Female Pelvic Med Reconstr Surg 2021 May 4. Epub 2021 May 4.
From the Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, PA Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego Health, San Diego, CA Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's & Infants Hospital, Providence, RI Department of Obstetrics and Gynecology, Duke University Medical Center, Durham Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC Albany Medical College, Albany, NY University of New Mexico, Albuquerque, NM Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Objectives: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage.
Methods: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. Read More