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

July 20, 2017 updated by: Lukas Marti, Cantonal Hospital of St. Gallen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St.Gallen, Switzerland, 9007
        • Department of Surgey, Cantonal Hospital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fecal incontinence nonresponsive to conservative treatment

Exclusion Criteria:

  • sacral or perineal infection
  • sphincter defect larger than 60° (sonography)
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • SNM
  • Sacral nerve stimulation
  • SNS
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 Names:
  • 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:
  • SNM
  • Sacral nerve stimulation
  • SNS
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 Names:
  • PNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Power consumption of stimulator
Time Frame: 14 days
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Lukas Marti, MD, Dep. of Surgery, Cantonal Hospital St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNS/PNS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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