Status:
COMPLETED
Neuromodulation for Accidental Bowel Leakage
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborating Sponsors:
University of Alabama at Birmingham
University of California, San Diego
Conditions:
Fecal Incontinence
Bowel Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treat...
Detailed Description
The overarching goal of this randomized clinical trial is to determine if PTNS is more effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1 year after initiating...
Eligibility Criteria
Inclusion
- Women ≥ 18 years of age
- FI symptoms ≥ 3 months
- Baseline St. Mark's score of ≥ 12
- Attended ≥ 2 supervised PMT for ABL
- Intolerance, unwillingness, or inadequate response to constipating medications
- Current negative colon cancer screening based on the USPSTF's recommendation for colorectal cancer screening (2016)
Exclusion
- Previous PTNS treatment
- History of uncontrolled diarrhea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale)
- History of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale)
- History of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis, but does not include irritable bowel disease)
- Unrepaired rectovaginal fistula/chronic 4th degree laceration
- Full thickness rectal prolapse
- History of congenital anorectal malformation
- History of bowel resection surgery for any indication
- Minor anal procedures within 6 months for treatment of ABL (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids
- Prior pelvic or abdominal radiation
- Diagnosis of cancer of the descending colon or anus
- Diagnosis of cancer in the region where the PTNS or sham needles or surface electrodes would be placed
- Pacemaker, implantable defibrillator
- Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs
- Clinically significant neurological disorders known to affect anal continence
- Coagulopathy
- Severe peripheral edema preventing accurate placement of PTNS needles
- Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS or sham needles or surface electrodes would be placed
- Metal implant in foot/toes near TENS electrode location
- Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS or sham needles or surface electrodes would be placed
- Childbirth within the last 3 months
- Pregnant or planning to become pregnant during the study duration 1 year; a urine pregnancy test will be performed and must be negative by the first intervention visit if the participant is of childbearing potential
- Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential
- Participation in another intervention trial impacting bowel function
- Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions
- Unable or unwilling to complete the bowel diary in Run-In Phase (valid diary defined as data from ≥ 10 of 14 days with minimum of 3 consecutive days per week)
- Unwilling to download bowel diary app onto smartphone if the participant owns a smartphone
- Visual impairment prohibiting reading the paper diary, the smart phone screen
- Unable to speak, read, or write in English or Spanish at a basic level
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2020
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03278613
Start Date
February 9 2018
End Date
March 9 2020
Last Update
June 3 2025
Active Locations (9)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
2
Kaiser Permanente -- Downey
Downey, California, United States, 90242
3
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, United States, 92037-0974
4
Kaiser Permanente -- San Diego
San Diego, California, United States, 92110