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: April 7, 2014
Last verified: April 2014

February 11, 2010
April 7, 2014
February 2010
January 2014   (final data collection date for primary outcome measure)
Power consumption of stimulator [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Power consumption of stimulator [ Time Frame: 7, 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01069016 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 (SF36v2, FIQL (Rockwood 2000)) [ Time Frame: 14 days, 3, 6 & 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence
Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Fecal Incontinence
  • 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: 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.
    Interventions:
    • Procedure: Sacral nerve modulation
    • Procedure: Pudendal nerve stimulation
  • 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.
    Interventions:
    • Procedure: Sacral nerve modulation
    • Procedure: Pudendal nerve stimulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • fecal incontinence nonresponsive to conservative treatment

Exclusion Criteria:

  • sacral or perineal infection
  • sphincter defect larger than 60° (sonography)
  • pregnancy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01069016
SNS/PNS
No
Lukas Marti, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Principal Investigator: Lukas Marti, MD Dep. of Surgery, Cantonal Hospital St. Gallen
Cantonal Hospital of St. Gallen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP