Feasibility of the Menstrual Cup for VVF (FMCVVF)

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Fistula; Vesico Vaginal Fistula; Obstetric; Injury
• Intervention / Treatment: Device: Menstrual Cup

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Central Region
    • Mankessim, Central Region, Ghana
      • Mercy Women's Catholic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Menstrual Cup); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of urinary leakage (in ml)	Measured by 2-hr pad test	Over 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse events	Erythema, edema/induration, erosion, bleeding assessed by clinical exam	Over 2 hours
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
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
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

Collaborators and Investigators

• Sponsor: University of Ghana Medical School
• Collaborators: New York University; NYU Langone Health; Korle-Bu Teaching Hospital, Accra, Ghana
• Investigators: Principal Investigator: Gabriel YK Ganyaglo, MD, Korle-Bu Teaching Hospital, Accra, Ghana

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2016
• Primary Completion (Actual): December 2, 2016
• Study Completion (Actual): December 2, 2016

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: coping; feasibility; incontinence; acceptability; vesicovaginal fistula; pad test; obstetric fistula; menstrual cup; non-surgical management; innovation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Urinary Bladder Diseases; Urogenital Abnormalities; Vaginal Diseases; Fistula; Pathological Conditions, Signs and Symptoms; Urinary Bladder Fistula; Urinary Fistula; Wounds and Injuries; Vaginal Fistula; Vesicovaginal Fistula; Equipment and Supplies; Feminine Hygiene Products; Menstrual Hygiene Products
• Other Study ID Numbers: CHS-Et/M.9-P3.2/2015-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available as supplementary documents in publication
• IPD Sharing Time Frame: The data are available through the publication indefinitely.
• IPD Sharing Access Criteria: Publication is posted in an open access journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No