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

Mass General Brigham

Status: Terminated

Conditions: Fecal Incontinence

Treatments: Device: Posterior tibial nerve stimulation; Device: Posterior tibial nerve stimulation (PTNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01274585

MGH2010-P-000239

Details and patient eligibility

About

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).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups

No active treatment

Sham Comparator group

Treatment:

Device: Posterior tibial nerve stimulation

stimulation/treatment

Experimental group

Treatment:

Device: Posterior tibial nerve stimulation (PTNS)