A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence

Female Pelvic Medicine & Reconstructive Surgery
Holly E RichterJennifer Wu

Abstract

The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system. This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50% or greater reduction in baseline FI episodes, also assessed at 6 and 12 months. Secondary outcomes included symptom impact measured with Fecal Incontinence Quality of Life scale, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events were collected. Primary analysis was intention to treat (ITT). Seventy-three subjects with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6% (53/73, P < 0.0001); per-protocol, 84.1% (53/63, P < 0.0001). Significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark's questionnaire meeting minimally important differences was noted. ...Continue Reading

References

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Sep 12, 2012·The American Journal of Gastroenterology·Brijen J ShahSuzanne Rose
Nov 20, 2012·American Journal of Obstetrics and Gynecology·Sallis O YipElisabeth A Erekson
Feb 28, 2013·Female Pelvic Medicine & Reconstructive Surgery·Heidi W BrownEmily S Lukacz
Mar 3, 2015·Obstetrics and Gynecology·Holly E RichterMadhulika G Varma
Mar 18, 2015·Women's Health·Isuzu Meyer, Holly E Richter
Aug 8, 2015·Diseases of the Colon and Rectum·Emily S LukaczSteven D Wexner
Jan 7, 2016·Diseases of the Colon and Rectum·Madhulika G VarmaHolly E Richter
Apr 7, 2016·Diseases of the Colon and Rectum·Mary L ForteRobert L Kane
Aug 27, 2016·Female Pelvic Medicine & Reconstructive Surgery·Catherine A MatthewsHolly E Richter

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Citations

Jul 18, 2020·United European Gastroenterology Journal·Ferdinando D'AmicoLaurent Peyrin-Biroulet
Sep 15, 2020·Obstetrics and Gynecology·Heidi W BrownRebecca G Rogers
Sep 10, 2019·F1000Research·Giovanna Da Silva, Anne Sirany
Aug 3, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Amanda P Stanton, Anita H Chen
Sep 15, 2020·Current Opinion in Obstetrics & Gynecology·Youngwu KimEmily Von Bargen
Feb 5, 2021·Clinics in Colon and Rectal Surgery·Srinivas Joga IvaturyIan M Paquette
Aug 22, 2021·Obstetrics and Gynecology Clinics of North America·Isuzu Meyer, Holly E Richter

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