Download Surgical Treatment of Urge Incontinence

Neuromodulation
for Genito-Urinary Disorders
Steven W. Siegel, MD
Centers for Continence Care
and Female Urology
Metropolitan Urologic Specialists
Saint Paul, Minnesota
1
Disclosure
– Medtronic, AMS, Uroplasty, Allergan
• Consultant, lecturer, proctor, grant/research support
– Medical Advisor, Board Member or Equity Partner
• Uroplasty, Allergan, GT Medical, QIG
– Off Label Usage:
• Interstim for pelvic pain, neurogenic disorders
• BoNT for OAB
Neuromodulation in Urology
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•
•
•
Sacral (InterStim)
Tibial (Urgent PC)
Spinal (VoCare)
Chemodenervation (Botox)
Neuromodulation for GU
Disorders
• Refractory OAB
– Failed drugs and behavioral therapy
• Urinary Retention
– Idiopathic non-obstructive
• Non-neurogenic etiology
• Fecal Incontinence
Current treatments for
Overactive Bladder
•
•
•
•
Behavioral therapies & Physical Therapy
Drugs, anitcholinergic
Intravesical Botox
Neuromodulation
– Sacral
– PTNS
• Surgery
– Augmentaton cystoplasty
– Urinary diversion
How Likely Are Patients To Continue
With Their Drug Therapy?
Prescription persistency rates of OAB medications
among patients new to market (n=21,362)
• 56% of patients chose not to refill their prescription a second time
• Only 15% of patient continued with their therapy through the first year
History of
Sacral Neuromodulation
1981
1994
1997
1999
2002
2002
2006
2011
Tanagho and Schmidt UCSF
European CE Mark
FDA approves for Urge Incontinence
FDA approves for UF and NOUR
FDA approves for OAB
Wide use of fluoro, staged implant/tined lead
Small stimulator
FDA approval for bowel indication
(in 1,000s)
Number of Patients
InterStim Therapy Cumulative Use Worldwide
Technique Change – 2002
Percutaneous Tined Lead Placement
100,000 patients have received InterStim Therapy
Additional SNM Applications
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•
•
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Pediatric patients/Dysfunctional elimination syndrome
IC/Pelvic pain
Bowel Dysfunction
Present indications*
» Fecal incontinence
» Fecal urgency-frequency (IBS)
» Idiopathic chronic constipation
– Many patients have both GU/GI symptoms
– Often GI improvements most meaningful to patients
Siegel S, JOU 2001
Comiter C, JOU 2003
Feler C, Anesth Clin NA 2003
Peters K, BJU 2004
Everaert K, Eur Urol 2004
Hoebeke P, JOU 2004
De Gennaro M, JOU 2004
Humphreys M, JOU 2006
Roth abstract 823, AUA 2007
Mechanism of Action
• Not a bladder specific therapy
• Central afferent modulation
– Targets reflex centers in cord and pons
• Treats both OAB and retention
– Blocks ascending sensory pathway inputs
• Turns on voiding reflexes by suppressing
the guarding reflex pathways
• ‘Human Software’ Analogy
Leng WW - Urol Clin North Am - 01-FEB-2005; 32(1): 11-8
Peripheral Neuroanatomy
• Parasympathetic
– S2 – S4 afferent and efferent (Pelvic Nerve)
– Excites bladder, inhibits urethra
• Sympathetic
– T12 – L1 afferent and efferent (Hypogastric Nerve)
– Excites urethra, inhibits bladder
• Somatic
– S2 – S4 afferent and efferent (Pudendal Nerve)
– Excites external urethral sphincter
Pelvic Floor Innervation Schematic
OAB Response (ITT and As Treated)
S3, S4
Pudendal N
Dorsal
Genital N
Targets
Anatomy: Sacral Canal
Relate Sacral Anatomy to Lead Location
Posterior Sacrum
Lateral Sacrum
Trial Stimulation: PNE
• Insulated Needle with
exposed tip placed at S3
– nerve location & function
• Sensory Response
– Genital/anal sensation
– Patient comfort
• Motor Response
– Bellows & toe
Trial Period Criteria
Success equals >
50% improvement
• number of leaks/day
• number of voids/day
• voided volume/void
• degree of urgency
Implantable Pulse Generator IPG
Implantation
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•
•
•
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Based on success of trial
Outpatient procedure under local/sedation
Patient unchanged if therapy denied/discontinued
Can modulate stimulation parameters externally
Permanent devices last up to 10 years (Interstim I)
Patient Selection
• Abnormal Voiding
– May include other symptoms
• Pain
• Bowel dysfunction
• Younger (typical age 45-55)
• Non-neurogenic
• High tone pelvic floor muscle
dysfunction
Poor Candidates for SNM
• Nerve damage
– Peripheral neuropathy
– Future need for MRI
• Pelvic malignancy
• Intrinsic abnormality of bladder
– XRT
– Fibrosis
– Decompensation
• Pain without voiding complaints
• Very elderly
SNM: Clinical Efficacy
Urge Incontinence1
45% completely dry
34% experienced > 50% reduction in
leaking episodes
Urgency Frequency2
31% returned to normal voids (4 to 7
voids/day)
33% experienced > 50% reduction in
voids
Retention3
61% eliminated use of catheters
16% experienced > 50% amount of
urine emptied from catheter usage
N=38
N=33
N=38
SNS Study Group 1JOU 1999;162 ,2JOU 2000;163, 3JOU 2001;165
Systematic Review: Urge Incontinence
Randomized Controlled Trials vs. Case Series Reports
% of patients achieving continence or
> 50% improvement in their symptoms
 Investigation of 1,827
implants from 34 clinical
trials
 SNM shown to be effective
for the treatment of urinary
urge incontinence1
•
Brazelli, M. et al. Efficacy & Safety of Sacral Nerve Stimulation for the Treatment of Urinary Urge
Incontinence: A Systematic Review. Journal of Urology. Vol. 175 835-841, Mar. 2006
Results of a prospective, randomized, multicenter
study evaluating the safety and efficacy of InterStim
Therapy at 6-month follow-up in subjects with
symptoms of overactive bladder
Urge Incontinence
Frequency-Urgency
Siegel, et al AUGS 2012
Urgency-Frequency
Improvement in Quality of Life, 6-Month SF-36 Scores
% of Patients
100
75
50
25
0
PF - Physical Functioning BP - Bodily Pain
RP - Role Physical
GH - General Health
V - Vitality
RE - Role Emotional
SF - Social Functioning MH - Mental Health
PF
RP
BP
GH
V
SF
RE
MH
P < 0.0001P = 0.01 P = 0.01P = 0.003P = 0.01P = 0.002P = 0.17 P = 0.01
Control (n=20)
Implant (n=23)
US Norm
Janknegt RA, Hassouna MM, Siegel SW, Schmidt RA, Gajewski JB, Rivas DA: Patient satisfaction and complications following sacral nerve stimulation for urinary
retention, urge incontinence and perineal pain: A multicenter evaluation. Int Urogynaecol J, 11: 231, 2000
Five year results of SNM for voiding dysfunction:
Outcomes of a prospective, worldwide clinical study
• 17 centers
– 163 patients, mean age 44.7, 87% females
• Success rate 5 years post implant
– 68% UI
– 56% UF
– 71% Retention
• If success at 1 year, rate of success at 5 years
– 89% UI
– 71% UF
– 78% Retention
Van Kerrebroeck et al, JOU 2007
Complications
• Reoperation rate <20%
– Loss of efficacy
– Pain at lead or IPG site
– Infection
* Starkman, NUU 2007; van Voskuilen, BJU 2007; Kessler, Eur. Urol 2006
How Should We Treat OAB
Patients?
BoNT, Other surgery
PTNS, SNM
Drugs
PFM Rehab
Behavioral
Discussion