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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.

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Presentation on theme: "Nerve Stimulation Therapies for Bowel and Bladder Continence R. Keith Huffaker, MD, MBA, FACOG Quillen/ETSU Center for Pelvic Surgery and Urogynecology."— Presentation transcript:

1 Nerve Stimulation Therapies for Bowel and Bladder Continence R. Keith Huffaker, MD, MBA, FACOG Quillen/ETSU Center for Pelvic Surgery and Urogynecology

2 Objectives Sacral nerve stimulation (SNS) Sacral nerve stimulation (SNS) –InterStim –Diagnoses Percutaneous tibial nerve stimulation (PTNS) Percutaneous tibial nerve stimulation (PTNS) –Urgent PC –Diagnoses

3 Where do InterStim and Urgent PC fit?

4 Interstim – Sacral Neuromodulation Indications Urinary Frequency Urinary Frequency Urinary Urgency Urinary Urgency Urge Urinary Incontinence Urge Urinary Incontinence Urinary Retention / Incomplete Bladder Emptying Urinary Retention / Incomplete Bladder Emptying Fecal Incontinence Fecal Incontinence Not for SUI Not for SUI

5 Micturition and Storage Reflexes Leng & Chancellor UNA 2005

6 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. Also has some effect on muscles/motor InterStim: consider after two medications fail. Unlikely third or fourth will work.

7 InterStim Pre-test Requirements Patient has had condition for > 1 year Patient has had condition for > 1 year Stress incontinence has been eliminated as major urinary complaint Stress incontinence has been eliminated as major urinary complaint Patient failed conventional therapy: Patient failed conventional therapy: –Behavior modifications –Two medication failures –Cannot comply with other treatment option (I.e. self- cath) Can complete urinary diary and use device Can complete urinary diary and use device Patient has improvement of 50% or > during test Patient has improvement of 50% or > during test

8 Mechanism of Action Mechanism of action for SNS is not fully understood at this time - many theories exist. 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 pathways) 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 pathways) Reference: Chancellor MB, Chartier-Kastler EJ. Principles of sacral nerve stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. International Neuromodulation Society 2000; 3:

9 But is it really doing anything? Dasgupta and Fowler. Changes in brain activity following sacral neuromodulation for urinary retention.J Urol Dec;174(6): Dasgupta and Fowler. Changes in brain activity following sacral neuromodulation for urinary retention.J Urol Dec;174(6):

10 Therapy consists of 2 steps: 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

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12 After Test Procedure Voiding diary Voiding diary –50% improvement required for implantation –Implantation is not required if you choose not to do so Second step Second step –PNE wires removed in office, or –OR for staged approach Place neurostimulator Place neurostimulator Remove lead Remove lead

13 Implant Procedure Patients with a successful test stimulation go on to implantation of the internal pulse generator. (50%) 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. A pocket is typically created for the neurostimulator in the upper buttock.

14 Tined Lead

15 Patient Programmer Physician Programmer

16 Clinical Study Overview Multi-center randomized, prospective study * Multi-center randomized, prospective study * –23 centers: 9 European & 14 North American –581 patients (1993 – 1998) Measurements: Measurements: –Urge incontinence Number of leaking episodes /day Number of leaking episodes /day Severity of leaking episodes Severity of leaking episodes Number of pads/diapers replaced/day Number of pads/diapers replaced/day –Urgency-frequency Number of voids/day Number of voids/day Volume voided/void Volume voided/void Degree of urgency prior to void Degree of urgency prior to void –Retention Volume per catheterization Volume per catheterization * Staged Implant was not performed during this study

17 Efficacy: Overactive Bladder

18 Efficacy: Urinary Retention

19 Implantation: Ranking of Adverse Events in First 12 Months Post-implant Pain at neurostimulator site15.3% Pain at neurostimulator site15.3% New pain9.0% New pain9.0% Suspected lead migration8.4% Suspected lead migration8.4% Infection6.1% Infection6.1% Transient electric shock5.5% Transient electric shock5.5% Pain at lead site5.4% Pain at lead site5.4% Adverse change in bowel function3.0% Adverse change in bowel function3.0% Note: Additional events occurred – each less than 2.0%

20 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 Prospective study External anal sphincter defect, n=21 External anal sphincter defect, n=21 External anal sphincter intact, n=32 External anal sphincter intact, n=32 3,6,12mo f/u 3,6,12mo f/u –Anorectal physiology –Wexner’s score –Bowel diary –QOL Q’s

21 All 53 benefited from SNS All 53 benefited from SNS EAS defects: Weekly incont. episodes decreased from 13.8 to 5 at 12 mos. EAS defects: Weekly incont. episodes decreased from 13.8 to 5 at 12 mos. EAS intact 6.7 to 2 EAS intact 6.7 to 2 QOL scores improved for both groups QOL scores improved for both groups +/- pudendal neuropathy irrelevant +/- pudendal neuropathy irrelevant Size of EAS defect did not matter up to 120 degrees Size of EAS defect did not matter up to 120 degrees

22 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) n=27 (most were women) SNS implanted SNS implanted Double-blind crossover design Double-blind crossover design Randomized to on or off for one month periods Randomized to on or off for one month periods Pt then chose the period of preference not knowing whether was actually on or off Pt then chose the period of preference not knowing whether was actually on or off Placed in preferred mode for 3 months Placed in preferred mode for 3 months

23 Outcome measures Outcome measures –FI –Fecal urgency –Delay in postponing defecation –Manometry –QOL –Etc.

24 Significant improvement in all when on Significant improvement in all when on Clinical benefit not due to placebo Clinical benefit not due to placebo

25 DiagnosisProcedureSuccessImplantImplant success IESNS PNENo NA IESNS PNENo NA UUISNS PNEYesNoNA IE and UUISNS PNEYes UUISNS PNEYes UUI and FISNS PNEYes UUISNS PNEYes UUISNS PNEYes IESNS PNENo NA IE and UUISNS PNEYes UUISNS PNEYes UUISNS PNEYes IE and UUISNS PNEYes UUISNS PNEYes IE and MUISNS PNEYes UUI and FISNS PNEYes MUISNS PNEYes IE and FISNS PNEYes UUISNS PNEYes IE and UUISNS PNEYes RKH SNS Results IE=incomplete bladder emptying; UUI=urge urinary incontinence; FI=fecal incontinence; MUI=mixed urinary incontinence

26 Interstim Bottom Line Interstim is FDA approved for 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. Effective therapy with intermediate long- term follow-up. Support is critical Support is critical

27 An Option Between Conservative and Surgical Treatments Simple, Office-based Neuromodulation with Urgent® PC Urgent ® PC

28 What is PTNS? Defined in a variety of ways: Defined in a variety of ways: –Percutaneous Tibial Nerve Stimulation –Posterior Tibial Nerve Stimulation –Posterior Tibial Neurostimulation Example: New CPT® code “Posterior tibial neurostimulation - percutaneous electrode, single treatment, includes programming” Example: New CPT® code “Posterior tibial neurostimulation - percutaneous electrode, single treatment, includes programming”

29 Potential Urgent PC Patients

30 Urgent ® PC Easy to administer in twelve 30 minute sessions with maintenance therapy variable Easy to administer in twelve 30 minute sessions with maintenance therapy variable Effective – Approximately 2/3 of patients report a reduction in their symptoms Effective – Approximately 2/3 of patients report a reduction in their symptoms May work even if other treatments have failed 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 Low risk – Most common side-effects include transient mild pain or skin inflammation at or near the stimulation site

31 Treatment with Urgent ® PC Stimulation delivered via a 34 ga. needle electrode Stimulation delivered via a 34 ga. needle electrode Needle electrode inserted above medial malleolus Needle electrode inserted above medial malleolus The needle electrode is connected to a battery-powered stimulator The needle electrode is connected to a battery-powered stimulator Provides Percutaneous Tibial Nerve Stimulation (PTNS)

32 Treatment with Urgent ® PC Impulse travels from the ankle along the tibial nerve to the sacral nerves Impulse travels from the ankle along the tibial nerve to the sacral nerves

33 Urgent ® PC Neuromodulation System

34 Office-based Treatment Patient is clothed and comfortable Patient is clothed and comfortable May be administered by qualified staff, under physician supervision May be administered by qualified staff, under physician supervision Physician and staff can treat multiple patients at once Physician and staff can treat multiple patients at once

35 Treatment Frequency 12 weekly Urgent PC treatments 12 weekly Urgent PC treatments Responders may need maintenance treatments to sustain improvements 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

36 Urgent PC Contraindications Patients who are pregnant or planning to become pregnant while using this product Patients who are pregnant or planning to become pregnant while using this product Patients with pacemakers or implantable defibrillators Patients with pacemakers or implantable defibrillators Patients prone to excessive bleeding Patients prone to excessive bleeding Patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function Patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function Not intended for intra-cardiac or trans-thoracic use Not intended for intra-cardiac or trans-thoracic use Concurrent use of medical monitoring equipment during stimulation is not recommended 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 Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

37 PTNS Clinical Effectiveness 30+ peer reviewed publications demonstrate safety and efficacy 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

38 Meta-Analysis of 7 PTNS Studies Martinson, M. (2008). Meta-Analysis of PTNS for Urinary Disorders. Sponsored by Uroplasty, Inc.

39 60 – 80% Response 60 – 80% Response MacDiarmid, S., & Staskin, D. (2009). PTNS: A literature based assessment. Curr Bladder Dys, 4,

40 PTNS compared to Drug Patient perception of cure/improvement: 80% in PTNS group; 55% in tolterodine LA group 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 Physician perception of cure/improvement: 80% in PTNS group; 61% of tolterodine LA group Comparable reductions in voiding episodes and urge incontinence 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 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.

41 PTNS Long-Term Follow-up Retrospective analysis of 256 patients (178 were treated for OAB symptoms) Retrospective analysis of 256 patients (178 were treated for OAB symptoms) Sixty percent (107/178) of patients with OAB symptoms were responders 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 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 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, September, Rome, Italy.

42 OrBIT – UPC vs. Detrol ® LA Multicenter, RCT Multicenter, RCT 12 week phase 12 week phase 12 month responder follow-up 12 month responder follow-up 1:1 randomization (n=100) 1:1 randomization (n=100) Physician and patient GRA Physician and patient GRA Voiding diaries, QoL measures Voiding diaries, QoL measures

43 OrBIT Results at 12 Weeks

44 *p-value: 0.053

45 OrBIT – Side Effects Constipation reported less often in PTNS arm compared to drug arm (p=0.04) 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) 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 group reported pain, discomfort or redness at ankle (assessed for PTNS group only)

46 OrBIT Results – Long-term Statistically significant improvement sustained from 12 weeks thru 12 months 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 No serious adverse events or device malfunctions

47 OrBIT Results – Long-term Responders continued treatment Responders continued treatment –90% for 6 months –73% for 12 months Sustained improvements at 12 months Sustained improvements at 12 months

48 OrBIT – Treatment Interval

49 Risks of Treatment The risks of Urgent PC are low The risks of Urgent PC are low Side-effects include: 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

50 DiagnosisProcedureSuccess UUIPTNSYes UUIPTNSYes RKH PTNS Results n=2; both successful

51 What’s Next for PTNS Shorter therapy protocols Shorter therapy protocols Determination of prolonged treatment protocols Determination of prolonged treatment protocols Fecal urgency and incontinence Fecal urgency and incontinence Constipation Constipation Incomplete bladder emptying Incomplete bladder emptying Chronic pelvic pain Chronic pelvic pain Chronic non-bacterial prostatitis pain Chronic non-bacterial prostatitis pain Pediatric use for LUTS Pediatric use for LUTS


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