Clinical trial NCT03414060: Feasibility of the Menstrual Cup for VVF
Official title: Feasibility of the Menstrual Cup for Non-Surgical Management of VVF Among Women Seeking Care at a Health Facility in Ghana
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Fistula
Vesico Vaginal Fistula
Obstetric; Injury
Keywords: obstetric fistula
vesicovaginal fistula
menstrual cup
pad test
non-surgical management
feasibility
acceptability
innovation
coping
incontinence
Lead sponsor: University of Ghana Medical School
Sponsor class: OTHER
Collaborators: name: New York University College of Global Public Health
name: NYU Langone Health
name: Korle-Bu Teaching Hospital, Accra, Ghana
First posted: 2018-01-29
Enrollment: 35
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: repeated measures
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patient seeking surgical repair for VVF
2. VVF confirmed by gynecologic examination
3. Adequate vaginal capacity to accommodate the menstrual cup
4. Fistula high in vagina (determined at gynecologic examination)
5. Willingness to insert and remove the device by one's self

Exclusion Criteria:

1. Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)
2. Unable or unwilling to learn to insert and remove the menstrual cup
3. Patient who declines consent or is incapable of consent
4. Presence of rectovaginal fistula (RVF) or combined RVF and VVF
5. Fistula low in the vagina precluding collection of urine by the menstrual cup

Primary outcomes:
measure: Volume of urinary leakage (in ml)
timeFrame: Over 2 hours
Secondary outcomes:
measure: Acceptability of the menstrual cup
timeFrame: Over 2 hours
measure: Adverse events
timeFrame: Over 2 hours
measure: Rate of enrollment through study completion
timeFrame: through study completion, an average of 1 year
measure: Rate of consent through study completion
timeFrame: through study completion, an average of 1 year
measure: Perceived assessment of leakage with use of the menstrual cup
timeFrame: After 1 hour of use
Other outcomes:
Locations:
city: Mankesim
country: Ghana
facility: Mercy Women's Catholic Hospital
state: Central Region
Study officials:
affiliation: Korle-Bu Teaching Hospital, Accra, Ghana
name: Gabriel YK Ganyaglo, MPH, MSCI
role: PRINCIPAL_INVESTIGATOR
References: