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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233-7333
Contact:
Kathy Carter, RN, BSN
205-934-7874
mailto:kcarter@uabmc.edu

More Details

NCT ID
NCT03278613
Status
Recruiting
Sponsor
NICHD Pelvic Floor Disorders Network

Study Contact

Halina M Zyczynski, MD
(412) 641-1440
hzyczynski@mail.magee.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.