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

Conditions:Gastrointestinal, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Age Range:18 - Any
Start Date:January 2011
End Date:October 2013

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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)

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

7. Has a sphincter injury that needs sphincteroplasty

8. Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel

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
We found this trial at
185 Cambridge Street
Boston, Massachusetts 02114
Boston, MA
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