Fecal Incontinence Clinical Trial
Official title:
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
The primary objective of this study is to determine whether Percutaneous Tibial Nerve
Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of
patients with urinary incontinence, can also be used to treat fecal incontinence.
Specifically, the primary endpoint of this study is to determine, in a randomized controlled
patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the
patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel
diary after treatment.
The investigators secondary endpoints will consist of measurements of the impact of PTNS on
the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity
Index (FISI) score ), as well as on the patient quality of life factors related to fecal
incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL)
scale).
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