Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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Sacral nerve modulation (SNM) is an established treatment for refractory lower urinary tract and bowel dysfunction (Spinelli 2008). Pudendal nerve stimulation (PNS) has been proposed for patients failing SNM treatment of urinary dysfunction (Spinelli 2005). In this study SNM and PNS are compared for the treatment of fecal incontinence. In a test phase, both treatments will be applied for one week each in a randomized and blinded order (cross-over design). After the test phase the more successful treatment will be determined and applied permanently. If both treatments are equally sufficient, PNS will be chosen for permanent stimulation, since preliminary data indicate that PNS has a lower power consumption than SNM. Lower power consumption results in a longer lifetime of the stimulator, thus requiring less replacement surgeries.

Detailed Description
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Primary Surgery: Implantation of two electrodes, one placed next to the sacral nerve, one close to the pudendal nerve. Electrode wires are passed through the skin just above the gluteal region and are marked S and P. One of the sub-investigators (not involved in the follow-up) replaces the S and P marks by 1 and 2 marks in absence of the operating surgeon. Assignment of 1 and 2 is carried out in a predefined randomized fashion (computerized block randomization). Test phase: Electrode labeled 1 is connected to a stimulator and the nerve is stimulated for one week, then the other electrode is stimulated for a week. Based on bowel habit diary, Wexner score (Jorge 1993) and subjective experience of the patient, the more successful treatment is chosen. If both electrodes were equally successful, the pudendal nerve electrode will be chosen for permanent stimulation. Secondary surgery: After unblinding, the less effective electrode is removed and the remaining electrode is connected to an implanted stimulator (permanent phase). In case both treatments were unsuccessful, both electrodes are removed.

Official Title
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Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: Sacral nerve modulation
* Procedure: Pudendal nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fecal incontinence nonresponsive to conservative treatment Exclusion Criteria: sacral or perineal infection sphincter defect larger than 60° (sonography) pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacral nerve modulation first<br>Sacral nerve modulation is applied before the pudendal nerve stimulation. There is no wash-out period (pause) between the two treatments. | Procedure: Sacral nerve modulation<br>* For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.<br>* Other names: SNS;Procedure: Pudendal nerve stimulation<br>* For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.<br>* Other names: PNS;|
| Experimental: Pudendal nerve stimulation first<br>Pudendal nerve stimulation is applied before the sacral nerve modulation. There is no wash-out period (pause) between the two treatments. | Procedure: Sacral nerve modulation<br>* For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.<br>* Other names: SNS;Procedure: Pudendal nerve stimulation<br>* For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.<br>* Other names: PNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power consumption of stimulator |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner Score (Jorge 1993) |  | 7, 14 days, 3, 6 & 12 months | 
| Incidence of surgical complications (adverse events) graded according to Dindo (2004) |  | 30 days | 
| Quality of Life (FIQL (Rockwood 2000)) |  | 14 days, 3, 6 & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Incontinence, Colorectal surgery, Sacral nerve stimulation, Pudendal nerve stimulation