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URL: https://dx.doi.org/DOI:10.17504/protocols.io.sjfecjn

Authors: Gabriel Y. K. Ganyaglo, Nessa Ryan, Joonhee Park, A. T. Lassey

Summary: Background Vesicovaginal fistula is a debilitating condition resulting from prolonged obstructed labor. Globally, at least 2 million women are estimated to be living with fistula with about 50,000 to 100,000 new cases each year. More than 90% of the global burden of fistula is in sub-Saharan Africa and South East Asia. Traditional management of fistula requires surgical repair. However, many women either do not have access to surgery, or access to surgery is delayed. These categories of patients have few or no options to control the constant urinary leakage.  The vaginal menstrual cup is an insertable medical device approved for use in Europe and North America to collect menstrual flow. Because it collects fluid drainage from the vagina, it could also be used to control urine leakage in women with vesicovaginal fistula.  While surgical management of fistula would remain the gold standard in treatment, the menstrual cup could be an alternative for women who do not have access to surgery or are poor surgical candidates.General Aim To evaluate the menstrual cup for short-term non-surgical management of vesicovaginal fistula.Methodology This study will examine the reduction in urinary leakage for women with vesicovaginal fistula who use the cup over a 2 hour period. Fistula patients recruited after community durbars  will be invited to the hospital and offered enrollment. They will wear a sanitary pad for 2 hours and the pad will be weighed. The patients will then receive counseling on how to insert the cup in the vagina and will wear both the device and a sanitary pad for 2 hours. The second pad will also be weighed. The amount of urine leaked with and without the cup will be compared using a paired t-test. Addtionally, the women will answer a short questionnaire on the acceptability of the cup, and a physical exam will be carried out to assess safety with cup use. A purposeful sample of the patients will be recruited for in-depth interviews to share their experiences of coping with VVF and their acceptability of the menstrual cup device.Expected Outcome The knowledge gained from this study may offer alternative temporizing management options for fistulas, especially for women who fail or are awaiting surgery, women who cannot access surgery, or are poor surgical candidates.

Affiliations: Korle Bu Teaching Hospital, New York University, New York University, Korle Bu Teaching Hospital

Version: 1

Publication Date: 2018

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