Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Primary Purpose
Fecal Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterior tibial nerve stimulation (PTNS)
Posterior tibial nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
No active treatment
stimulation/treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01274585
First Posted
January 7, 2011
Last Updated
December 5, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01274585
Brief Title
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Official Title
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to low recruitment rates
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No active treatment
Arm Type
Sham Comparator
Arm Title
stimulation/treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Posterior tibial nerve stimulation (PTNS)
Other Intervention Name(s)
Urgent PC
Intervention Description
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Intervention Type
Device
Intervention Name(s)
Posterior tibial nerve stimulation
Intervention Description
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
Primary Outcome Measure Information:
Title
Frequency of Fecal Incontinence
Description
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.
Time Frame
Diary kept for 14 days following treatment
Secondary Outcome Measure Information:
Title
Change in Fecal Incontinence Severity Index (FISI) Score
Description
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.
Time Frame
12 weeks
Title
Change in Fecal Incontinence Quality of Life (FIQoL) Score
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liliana Bordeianou, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
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