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

Study 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).

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

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Device: Posterior tibial nerve stimulation (PTNS)
* Device: Posterior tibial nerve stimulation


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: No active treatment<br> | Device: Posterior tibial nerve stimulation<br>* Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks<br>|
| Experimental: stimulation/treatment<br> | Device: Posterior tibial nerve stimulation (PTNS)<br>* Stimulation using PTNS device for 30 minutes weekly for 12 weeks<br>* Other names: Urgent PC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Diary kept for 14 days following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks |