A vaginal bowel-control system for the treatment of fecal incontinence

Obstetrics and Gynecology
Holly E RichterMadhulika G Varma

Abstract

To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscal...Continue Reading

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Citations

Feb 18, 2016·Obstetrics and Gynecology Clinics of North America·Isuzu Meyer, Holly E Richter
Jun 5, 2016·Gastroenterology Clinics of North America·Alison Freeman, Stacy Menees
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Jul 22, 2020·Journal of Clinical Gastroenterology·Satish S C Rao, Eula P Tetangco
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Aug 22, 2021·Obstetrics and Gynecology Clinics of North America·Isuzu Meyer, Holly E Richter
Oct 8, 2021·The American Journal of Gastroenterology·Arnold WaldMassarat Zutshi

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