Think 35 30 25 20 15 10 5 0 OAB1,2 OAB Asthma 3 Asthma Diabetes 4 Diabetes FI 5 FI Osteoporosis 6 Osteoporosis Alzheimer's 7 Alzheimer’s • It is estimated that more than 18 million adults in the United States • – 1 in 12 – suffer from fecal incontinence (FI)5 FI is nearly as prevalent as many other chronic diseases and more prevalent than other illnesses well-known to impact many Americans.1-4,6-7 Stewart, W.F et al. Prevalence and Burden of Overactive Bladder in the United States.World Jrnl of Urol 2003:20:327-336 Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):791-801. Centers for Disease Control and Prevention Website. http://www.cdc.gov/asthma/brfss/03/lifetime/tableL1.htm. Accessed October 18, 2010. National Diabetes Information Clearinghouse Website. http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people. Accessed October 18, 2010. 5. Whitehead W.E. et al. Fecal Incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009; 137:512-517. 6. National Osteoporosis Foundation Website. http://www.nof.org/node/40. Accessed October 18, 2010. 7. Alzheimer’s Association Website. http://www.alz.org/alzheimers_disease_facts_figures.asp. Accessed October 18, 2010. 1. 2. 3. 4. Patient Education Needed Studies suggest that only 15%– 45% of FI patients seek treatment1,2. Consider the following statistics that support the claim that fecal incontinence is a hidden condition: • For 84% of patients with FI, the physician was unaware of the patient’s • • disorder1 54% of patients with FI had not discussed the problem with a professional2 65% of patients with severe or major FI which had an impact on the quality of life wanted help with their symptoms3 1. Damon H, Guye O, Seigneurin A, et al. Prevalence of anal incontinence in adults and impact on quality-of-life. Gastroenterol Clin Biol. 2006;30(1):37-43 2. Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing. 2001;30(6):503-7 3. Perry S, Shaw C, McGrother C, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut. 2002;50(4):480-484. FI Impacts Quality of Life Fecal Incontinence Quality of Life Scale (FIQOL) Scores Note: Higher scores translate to higher quality of life Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P080025. Treatment Algorithm to Evaluate InterStim Therapy Chronic Fecal Incontinence InterStim Therapy for Bowel Control Percent of Patients with a 100% Reduction in Accidents at 12 Months Clinical Efficacy: Complete Continence InterStim Therapy Bowel Control Study1,2 Tjandra RCT3 47% 41% 36% MWC (n=120) Per‐protocol (n=106) SNS group (n=53) 1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 2. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011. 3. Tjandra JJ et al. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. May 2008;51(5):494-502. FIQOL ― Improvement in Quality of Life InterStim Therapy for Bowel Control n = 120, p < 0.0001 MWC analysis Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2010 InterStim Therapy for Bowel Control Clinical Efficacy: Quality of Life InterStim Therapy Bowel Control Study1 Mean FIQOL Score (Com pleters Analysis) 4.0 3.5 3.0 2.5 2.0 1.5 1.0 Baseline (n=119) 3-Months (n=116) 6-Months (n=109) 12-Months (n=107) 24-Months (n=68) 36-Months (n=30) Scale 1 - Lifestyle 2.31 3.22 3.26 3.36 3.32 3.52 Scale 2 - Coping/Behavior 1.49 2.64 2.69 2.77 2.69 2.7 Scale 3 - Depression/SelfPerception 2.53 3.33 3.48 3.54 3.58 3.77 Scale 4 - Embarrassment 1.6 2.73 2.75 2.81 2.76 2.95 1. Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. Mar 2010;251(3):441-449. Sacral Neuromodulation Therapy for Bowel Control Prospective Clinical Study • Prospective, multicenter study – Primary endpoint was a >50% reduction in incontinence episodes per week – 133 subjects underwent test stimulation • 90% had a successful test trial – 12 month follow-up: • 83% success • 41% complete continence 1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 2. InterStim Therapy Clinical Summary, 2011. Fecal Incontinence, Tjandra study • Prospective randomized trial of SNM vs. optimal medical management in patients with severe fecal incontinence • SNM (n=60) • Optimal medical management (n=60) – pelvic floor exercises, bulking agent, and dietary manipulation. • Assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502. Tjandra Study ― Safety Results The most common adverse events (≥5.0%) reported are: • Excessive tingling in the vaginal region = 9% • Implant site pain, especially in slimmer patients = 6% Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502. Fecal Incontinence, Tjandra study • Follow-up at 12 months • Two groups similar with demographics and severity of symptoms • SNM group – 90% successful stage 1 – Mean weekly incontinent episodes from 9.5 to 3.1 – Mean incontinent days/week 3.3 to 1 • Significant improvement in fecal incontinence QOL index in all four domains in SNM group • No improvement in the medical management group Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502. Chan and Tjandra. Sacral Nerve Stimulation for Fecal Incontinence: External Anal Sphincter Defect vs. Intact Anal Sphincter. Diseases of the Colon and Rectum:2008. • Prospective study • External anal sphincter defect, n=21 • External anal sphincter intact, n=32 • 3,6,12mo f/u – Anorectal physiology – Wexner’s score – Bowel diary – QOL Q’s • All 53 benefited from SNS • EAS defects: Weekly incont. episodes decreased from 13.8 to 5 at 12 mos. • EAS intact 6.7 to 2 • QOL scores improved for both groups • +/- pudendal neuropathy irrelevant • Size of EAS defect did not matter up to 120 degrees LeRoi, et al. Efficacy of Sacral Nerve Stimulation for Fecal Incontinence Results of a Multicenter Double-Blind Crossover Study. Annals of Surgery:2005. • n=27 (most were women) • SNS implanted • Double-blind crossover design • Randomized to on or off for one month periods • Pt then chose the period of preference not knowing whether was actually on or off • Placed in preferred mode for 3 months • On group preferential Interstim Bottom Line • Interstim is FDA approved for – – – – – refractory urgency and frequency urge incontinence incomplete bladder emptying fecal incontinence Not for pain (PBS/BPS/IC) • Effective therapy with intermediate long• term follow-up. Support is critical What is PTNS? • Defined in a variety of ways: – Percutaneous Tibial Nerve Stimulation – Posterior Tibial Nerve Stimulation – Posterior Tibial Neurostimulation • Example: New CPT® code 64566 “Posterior tibial neurostimulation - percutaneous electrode, single treatment, includes programming” Potential PTNS Patients PTNS • Easy to administer in twelve 30 minute sessions with maintenance therapy variable • Effective – Approximately 2/3 of patients report a reduction in their symptoms • May work even if other treatments have failed • Low risk – Most common side-effects include transient mild pain or skin inflammation at or near the stimulation site Treatment with PTNS • Stimulation • Provides Percutaneous Tibial Nerve Stimulation (PTNS) delivered via a 34 ga. needle electrode • Needle electrode inserted above medial malleolus • The needle electrode is connected to a battery-powered stimulator PTNS Neuromodulation System Treatment with PTNS • Impulse travels from the ankle along the tibial nerve to the S2, 3, and 4 Office-based Treatment • Patient is clothed and comfortable • May be administered by qualified staff, under physician supervision • Physician and staff can treat multiple patients at once Treatment Frequency • 12 weekly PTNS treatments • Responders may need maintenance treatments to sustain improvements – Slowly increase time between treatments – If symptoms reappear or increase in severity, return to last frequency to sustain relief – In OrBIT study, treatment interval increased to 24 days between treatments during months 6 – 12 PTNS Contraindications • Patients who are pregnant or planning to become • • • • • • pregnant while using this product Patients with pacemakers or implantable defibrillators Patients prone to excessive bleeding Patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function Not intended for intra-cardiac or trans-thoracic use Concurrent use of medical monitoring equipment during stimulation is not recommended Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide PTNS Clinical Effectiveness • 30+ peer reviewed publications demonstrate safety and efficacy – Reduce urgency, urge incontinence & frequency – Significant objective and subjective improvements – No serious adverse events or side-effects – Improved quality of life – Objective urodynamic data – 2/3 of patients respond well PTNS Studies • Payne 1998, Freq & Incont, N=98, 80% improved • Vandoninck 2003, OAB, N=90, Freq 1310, incontinence 5-2/day • Vandoninck 2003, Urge incontinence, N=35, 16/35 dry, pads/nocturia/HRQOL all improved • Congregado-Ruiz 2004, OAB and UI, N=51, all parameters stats improved • De Dennaro 2004, OAB, N=23, 80% improved • Peters, et al. • J Urol 2010 • N = 220 • 52% PTNS & 57% Sham correctly guessed intervention • PTNS pts showed significant improvements: urgency, frequency, UI, sx severity, QOL measures Meta-Analysis of 7 PTNS Studies Martinson, M. (2008). Meta-Analysis of PTNS for Urinary Disorders. Sponsored by Uroplasty, Inc. 60 – 80% Response MacDiarmid, S., & Staskin, D. (2009). PTNS: A literature based assessment . Curr Bladder Dys , 4, 29-33. OrBIT – PTNS vs. Detrol® LA • Multicenter, RCT • 12 week phase • 12 month responder follow-up • 1:1 randomization (n=100) • Physician and patient GRA • Voiding diaries, QoL measures PTNS compared to Drug • Patient perception of cure/improvement: • • • 80% in PTNS group; 55% in tolterodine LA group Physician perception of cure/improvement: 80% in PTNS group; 61% of tolterodine LA group Comparable reductions in voiding episodes and urge incontinence Side-effects: No serious adverse events were associated with either treatment. Constipation and dry mouth reported more often in tolterodine LA group Peters, K.M., Leong, F.C., Shobeiri, S.A., MacDiarmid, S.A., Rovner, E.S., Wooldridge, L.S., et al. (2008). Randomized multicenter study comparing percutaneous tibial nerve stimulation with pharmaceutical therapy for the treatment of overactive bladder. Abstract, American Urologic Association, Annual Meeting, Orlando, FL. OrBIT Results – Long-term • Statistically significant improvement sustained from 12 weeks thru 12 months • – Frequency -2.8 voids/day (p<0.001) – Nighttime voids -0.8 voids/night (p<0.05) – Urgency -3.7/day (p<0.01) – Voided volume +39 cc (p<0.05) – Incontinence episodes -1.6/day (p<0.001) – QOL measure (p<0.01) No serious adverse events or device malfunctions OrBIT – Side Effects • Constipation reported less often in PTNS arm compared to drug arm (p=0.04) • Dry mouth reported less often in PTNS arm compared to drug arm (p=0.0004) • PTNS group reported pain, discomfort or redness at ankle (assessed for PTNS group only) PTNS Long-Term Follow-up • Retrospective analysis of 256 patients (178 were • • • treated for OAB symptoms) Sixty percent (107/178) of patients with OAB symptoms were responders Results stable at three-year mean follow-up when initial series was followed by maintenance therapy Only 10% of patients showed significant reduction of the obtained results Cappellano F., Finazzi Agro E., Giollo A., Petta F., Catanzaro M., Miano R., Germani S., Catanzaro F. (2006). Percutaneous tibial nerve stimulation (PTNS): results at long term follow-up. Abstract presented at the SIUD Congresso Nationale 2006, 2730 September, Rome, Italy. Risks of Treatment • The risks of PTNS are low • Side-effects include: – Transient moderate pain at or near the stimulation site – Transient mild pain or skin inflammation at or near the stimulation site – Transient mild bleeding at needle insertion site What’s Next for PTNS • Shorter therapy protocols • Determination of prolonged treatment protocols • Fecal urgency and incontinence • Constipation • Incomplete bladder emptying • Chronic pelvic pain • Chronic non-bacterial prostatitis pain • Pediatric use for LUTS