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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01274585
• Other study ID #: MGH2010-P-000239
• Status: Terminated
• Phase: N/A
• First received: January 7, 2011
• Last updated: December 5, 2017
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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:

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Posterior tibial nerve stimulation (PTNS)
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
• Posterior tibial nerve stimulation
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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