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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lukas Marti, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01069016
First received: February 11, 2010
Last updated: August 4, 2014
Last verified: August 2014
  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
Primary Completion Date: July 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:
  • 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 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:
  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069016

Locations
Switzerland
Department of Surgey, Cantonal Hospital St. Gallen
St.Gallen, Switzerland, 9007
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: August 4, 2014
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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014