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

Not Applicable

Terminated

Interventions: Device: Posterior tibial nerve stimulation (PTNS)
Device: Posterior tibial nerve stimulation

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).

Recruitment & Eligibility

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
Immunosuppression
Pregnant or planning on becoming pregnant during treatment
Patients prone to bleeding

Arm && Interventions

Group	Intervention	Description
stimulation/treatment	Posterior tibial nerve stimulation (PTNS)	-
No active treatment	Posterior tibial nerve stimulation	-

Primary Outcome Measures

Name	Time	Method
Frequency of Fecal Incontinence	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 Outcome Measures

Name	Time	Method
Change in Fecal Incontinence Severity Index (FISI) Score	12 weeks	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.
Change in Fecal Incontinence Quality of Life (FIQoL) Score	12 weeks	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.