Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence
This study is currently recruiting participants.
Verified May 2013 by Cantonal Hospital of St. Gallen
Sponsor:
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
Lukas Marti, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01069016
First received: February 11, 2010
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fecal Incontinence |
Procedure: Sacral nerve modulation Procedure: Pudendal nerve stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence |
Resource links provided by NLM:
Further study details as provided by Cantonal Hospital of St. Gallen:
Primary Outcome Measures:
- Power consumption of stimulator [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Wexner Score (Jorge 1993) [ Time Frame: 7, 14 days, 3, 6 & 12 months ] [ Designated as safety issue: No ]
- Incidence of surgical complications (adverse events) graded according to Dindo (2004) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Quality of Life (FIQL (Rockwood 2000)) [ Time Frame: 14 days, 3, 6 & 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sacral nerve modulation first
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
For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
Other Names:
Procedure: Pudendal nerve stimulation
For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
Other Name: PNS
|
|
Experimental: Pudendal nerve stimulation first
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
For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
Other Names:
Procedure: Pudendal nerve stimulation
For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
Other Name: PNS
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- fecal incontinence nonresponsive to conservative treatment
Exclusion Criteria:
- sacral or perineal infection
- sphincter defect larger than 60° (sonography)
- pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069016
Contacts
| Contact: Lukas Marti, MD | +41 71 494 1111 | lukas.marti@kssg.ch |
| Contact: Patrick Folie, MD | patrick.folie@kssg.ch |
Locations
| Switzerland | |
| Department of Surgey, Cantonal Hospital St. Gallen | Recruiting |
| St.Gallen, Switzerland, 9007 | |
| Principal Investigator: Lukas Marti, MD | |
| Sub-Investigator: Christine Maurus, MD | |
| Sub-Investigator: Patrick Folie, MD | |
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
| Principal Investigator: | Lukas Marti, MD | Dep. of Surgery, Cantonal Hospital St. Gallen |
More Information
Additional Information:
Publications:
| Responsible Party: | Lukas Marti, Oberarzt mbF, Cantonal Hospital of St. Gallen |
| ClinicalTrials.gov Identifier: | NCT01069016 History of Changes |
| Other Study ID Numbers: | SNS/PNS |
| Study First Received: | February 11, 2010 |
| Last Updated: | May 3, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Cantonal Hospital of St. Gallen:
|
Fecal Incontinence Colorectal surgery Sacral nerve stimulation Pudendal nerve stimulation |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013