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

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 Overview

• Status: Terminated
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Posterior tibial nerve stimulation; Device: Posterior tibial nerve stimulation (PTNS)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: No active treatment	Device: Posterior tibial nerve stimulation; Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
Experimental: stimulation/treatment	Device: Posterior tibial nerve stimulation (PTNS); Stimulation using PTNS device for 30 minutes weekly for 12 weeks; 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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Liliana Bordeianou, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 10, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: MGH2010-P-000239