An interventional study of Menstrual Cup in Vaginal Fistula, Vesico Vaginal Fistula and Obstetric; Injury, sponsored by University of Ghana Medical School. Completed at 1 site in Ghana. Open to female participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Ghana Medical School · Not applicable, Interventional, and Treatment
This study examines the feasibility and acceptability of the vaginal menstrual cup for short-term management of vesicovaginal fistula (VVF) among 11 women seeking treatment at a health facility in Ghana. The repeated measures design utilizes a 2-hr pad test to compare urinary leakage with and without the insertable cup, a questionnaire on acceptability and perceived effect is administered and a clinical exam is completed. Subsequently, semi-structured interviews will be carried out with up to 24 additional women seeking treatment at a health facility in Ghana. Interviews will cover women's experiences of living with fistula, including strategies for coping with urinary incontinence and resulting stigma, as well as user acceptability to the intervention.
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/vaginal tissues and causes widespread ischemia, tissue necrosis, and subsequent extensive fistula formation. Women living with VVF, the most common anatomical presentation of obstetric fistula, experience urinary incontinence which causes discomfort, malodor, and skin infection, as well as social and psychological consequences that increase their vulnerability to the negative effects of stigma and reduce their quality of life.
Traditional management requires surgical repair; however, many women either do not have access to surgery, or access is delayed due to various individual, social, or structural barriers. Non-surgical management, previously explored with non-invasive techniques for residual urinary incontinence, has been under-examined for fistula-related urinary incontinence. The menstrual cup may be a useful option for non-surgical management of obstetric fistula. Clinical and programmatic reports suggest a potential translation of the menstrual cup for collection or control of urine leakage in women with VVF; however, evidence has not been collected and examined systematically within a population in an endemic setting.
While surgical management of fistula remains the gold standard in treatment, research on non-surgical therapies is necessary.Therefore, this study aims to assess the feasibility (including efficacy, safety, and acceptability among users) of using the menstrual cup over a short period among women seeking care for VVF in a clinical setting and, unlike prior reports, includes standardized measures of leakage and prioritizes user perspectives.
A repeated measures design compared volume of leakage with the and without the cup to baseline leakage via a 2-hr pad test among women with VVF seeking surgical repair at a health facility in Ghana. A questionnaire was later administered followed by a physical exam. A paired t-test was used to analyze effect.
Beginning October 2018, semi-structured interviews with up to 24 women seeking treatment at a health facility in Ghana will be carried out on women's experience with fistula, including strategies for coping with urinary incontinence and resulting stigma, as well as their acceptability to the insertable device. This mixed methods approach is necessary to compare quantitative results and qualitative findings regarding what women are already doing to cope with incontinence and stigma, and their acceptability to this device to manage leaking and support coping.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 11 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Ghana Medical School is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The menstrual cup is a 100% silicone, flexible reservoir cup that, when inserted correctly in the vagina, is sanitary and efficacious in preventing leakage of menstrual blood and in eliminating odor.
Device: Menstrual Cup
Volume of urinary leakage (in ml)
Measured by 2-hr pad test
Time frame: Over 2 hours
Acceptability of the menstrual cup
Using a Likert scale with values ranging from 1-5, acceptability is reported based on ease of use, insertion, wearing, removal, and cleaning. A summarizing acceptability scale is not reported.
Time frame: Over 2 hours
Adverse events
Erythema, edema/induration, erosion, bleeding assessed by clinical exam
Time frame: Over 2 hours
Rate of enrollment through study completion
Number of individuals who enroll out of the total number of individuals screened
Time frame: through study completion, an average of 1 year
Rate of consent through study completion
Number of individuals who complete the consent form out of the total number of screened individuals meeting all other inclusion and exclusion criteria
Time frame: through study completion, an average of 1 year
Perceived assessment of leakage with use of the menstrual cup
Proportion of participants that perceive a reduction in leakage (either marked or slight) with use of the menstrual cup compared to their usual strategy for fistula management. This question uses likert-type responses to note whether the respondent perceives their urine leakage markedly improved, slightly improved, no change, slightly worse, or markedly worse.
Time frame: After 1 hour of use
Plan to share: Yes — Available as supplementary documents in publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data are available through the publication indefinitely.
Access criteria: Publication is posted in an open access journal.
Data sharing details ↗ · journals.plos.org
No publications or documents are linked to this record.
Ran from Aug 2016 to primary completion in Dec 2016, 3 months.
Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 3 months is below that.
Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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University of Ghana Medical School