NCT01274585

Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Posterior tibial nerve stimulation (PTNS)	Stimulation using PTNS device for 30 minutes weekly for 12 weeks
DEVICE	Posterior tibial nerve stimulation	Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-01-11
• Last updated: 2018-01-05
• Results posted: 2014-02-13

Locations

1 site across 1 country: United States