Study Results
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View full resultsBasic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2018-02-09
2020-03-09
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Percutaneous Tibial Nerve Stimulation (PTNS)
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
University of California, San Diego
OTHER
Duke University
OTHER
Women and Infants Hospital of Rhode Island
OTHER
RTI International
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
Kaiser Permanente
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Texas Southwestern Medical Center
OTHER
NICHD Pelvic Floor Disorders Network
NETWORK
Responsible Party
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Principal Investigators
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Halina M Zyczynski, MD
Role: STUDY_CHAIR
Magee-Women's Hospital, Department of Obstetrics and Gynecology
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Kaiser Permanente -- Downey
Downey, California, United States
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, United States
Kaiser Permanente -- San Diego
San Diego, California, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee-Women's Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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12865-29
Identifier Type: -
Identifier Source: org_study_id
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