Feasibility of the Menstrual Cup for VVF

Obstetric; Injury Clinical Trial

— FMCVVF  

Official title:

Feasibility of the Menstrual Cup for Non-Surgical Management of VVF Among Women Seeking Care at a Health Facility in Ghana

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414060
• Other study ID #: CHS-Et/M.9-P3.2/2015-2016
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2016
• Est. completion date: January 25, 2019

Study information

• Verified date: October 2018
• Source: University of Ghana Medical School
• Contact: Nessa Ryan, MPH, MSCI
• Email: ryann01[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: January 25, 2019
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Obstetric; Injury
• Vaginal Fistula
• Vesico Vaginal Fistula
• Vesicovaginal Fistula

Intervention

Device:
• Menstrual Cup

Locations

Country	Name	City	State
Ghana	Mercy Women's Catholic Hospital	Mankesim	Central Region

Sponsors (4)

Lead Sponsor	Collaborator
University of Ghana Medical School	Korle-Bu Teaching Hospital, Accra, Ghana, New York University College of Global Public Health, New York University School of Medicine

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of urinary leakage (in ml)	Measured by 2-hr pad test	Over 2 hours
Secondary	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.	Over 2 hours
Secondary	Adverse events	Erythema, edema/induration, erosion, bleeding assessed by clinical exam	Over 2 hours
Secondary	Rate of enrollment through study completion	Number of individuals who enroll out of the total number of individuals screened	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	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.	After 1 hour of use