Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Frequency of Fecal Incontinence
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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).
Investigators
Liliana Bordeianou
Colorectal Surgeon, PI
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Frequency of Fecal Incontinence
Time Frame: Diary kept for 14 days following treatment
Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.
Secondary Outcomes
- Change in Fecal Incontinence Severity Index (FISI) Score(12 weeks)
- Change in Fecal Incontinence Quality of Life (FIQoL) Score(12 weeks)