A Phase 3 interventional study of Urgent PC neuromodulation system and Urgent PC neuromodulation system in Fecal Incontinence, sponsored by Maastricht University Medical Center. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-26.
Sponsored by Maastricht University Medical Center · Phase 3, Interventional, and Treatment
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-FI Score)
Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)
Subject's and Physician's Global Impression
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 59 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment group
Device: Urgent PC neuromodulation system
Sham group
Device: Urgent PC neuromodulation system
Urgent PC neuromodulation system
Urgent PC neuromodulation system (sham)
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
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
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center