Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 7:33 AM
Study NCT ID:
NCT03414060
Status:
UNKNOWN
Last Update Posted:
2018-10-19
First Post:
2018-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of the Menstrual Cup for VVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014624', 'term': 'Vaginal Fistula'}, {'id': 'D014719', 'term': 'Vesicovaginal Fistula'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001747', 'term': 'Urinary Bladder Fistula'}, {'id': 'D014548', 'term': 'Urinary Fistula'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052576', 'term': 'Menstrual Hygiene Products'}], 'ancestors': [{'id': 'D053566', 'term': 'Feminine Hygiene Products'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'repeated measures'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of urinary leakage (in ml)', 'timeFrame': 'Over 2 hours', 'description': 'Measured by 2-hr pad test'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the menstrual cup', 'timeFrame': 'Over 2 hours', 'description': '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.'}, {'measure': 'Adverse events', 'timeFrame': 'Over 2 hours', 'description': 'Erythema, edema/induration, erosion, bleeding assessed by clinical exam'}, {'measure': 'Rate of enrollment through study completion', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of individuals who enroll out of the total number of individuals screened'}, {'measure': 'Rate of consent through study completion', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of individuals who complete the consent form out of the total number of screened individuals meeting all other inclusion and exclusion criteria'}, {'measure': 'Perceived assessment of leakage with use of the menstrual cup', 'timeFrame': 'After 1 hour of use', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstetric fistula', 'vesicovaginal fistula', 'menstrual cup', 'pad test', 'non-surgical management', 'feasibility', 'acceptability', 'innovation', 'coping', 'incontinence'], 'conditions': ['Vaginal Fistula', 'Vesico Vaginal Fistula', 'Obstetric; Injury']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nTraditional 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.\n\nWhile 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.\n\nA 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.\n\nBeginning 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient seeking surgical repair for VVF\n2. VVF confirmed by gynecologic examination\n3. Adequate vaginal capacity to accommodate the menstrual cup\n4. Fistula high in vagina (determined at gynecologic examination)\n5. Willingness to insert and remove the device by one's self\n\nExclusion Criteria:\n\n1. Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)\n2. Unable or unwilling to learn to insert and remove the menstrual cup\n3. Patient who declines consent or is incapable of consent\n4. Presence of rectovaginal fistula (RVF) or combined RVF and VVF\n5. Fistula low in the vagina precluding collection of urine by the menstrual cup"}, 'identificationModule': {'nctId': 'NCT03414060', 'acronym': 'FMCVVF', 'briefTitle': 'Feasibility of the Menstrual Cup for VVF', 'organization': {'class': 'OTHER', 'fullName': 'University of Ghana Medical School'}, 'officialTitle': 'Feasibility of the Menstrual Cup for Non-Surgical Management of VVF Among Women Seeking Care at a Health Facility in Ghana', 'orgStudyIdInfo': {'id': 'CHS-Et/M.9-P3.2/2015-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Menstrual Cup)', 'description': '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.', 'interventionNames': ['Device: Menstrual Cup']}], 'interventions': [{'name': 'Menstrual Cup', 'type': 'DEVICE', 'armGroupLabels': ['Intervention (Menstrual Cup)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mankessim', 'state': 'Central Region', 'status': 'RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'Nessa Ryan, MPH, MSCI', 'role': 'CONTACT', 'email': 'ryann01@nyu.edu', 'phone': '+1.704.806.2062'}, {'name': 'Gabriel Ganyaglo, MD', 'role': 'CONTACT', 'email': 'gganyaglo@hotmail.com', 'phone': '+1.704.806.2062'}], 'facility': "Mercy Women's Catholic Hospital", 'geoPoint': {'lat': 5.2717, 'lon': -1.0152}}], 'centralContacts': [{'name': 'Nessa Ryan, MPH, MSCI', 'role': 'CONTACT', 'email': 'ryann01@nyu.edu'}], 'overallOfficials': [{'name': 'Gabriel YK Ganyaglo, MPH, MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korle-Bu Teaching Hospital, Accra, Ghana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ghana Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York University College of Global Public Health', 'class': 'UNKNOWN'}, {'name': 'NYU Langone Health', 'class': 'OTHER'}, {'name': 'Korle-Bu Teaching Hospital, Accra, Ghana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}