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

Massachusetts General Hospital5 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Fecal Incontinence

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Severe cardiopulmonary disease 2. Lesion of the Tibial Nerve 3. Use of a cardiac pacemaker or implantable defibrillator 4. History of inflammatory bowel disease 5. Active anal fissure, fistula, or abscess 6. Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy 7. Has a sphincter injury that needs sphincteroplasty 8. Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter 9. Severe distal venous insufficiency 10. Uncontrolled diabetes with peripheral nerve involvement 11. Immunosuppression 12. Pregnant or planning on becoming pregnant during treatment 13. Patients prone to bleeding

Outcomes

Primary Outcomes

Frequency of Fecal Incontinence

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.

Time frame: Diary kept for 14 days following treatment

Secondary Outcomes

Change in Fecal Incontinence Severity Index (FISI) Score

Fecal Incontinence Severity Index (FISI) is a tool used to stratify severity of fecal incontinence in the subjects. The range of score is from 0 to 61 where the higher score correlates with more severe symptoms of incontinence.

Time frame: 12 weeks

Change in Fecal Incontinence Quality of Life (FIQoL) Score

The Fecal incontinence Quality of Life (FIQoL) score evaluates how fecal incontinence impacts the subjects quality of life. The scale ranges from 37 to 159 where the higher the score, the better the quality of life associated with symptoms.