Clinical trial NCT03278613: Neuromodulation for Accidental Bowel Leakage
Official title: Neuromodulation for Accidental Bowel Leakage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Bowel Incontinence
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: University of Alabama at Birmingham
name: University of California, San Diego
name: Duke University
name: Women and Infants Hospital of Rhode Island
name: RTI International
name: University of Pennsylvania
name: University of Pittsburgh
name: Kaiser Permanente
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Texas Southwestern Medical Center
First posted: 2017-09-11
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women.

The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.

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 treatment. This is a two-part trial with a Run-In Phase prior to randomization. The trial has the following primary aim:

To determine whether the change from baseline in St. Mark's (Vaizey) score in women with symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation.

Additional secondary aims include:

1. To compare changes from baseline in self-reported functional outcomes after 12 weekly stimulation sessions in both PTNS and sham groups in Part 1.
2. To determine whether symptom relief amongst study "responders" can be sustained for one year with maintenance treatments in Part II.
3. To determine the impact of completing a bowel diary and receiving education on FI on symptom severity.
4. To determine the ability of the PFDN ABL phone app bowel diary to detect changes from baseline in fecal incontinence episodes recorded to after 12 weeks of stimulation sessions.
5. To determine the association between St. Mark's score and both fat and fiber intake alone and in combination.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline St. Mark's (Vaizey) Score
timeFrame: 4, 8, and 12 Weeks
Secondary outcomes:
measure: Responder to Treatment
timeFrame: 4, 8, and 12 Weeks
measure: Change From Baseline Number of Fecal Incontinence Events Per Week
timeFrame: 8 and 12 Weeks
measure: Change From Baseline Number of Urge Fecal Incontinence Events Per Week
timeFrame: 8 and 12 Weeks
measure: Change From Baseline Number of Bowel Movements Per Week
timeFrame: 8 and 12 Weeks
measure: Change From Baseline Number of Urge Bowel Movements Per Week
timeFrame: 8 and 12 Weeks
measure: Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week
timeFrame: 8 and 12 Weeks
measure: 50% Improvement in Fecal Incontinence Episodes Per Week
timeFrame: 8 and 12 Weeks
measure: 75% Improvement in Fecal Incontinence Episodes Per Week
timeFrame: 8 and 12 Weeks
measure: Patient Global Impression-Improvement
timeFrame: 4, 8, and 12 Weeks
Other outcomes:
measure: Change From Baseline ABLe Liquid Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Solid Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Mucus Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Gas Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Predictability/Awareness Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Control Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Ancillary Bowel Symptoms Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline ABLe Overall Score
timeFrame: 8 and 12 Weeks
measure: Patient Global Symptom Control
timeFrame: Baseline and 4, 8, and 12 Weeks
measure: Change From Baseline FIQL Lifestyle Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline FIQL Coping Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline FIQL Depression Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline FIQL Embarrassment Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline FISI Patient Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline FISI Doctor Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Incontinence Impact Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Role Limitations Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Physical Limitations Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Social Limitations Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Personal Relationship Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Emotional Function Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Sleep/Energy Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline MMHQ Severity Measures Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline CRAIQ Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline POPIQ Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline UIQ Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline PFIQ Score
timeFrame: 8 and 12 Weeks
measure: Change From Baseline PAC-SYM Abdominal Score
timeFrame: 12 Weeks
measure: Change From Baseline PAC-SYM Rectal Score
timeFrame: 12 Weeks
measure: Change From Baseline PAC-SYM Stool Score
timeFrame: 12 Weeks
measure: Change From Baseline PAC-SYM Total Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR NSA-PR Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR NSA-CS Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR NSA-GQA Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR NSA-CI Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-AO Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-PR Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-CS Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-GQR Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-CI Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-D Score
timeFrame: 12 Weeks
measure: Change From Baseline PISQ-IR SA-AVG Score
timeFrame: 12 Weeks
measure: Change From Baseline FIAI Hygiene Index Score
timeFrame: 12 Weeks
measure: Change From Baseline FIAI Avoidance Index Score
timeFrame: 12 Weeks
measure: Change From Baseline SF-12 Aggregate Physical Score
timeFrame: 12 Weeks
measure: Change From Baseline SF-12 Aggregate Mental Score
timeFrame: 12 Weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Downey
country: United States
facility: Kaiser Permanente -- Downey
state: California
city: La Jolla
country: United States
facility: University of California at San Diego, UCSD Women's Pelvic Medicine Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente -- San Diego
state: California
city: Durham
country: United States
facility: Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital, Department of Obstetrics and Gynecology
state: Pennsylvania
city: Providence
country: United States
facility: Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Magee-Women's Hospital, Department of Obstetrics and Gynecology
name: Halina M Zyczynski, MD
role: STUDY_CHAIR
References:
citation: Zyczynski HM, Richter HE, Sung VW, Lukacz ES, Arya LA, Rahn DD, Visco AG, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial. Am J Gastroenterol. 2022 Apr 1;117(4):654-667. doi: 10.14309/ajg.0000000000001605.
citation: Zyczynski HM, Arya LA, Lukacz ES, Richter HE, Rahn DD, Sung VW, Visco AG, Shaffer A, Jelovsek JE, Rogers R, Mazloomdoost D, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN). Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):726-734. doi: 10.1097/SPV.0000000000001050.