Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Stopped early · Not applicable · Has a placebo group
Conditions studied: Fecal Incontinence
In brief
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).
Key facts
- Study ID
- NCT01274585
- Run by
- Massachusetts General Hospital
- People needed
- 5
- Starts
- 2011-01-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2018-01-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 years or older
- Able to provide informed consent
- Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
- Available to present for weekly treatments
- Available for follow-up at 3, 6, and 12 months
You may not qualify if…
- Severe cardiopulmonary disease
- Lesion of the Tibial Nerve
- Use of a cardiac pacemaker or implantable defibrillator
- History of inflammatory bowel disease
- Active anal fissure, fistula, or abscess
- Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy
- Has a sphincter injury that needs sphincteroplasty
- Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter
- Severe distal venous insufficiency
- Uncontrolled diabetes with peripheral nerve involvement
- Immunosuppression
- Pregnant or planning on becoming pregnant during treatment
- Patients prone to bleeding
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.