Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Power consumption of stimulator
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •fecal incontinence nonresponsive to conservative treatment
Exclusion Criteria
- •sacral or perineal infection
- •sphincter defect larger than 60° (sonography)
- •pregnancy
Arms & Interventions
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.
Intervention: Sacral nerve modulation (Procedure)
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.
Intervention: Pudendal nerve stimulation (Procedure)
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.
Intervention: Sacral nerve modulation (Procedure)
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.
Intervention: Pudendal nerve stimulation (Procedure)
Outcomes
Primary Outcomes
Power consumption of stimulator
Time Frame: 14 days
Secondary Outcomes
- Wexner Score (Jorge 1993)(7, 14 days, 3, 6 & 12 months)
- Quality of Life (FIQL (Rockwood 2000))(14 days, 3, 6 & 12 months)
- Incidence of surgical complications (adverse events) graded according to Dindo (2004)(30 days)
Investigators
Lukas Marti
Leitender Arzt
Cantonal Hospital of St. Gallen