Clinical Trial: Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study
Brief Summary:
Background of the study:
Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI.
A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials.
Objective of the study:
The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment.
Study design:
This study is a multicenter, single-blinded, randomized, placebo-controlled trial.
Primary study parameters/outcome of the study:
The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment.
Secondary study parameters/outcome of the study (if applicable):
Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF
Detailed Summary:
Sponsor: Maastricht University Medical Center
Current Primary Outcome: The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: 9 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score) at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: one year ]
- Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life) at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: one year ]
- Subject's and Physician's Global Impression at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Maastricht University Medical Center
Dates:
Date Received: September 8, 2009
Date Started: October 2009
Date Completion:
Last Updated: August 25, 2015
Last Verified: September 2010
