Feasibility and acceptability of the menstrual cup for non-surgical management of vesicovaginal fistula among women at a health facility in Ghana

Abstract

Objective: To assess the feasibility of the menstrual cup for short-term management of urinary leakage among women with vesicovaginal fistula (VVF).

Methods: A 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.

Results: Of 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.

Conclusion: A 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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Study flow chart.

The mean (±SD) volume of urine leaked over two hours at baseline was 63.2 (±49.2) ml (95% CI: 30.2–96.3). Most participants self-reported usually changing their cloth more than three times daily, with half (5/11) reporting five or more times (Table 3). The Shapiro-Wilks test suggests that the assumption of normal distribution is not rejected for observed baseline leakage (W = 0.94; critical threshold = 0.85).