Vaginal FistulaFMCVVFNCT03414060
Feasibility of the Menstrual Cup for VVF
A study testing Menstrual Cup in people with Vaginal Fistula and Vesico Vaginal Fistula, run by University of Ghana Medical School at 1 site in Ghana.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Vaginal Fistula, Vesico Vaginal Fistula, Obstetric; Injury
- What is being tested?
- Menstrual Cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGhana
- Study dates
- 8 Aug 2016to 2 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient seeking surgical repair for VVF
- VVF confirmed by gynecologic examination
- Adequate vaginal capacity to accommodate the menstrual cup
- Fistula high in vagina (determined at gynecologic examination)
- Willingness to insert and remove the device by one's self
Who cannot join
- Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)
- Unable or unwilling to learn to insert and remove the menstrual cup
- Patient who declines consent or is incapable of consent
- Presence of rectovaginal fistula (RVF) or combined RVF and VVF
- Fistula low in the vagina precluding collection of urine by the menstrual cup
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaginal Fistula, Vesico Vaginal Fistula, Obstetric; Injury
- Being tested
- Menstrual Cup
- Keywords
- obstetric fistula, vesicovaginal fistula, menstrual cup, pad test, non-surgical management, feasibility, acceptability, innovation, coping, incontinence
- Medical subject headings
- Vaginal Fistula, Vesicovaginal Fistula, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual CupDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Menstrual Cup) | Experimental | 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. Receives: Device: Menstrual Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of urinary leakage (in ml)
Measured by 2-hr pad test
Measured: Over 2 hours
Secondary outcomes (5)
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.
Measured: Over 2 hours
Adverse events
Erythema, edema/induration, erosion, bleeding assessed by clinical exam
Measured: Over 2 hours
Rate of enrollment through study completion
Number of individuals who enroll out of the total number of individuals screened
Measured: 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
Measured: 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.
Measured: After 1 hour of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start8 Aug 2016
- Primary completion2 Dec 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- repeated measures
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ghana Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, NYU Langone Health, Korle-Bu Teaching Hospital, Accra, Ghana
- Responsible party
- Sponsor
- Investigators
- Gabriel YK Ganyaglo, MD, Principal investigator, Korle-Bu Teaching Hospital, Accra, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414060
- Sponsor's protocol ID
- CHS-Et/M.9-P3.2/2015-2016
- Acronym
- FMCVVF
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available as supplementary documents in publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Menstrual Cup for Non-Surgical Management of VVF Among Women Seeking Care at a Health Facility in Ghana
- ClinicalTrials.gov ID
- NCT03414060
- Acronym / sponsor ID
- FMCVVF / CHS-Et/M.9-P3.2/2015-2016
- Conditions
- Vaginal Fistula, Vesico Vaginal Fistula, Obstetric; Injury
- Keywords
- obstetric fistula, vesicovaginal fistula, menstrual cup, pad test, non-surgical management, feasibility, acceptability, innovation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Ghana Medical SchoolUniversity, hospital or other
- Collaborators
- New York University, NYU Langone Health, Korle-Bu Teaching Hospital, Accra, Ghana
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- repeated measures
| Arm | Type | Receives |
|---|---|---|
| Intervention (Menstrual Cup) | Experimental | Device: Menstrual CupThe 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient seeking surgical repair for VVF
- VVF confirmed by gynecologic examination
- Adequate vaginal capacity to accommodate the menstrual cup
- Fistula high in vagina (determined at gynecologic examination)
- Willingness to insert and remove the device by one's self
Key exclusion criteria (5 listed)
- Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)
- Unable or unwilling to learn to insert and remove the menstrual cup
- Patient who declines consent or is incapable of consent
- Presence of rectovaginal fistula (RVF) or combined RVF and VVF
- Fistula low in the vagina precluding collection of urine by the menstrual cup
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual Cup | Device | Intervention (Menstrual Cup) |
Primary outcome
Volume of urinary leakage (in ml)
Time frame: Over 2 hours
Measured by 2-hr pad test
5 secondary outcomes
Acceptability of the menstrual cup
Time frame: Over 2 hours
Adverse events
Time frame: Over 2 hours
Rate of enrollment through study completion
Time frame: through study completion, an average of 1 year
Rate of consent through study completion
Time frame: through study completion, an average of 1 year
Perceived assessment of leakage with use of the menstrual cup
Time frame: After 1 hour of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Available as supplementary documents in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel YK Ganyaglo, MD principal investigator
Korle-Bu Teaching Hospital, Accra, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual Cup in people with Vaginal Fistula and Vesico Vaginal Fistula, run by University of Ghana Medical School at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of urinary leakage (in ml) (time frame: Over 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.