Halina M Zyczynski1, Lily A Arya2, Emily S Lukacz3, Holly E Richter4, David D Rahn5, Vivian W Sung6, Anthony G Visco7, Amanda Shaffer8, J Eric Jelovsek7, Rebecca Rogers, Donna Mazloomdoost9, Marie G Gantz8. 1. From the Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh. 2. Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, PA. 3. Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego Health, San Diego, CA. 4. Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL. 5. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX. 6. Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's & Infants Hospital, Providence, RI. 7. Department of Obstetrics and Gynecology, Duke University Medical Center, Durham. 8. Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC. 9. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Abstract
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. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.
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. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.
Authors: Paul T J Janssen; Sara Z Kuiper; Laurents P S Stassen; Nicole D Bouvy; Stephanie O Breukink; Jarno Melenhorst Journal: Surgery Date: 2017-01-31 Impact factor: 3.982
Authors: J Eric Jelovsek; Alayne D Markland; William E Whitehead; Matthew D Barber; Diane K Newman; Rebecca G Rogers; Keisha Dyer; Anthony G Visco; Gary Sutkin; Halina M Zyczynski; Benjamin Carper; Susan F Meikle; Vivian W Sung; Marie G Gantz Journal: Lancet Gastroenterol Hepatol Date: 2019-07-15
Authors: Emma J Horrocks; Sami A Chadi; Natasha J Stevens; Steven D Wexner; Charles H Knowles Journal: Clin Gastroenterol Hepatol Date: 2017-06-21 Impact factor: 11.382
Authors: D A Drossman; Z Li; E Andruzzi; R D Temple; N J Talley; W G Thompson; W E Whitehead; J Janssens; P Funch-Jensen; E Corazziari Journal: Dig Dis Sci Date: 1993-09 Impact factor: 3.199