Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 21, 2017
July 1, 2017
4.4 years
February 11, 2010
July 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Power consumption of stimulator
14 days
Secondary Outcomes (3)
Wexner Score (Jorge 1993)
7, 14 days, 3, 6 & 12 months
Incidence of surgical complications (adverse events) graded according to Dindo (2004)
30 days
Quality of Life (FIQL (Rockwood 2000))
14 days, 3, 6 & 12 months
Study Arms (2)
Sacral nerve modulation first
EXPERIMENTALSacral nerve modulation is applied before the pudendal nerve stimulation. There is no "wash-out" period (pause) between the two treatments.
Pudendal nerve stimulation first
EXPERIMENTALPudendal nerve stimulation is applied before the sacral nerve modulation. There is no "wash-out" period (pause) between the two treatments.
Interventions
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.
Eligibility Criteria
You may qualify if:
- fecal incontinence nonresponsive to conservative treatment
You may not qualify if:
- sacral or perineal infection
- sphincter defect larger than 60° (sonography)
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgey, Cantonal Hospital St. Gallen
Sankt Gallen, 9007, Switzerland
Related Publications (5)
Spinelli M, Sievert KD. Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Eur Urol. 2008 Dec;54(6):1287-96. doi: 10.1016/j.eururo.2008.01.076. Epub 2008 Feb 8.
PMID: 18336992BACKGROUNDSpinelli M, Malaguti S, Giardiello G, Lazzeri M, Tarantola J, Van Den Hombergh U. A new minimally invasive procedure for pudendal nerve stimulation to treat neurogenic bladder: description of the method and preliminary data. Neurourol Urodyn. 2005;24(4):305-9. doi: 10.1002/nau.20118.
PMID: 15977260BACKGROUNDJorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
PMID: 8416784BACKGROUNDRockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
PMID: 10813117BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lukas Marti, MD
Dep. of Surgery, Cantonal Hospital St. Gallen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Leitender Arzt
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2014
Study Completion
February 1, 2015
Last Updated
July 21, 2017
Record last verified: 2017-07