Abstract
ObjectiveTo assess the feasibility of the menstrual cup for short-term management of urinary leakage among women with vesicovaginal fistula (VVF)MethodsA repeated measures design compared volume of leakage with and without the cup via a 2-hr pad test among women with VVF seeking surgical repair at a health facility in Ghana. Subsequently a gynecological exam was administered to assess safety outcomes, followed by a questionnaire to assess acceptability and perceived efficacy. A paired t-test was used to analyze reduction of leakage in ml, and percent reduction was reported. Study limitations include observer bias while evaluating adverse outcomes and the possibility of social desirability bias during questionnaire administration that might overestimate the effect of the cup and women’s acceptability.ResultsOf the 32 patients screened, 11 were eligible (100% consent rate). At baseline, mean (±SD) leakage in ml was 63.2 (±49.2) (95% CI: 30.2–96.3) over two hours, while the mean leakage over two hours of use of the cup was 16.8 (±16.5) (95% CI: 5.7–27.9). The mean difference of 46.4 (±52.1) ml with use of the cup (95% CI: 11.4–81.4) was statistically significant (p = 0.02). With the cup, women experienced an average 61.0% (±37.4) (95% CI: 35.9–86.2) leakage reduction, a difference 10/11 users (91.0%) perceived in reduced leakage. One participant, reporting four previous surgical attempts, experienced a 78.7% leakage reduction. Acceptability was high—women could easily insert (8/11), remove (8/11), and comfortably wear (11/11) the cup and most (10/11) would recommend it. No adverse effects attributable to the intervention were observed on exam, although some women perceived difficulties with insertion and removal. Data collection tools were appropriate with slight modification advised.ConclusionA larger trial is warranted for a more robust evaluation of the menstrual cup for management of urinary leakage due to VVF among women who have not yet accessed surgery or for whom surgery was not successful.
Highlights
Vesicovaginal fistula (VVF) is a debilitating maternal morbidity that largely results from complications of prolonged, obstructed labor when the trapped fetal head applies direct pressure to pelvic tissues
Women living with VVF experience urinary incontinence which causes discomfort, malodor, and skin irritation
This was a single arm, non-randomized, repeated measures feasibility study of the menstrual cup for short-term non-surgical management of urinary leakage associated with VVF
Summary
Vesicovaginal fistula (VVF) is a debilitating maternal morbidity that largely results from complications of prolonged, obstructed labor when the trapped fetal head applies direct pressure to pelvic tissues. This can cause widespread ischemia, tissue necrosis, and formation of a hole or fistula between the bladder and the vagina ( recto-vaginal fistula, or RVF, can form between the vagina and rectum, this more severe, less common form is not the focus of this work) [1]. Women living with VVF experience urinary incontinence which causes discomfort, malodor, and skin irritation. The West African nation of Ghana is estimated to have over 1,300 new cases annually [4]
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