Neuromodulation for Accidental Bowel Leakage

NCT03278613 | Completed Results DMC FDA Device

• 9 other identifiers: 12865-292U24HD069031-062UG1HD069013-065UG1HD041267-185UG1HD069010-075UG1HD069006-075UG1HD041261-175UG1HD054214-125UG1HD054241-12
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 9

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.

Conditions

Fecal Incontinence; Bowel Incontinence

Outcome Measures

Primary Outcomes (1)

• Change From Baseline St. Mark's (Vaizey) Score

  The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week \[4, 8, or 12\] Score minus the score at baseline.

  4, 8, and 12 Weeks

Secondary Outcomes (9)

• Responder to Treatment

  4, 8, and 12 Weeks

• Change From Baseline Number of Fecal Incontinence Events Per Week

  8 and 12 Weeks

• Change From Baseline Number of Urge Fecal Incontinence Events Per Week

  8 and 12 Weeks

• Change From Baseline Number of Bowel Movements Per Week

  8 and 12 Weeks

• Change From Baseline Number of Urge Bowel Movements Per Week

  8 and 12 Weeks

Other Outcomes (46)

• Change From Baseline ABLe Liquid Score

  8 and 12 Weeks

• Change From Baseline ABLe Solid Score

  8 and 12 Weeks

• Change From Baseline ABLe Mucus Score

  8 and 12 Weeks

Study Arms (2)

Percutaneous Tibial Nerve Stimulation (PTNS)

EXPERIMENTAL

PTNS treatment entails insertion of a 36 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

Validated Sham

SHAM COMPARATOR

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.

Device: ES-130

Interventions

ES-130 DEVICE

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.

Percutaneous Tibial Nerve Stimulation (PTNS); Validated Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• University of Alabama at Birmingham: collaborator
• University of California, San Diego: collaborator
• Duke University: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• RTI International: collaborator
• University of Pennsylvania: collaborator
• University of Pittsburgh: collaborator
• Kaiser Permanente: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35233-7333, United States

Location

Kaiser Permanente -- Downey

Downey, California, 90242, United States

Location

University of California at San Diego, UCSD Women's Pelvic Medicine Center

La Jolla, California, 92037-0974, United States

Location

Kaiser Permanente -- San Diego

San Diego, California, 92110, United States

Location

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, 27707, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee-Women's Hospital, Department of Obstetrics and Gynecology

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

Providence, Rhode Island, 02903, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

• 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.

  PMID: 35354778 DERIVED

• 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.

  PMID: 33950027 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-597-5110

Study Officials

• Halina M Zyczynski, MD

  Magee-Women's Hospital, Department of Obstetrics and Gynecology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 11, 2017
• Study Start: February 9, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: June 3, 2025
• Results First Posted: May 14, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)