Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
This study is currently recruiting participants.
Verified December 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Liliana Bordeianou, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01274585
First received: January 7, 2011
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Fecal Incontinence |
Device: Posterior tibial nerve stimulation (PTNS) Device: Posterior tibial nerve stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Frequency of fecal incontinence [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]Bowel diary collected to assess frequency of fecal incontinence after bowel movements.
Secondary Outcome Measures:
- Change in Fecal Incontinence Severity Index (FISI) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Fecal Incontinence Quality of Life (FIQoL) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: Urgent PC
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274585
Contacts
| Contact: Lieba R Savitt, NP | 617-643-0541 | lsavitt@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Lieba R Savitt, NP 617-643-5766 lsavitt@partners.org | |
| Principal Investigator: Liliana Bordeianou, MD | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Liliana Bordeianou, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Liliana Bordeianou, Colorectal Surgeon, PI, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01274585 History of Changes |
| Other Study ID Numbers: | MGH2010-P-000239 |
| Study First Received: | January 7, 2011 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013