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Neuromodulation for Accidental Bowel Leakage (NOTABLe)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified September 2017 by NICHD Pelvic Floor Disorders Network
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
Duke University
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT03278613
First received: September 6, 2017
Last updated: September 7, 2017
Last verified: September 2017
  Purpose

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.


Condition Intervention
Fecal Incontinence Device: ES-130

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Participants will remain masked to subject treatment assignment throughout the trial. To maintain masking of participants, the duration of treatment sessions for both the PTNS and sham groups will be 30 minutes and will be conducted with subjects in a supine position with the knees comfortably abducted and flexed. The leg and foot involved in treatment will be obscured from the subject's view with a portable anesthesia drape frame to which an exam sheet will be secured.
Primary Purpose: Treatment
Official Title: Neuromodulation for Accidental Bowel Leakage

Resource links provided by NLM:


Further study details as provided by NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • St. Mark's (Vaizey) Score (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline St. Mark's (Vaizey) Score after 12 weeks of stimulation and after 1 year of treatment


Secondary Outcome Measures:
  • Episodes of fecal incontinence (FI) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline 14-day bowel diary FI episodes after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Accidental Bowel Leakage Symptom questionnaire (ABLe) score (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline ABLe score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Fecal Incontinence Quality of Life (FIQL) questionnaire score (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline FIQL score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Modified Manchester Questionnaire with Female Sexual Function Index (FSFI) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline Modified Manchester FSFI score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline PFDI-20 score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Patient Assessment Of Constipation Symptoms (PAC-SYM) Questionnaire (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline PAC-SYM score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline PISQ-IR score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Fecal Incontinence Adaptation Index Questionnaire (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline FI Adaptation Index score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • Self-reported use of constipating medications over time (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change in constipating medication use reported on St. Mark's (Vaizey) Score questionnaire (Question 3b) over time

  • Patient Global Impression of Improvement (PGI-I) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change in PGI-I scores over time

  • Patient Global Symptom Control (PGSC) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change in PGSC scores over time

  • 12-Item Short Form Health Survey (SF-12) (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Change from baseline SF-12 score after 12 weeks of stimulation sessions in Part 1 and after 1 year in Part 2

  • PTNS Treatment Adherence and Feasibility of Treatment Schedule in Part 1 [ Time Frame: 12 weeks ]
    Percent who attend 10 of 12 scheduled PTNS treatments in Part I

  • PTNS Treatment Adherence and Feasibility of Treatment Schedule in Part 2 [ Time Frame: 1 year ]
    Percent who attend 9 of 11 sessions in Part 2 (Fixed schedule)

  • Validity of the Sham (Part 1) [ Time Frame: 12 weeks ]
    Percent correctly identifying their treatment assignment via masking assessment form

  • Rate of UTIs treated with antibiotics (PTNS vs. Sham) [ Time Frame: 12 weeks, 1 year ]
    Difference in rate between the PTNS and Sham Groups reported via the Medical History Follow-Up Form in Part 1 and Part 2

  • Cost of PTNS Maintenance Schedules [ Time Frame: 1 year ]
    Mean number of PTNS treatments/year and mean treatment interval for those receiving PTNS in Part 2 via Treatment Form

  • Ability of PFDN accidental bowel leakage (ABL) phone app diary to detect change. [ Time Frame: 12 weeks ]
    Change from baseline fecal incontinence episodes recorded on phone app diary compared to change from baseline St. Mark's score after 12 weeks of stimulation


Estimated Enrollment: 359
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Percutaneous Tibial Nerve Stimulation (PTNS)
PTNS treatment entails insertion of a 34 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.
Device: ES-130
The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Sham Comparator: Validated Sham
Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation using the ES-130 device pulse generator.
Device: ES-130
The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03278613

Contacts
Contact: Halina M Zyczynski, MD (412) 641-1440 hzyczynski@mail.magee.edu
Contact: Donna Mazloomdoost, MD (301) 594-1336 donna.mazloomdoost@nih.gov

Locations
United States, Alabama
The University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233-7333
Contact: Holly E Richter, PhD, MD    205-934-7874    hrichter@uabmc.edu   
Principal Investigator: Holly E Richter, MD, PhD         
United States, California
Kaiser Permanente -- Downey Not yet recruiting
Downey, California, United States, 90242
Contact: John N Nguyen, MD    562-657-2642    John.N.Nguyen@kp.org   
Principal Investigator: John N Nguyen, MD         
University of California at San Diego, UCSD Women's Pelvic Medicine Center Not yet recruiting
La Jolla, California, United States, 92037-0974
Contact: Emily Lukacz, MD    858-657-8435    elukacz@ucsd.edu   
Principal Investigator: Emily Lukacz, MD         
Kaiser Permanente -- San Diego Not yet recruiting
San Diego, California, United States, 92110
Contact: Shawn A Menefee, MD    619-221-6200    Shawn.A.Menefee@kp.org   
Principal Investigator: Shawn A Menefee, MD         
United States, North Carolina
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery Not yet recruiting
Durham, North Carolina, United States, 27707
Contact: Anthony G Visco, MD    919-401-1018    anthony.visco@duke.edu   
Principal Investigator: Anthony G Visco, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lily Arya, MD, MS    215-615-6569    LArya@obgyn.upenn.edu   
Principal Investigator: Lily Arya, MD, MS         
Magee-Women's Hospital, Department of Obstetrics and Gynecology Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Halina M Zyczynski, MD    412-641-1440    hzyczynski@mail.magee.edu   
Principal Investigator: Halina M Zyczynski, MD         
United States, Rhode Island
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery Not yet recruiting
Providence, Rhode Island, United States, 02903
Contact: Vivian Sung, MD    401-453-7560    VSung@WIHRI.org   
Principal Investigator: Vivian Sung, MD         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: David Rahn, MD    214-645-3848      
Principal Investigator: David Rahn, MD         
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
University of Alabama at Birmingham
University of California, San Diego
Duke University
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Investigators
Study Chair: Halina M Zyczynski, MD Magee-Women's Hospital, Department of Obstetrics and Gynecology
  More Information

Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT03278613     History of Changes
Other Study ID Numbers: 12865-29
2U24HD069031-06 ( U.S. NIH Grant/Contract )
2UG1HD069013-06 ( U.S. NIH Grant/Contract )
5UG1HD041267-18 ( U.S. NIH Grant/Contract )
5UG1HD069010-07 ( U.S. NIH Grant/Contract )
5UG1HD069006-07 ( U.S. NIH Grant/Contract )
5UG1HD041261-17 ( U.S. NIH Grant/Contract )
5UG1HD054214-12 ( U.S. NIH Grant/Contract )
5UG1HD054241-12 ( U.S. NIH Grant/Contract )
Study First Received: September 6, 2017
Last Updated: September 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 19, 2017