Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Sacral nerve modulation; Pudendal nerve stimulation
Intervention type(s): Procedure; Procedure
Intervention description(s): For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.; For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
Other intervention name(s): SNM; Sacral nerve stimulation; SNS; PNS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fecal Incontinence; Colorectal surgery; Sacral nerve stimulation; Pudendal nerve stimulation