Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209466217416 Date of Approval: 22/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness and Acceptability of two models of an Insertable Vaginal Cup for Non-surgical management of obstetric fistula in Ghana
Official scientific title Effectiveness and Acceptability of two models of an Insertable Vaginal Cup for Non-surgical management of obstetric fistula in Ghana: a hybrid type 1 randomized crossover trial
Brief summary describing the background and objectives of the trial The incidence of obstetric fistula far outstrips the global capacity for surgical repair. In the West African Sub-region, reports indicate women leaking urine from obstetric fistula wait an average of 5years before surgical repair. While awaiting surgery, many patients afflicted with obstetric fistula resort to homemade measures to cope with leakage of urine to avoid stigma. Preliminary investigations among 38 women seeking surgical repair in fistula treatment centres across Ghana reflect significant amount of energy and time expended by the women to cope with leakage and avoid stigma. The COPE study is a follow up to a feasibility trial of the menstrual cup among 11 fistula patients. Using a 2hour pad test from baseline, there was a 61% reduction in volume of urine leaked. The investigators of the COPE study propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COPE
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied VESICOVAGINAL FISTULA
Purpose of the trial Treatment: Devices
Anticipated trial start date 24/10/2022
Actual trial start date 15/04/2023
Anticipated date of last follow up 15/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cup 1 cup 24 hrs during clinic-based assessment; Up to 3-months follow-up during community-based assessment an insertable vaginal cup 100
Experimental Group Cup plus 1 'Cup plus' 24 hrs during clinic-based assessment; Up to 3-months follow-up during community-based assessment the cup attached via rubber tubing to a leg-secured urine collection bag for greater urine holding capacity 100
Control Group Leaking freely As many adult diapers and/or sanitary pads as needed by the participant 24 hrs during clinic-based assessment (half the sample will experience this control assignment twice, for a total duration of 24 hrs) adult diapers and/or sanitary pads to allow the participants to leak freely 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician) Willing to insert and remove cup/cup+ Clear understanding of the study procedures Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery If previous fistula repair, ≥3mo post-delivery If recent birth, age 18+ or emancipated minor Speak English or local language Any rectovaginal fistula Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 100 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/09/2022 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
PO Box KB 77 Korle Bu, Accra NA Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/05/2022 University of California San Francisco IRB
Ethics Committee Address
Street address City Postal code Country
UCSF Human Research Protection Program Box 1288 490 Illinois Street Floor 6 San Francisco 94143 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean change in volume of observed urine leakage Urine leakage will be measured in mL using pad weight baseline to 8 hours
Secondary Outcome Mean change in volume of perceived urine leakage Perceived urine leakage will be measured by the International Consultation on Incontinence Questionnaire SF (ICIQ-SF). This score ranges from 0-21 with higher scores indicating greater incontinence. baseline vs. 8 hours, 24 hours,1 month, 2 months and 3 months
Secondary Outcome Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score Quality of life will be measured using the WHOQOL-BREF. The score ranges from 0-100 with higher scores indicating higher quality of life. baseline vs. 24 hours, 1 month, 2 months and 3 months
Secondary Outcome Mean change in fistula-related stigma scale Stigma will be measured using the fistula-related stigma scale, and enacted and internalized subscales. This score ranges from 0-100 with higher scores indicating higher stigma. baseline vs. 1 month, 2 months and 3 months
Secondary Outcome Mean change in fistula management costs over time Fistula management costs will be calculated by combining the total material costs and lost wages in Ghanaian Cedi (local currency) over time. Time in minutes will inform calculations of lost wages using prevailing wage rates for the study population. The mean change in cost will be from baseline to 3 months. baseline vs. 1 month, 2 months, and 3 months
Secondary Outcome Mean change in sleep satisfaction using the WHO sleep index Sleep satisfaction using the adapted WHO sleep index. The score ranges from 1-5 where 1 is least satisfied and 5 is very satisfied. baseline vs. 1 month, 2 months, and 3 months
Secondary Outcome Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale Coping will be measured using the modified BRIEF Coping scale. The score ranges from 0-100 with higher scores indicating better coping. baseline vs. 1 month, 2 months, and 3 months
Secondary Outcome Mean change in perceived empowerment over time Empowerment change in the proportion of users across physical mobility, participation in income-generating activities, bodily autonomy, household decision making, reproductive autonomy, and social participation. Individual measures will be captured using a scale of 1-5, with 1 indicating lower empowerment and 5 higher. baseline vs. 1 month, 2 months, and 3 months
Secondary Outcome Changes in perceived safety over time change in the proportion of users who report any adverse events with use of the intervention model at 1, 2, and 3-month follow up baseline vs. 8 hours, 24 hours, 1 month, 2 months, and 3 months
Secondary Outcome Changes in user acceptability of the intervention over time Proportion of users who report the intervention as acceptable measured across domains including easy to insert, remove, clean, comfortable to wear, interference with activities, perceived efficacy, self-efficacy, intent to use, and reported using a mean acceptability scale (based on composite score of acceptability items) regarding the intervention model. Standardized range will be 0-100, with higher values meaning greater acceptability and lower values lower acceptability. 8 hours vs. 24 hours, 1 month, 2 months, and 3 months
Secondary Outcome Changes in post-fistula repair reintegration scale Reintegration will be measured using the post-fistula repair reintegration scale and subdomains comfort with relatives, relationship, general life satisfaction, family needs, and social engagement. The score ranges from 0-100 with higher scores indicating higher reintegration/functional status. baseline vs. 1 month, 2 months, and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mercy Womens Catholic Hospital Post Office Box MK 164 Mankesim Ghana
Tamale Fistula Center Tamale Fistula Center Tamale Ghana
Gynocare Womens and fistula hospital Off Uganda road, Kahoya, PO BOX 2326-30100 Eldoret 30100 Kenya
Infectious Disease Research Collaboration Kampala Head Office Plot 2C Nakasero Hill Road, P.O. Box 7475 Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Eunice Kennedy Shriver National Institute of Child Health and Human Development 9000 Rockville Pike Bethesda Maryland 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Korle Bu Teaching Hospital Guggisberg Avenue Accra Ghana Hospital
COLLABORATORS
Name Street address City Postal code Country
Restore Health Inc 166 Prospect Place Brooklyn 11238 United States of America
University of California San Francisco 550 16th Street Third Floor San Francisco CA 94158 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Nessa Ryan ryann01@nyu.edu +17048062062 166 Prospect Place
City Postal code Country Position/Affiliation
Brooklyn NY 11238 United States of America Study Director
Role Name Email Phone Street address
Principal Investigator Gabriel Ganyaglo gganyaglo@hotmail.com +233244807426 Korle Bu Teaching Hospital
City Postal code Country Position/Affiliation
Accra Ghana Ghana PI
Role Name Email Phone Street address
Scientific Enquiries Alison El Ayadi alison.elayadi@ucsf.edu +16178777424 Department of Obstetrics Gynecology and Reproductive Sciences University of California San Francisco 550 16th Street Third Floor
City Postal code Country Position/Affiliation
San Francisco 94158 United States of America US PI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Quantitative data sharing: Data will be deidentified and made available after all study publications have been completed without cost to researchers and analysts in Dryad, the open data repository of the University of California (https://datadryad.org). This data repository ensures long-term preservation and access with Digital Object Identifiers (DOIs), versioning, creative commons licenses, ORCID and Fundref identifiers, and search engine discoverability. Qualitative data sharing: We will make the full dataset and associated documentation available to users only under a data-sharing agreement that provides for: i) a commitment to using the data only for research purposes and not to identify any individual participant; ii) a commitment to securing the data using appropriate computer technology; and iii) a commitment to destroying or returning the data after analyses are completed. Abbreviated instructions for how to access qualitative data, including name of a contact person, will be provided in each publication. A summary version of the data, including relevant excerpts will also be deposited into Dryad, the open data repository of the University of California (https://datadryad.org). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Application Review. Resource requests will be collected monthly and distributed to the Investigators on the grant, who will then review and discuss recommendations during the regular Project Meetings. Investigators will be notified of the approval status within one week of the review. All new researchers interested in accessing data from the project will submit a resource request through the Principal Investigator (Dr. El Ayadi). New researchers will be encouraged to consult with the grant Investigators prior to drafting the proposal. To obtain a copy of the data, a researcher will have to: 1) Submit a request in writing identifying themselves and their affiliated institution; 2) Indicate title of their study, a brief rationale for the proposal, the methods of analysis, and the inclusion and exclusion criteria; 3) Include the approval of their Institutional Review Board/ Committee on Human Research; 4) Indicate what they plan to do with the data; 5) Include assurances that they will not share the data with others without the written permission of Dr. El Ayadi; 6) Commit to using the data only for research purposes; 7) Commit to securing the data using appropriate computer technology; 8) Commit to destroying or returning the data after analyses are completed, and; 9) Agree to give proper credit in any publications resulting from the data via citation of the grant and the investigators who obtained the data. Researchers will have to sign a Data Use Agreement that includes these terms, as well as a commitment that they will not attempt to identify individual respondents. Requests will be reviewed and acted on by the grant Steering Committee. After the Steering Committee approves a request for data, the PI will facilitate the preparation of the dataset that will be provided to the requestor. This dataset will be carefully screened to make certain that all identifying information has been removed (to the standards of the IRB).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 25/04/2023 Updated with actual trial start 15 Apr 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 25/04/2023 Updated based on actual trial start 24 Oct 2024 15 Apr 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 25/04/2023 Changed from not yet recruiting to recruiting Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/11/2024 Needed to add exclusion criteria that was missing (related to observed leakage being too small) Any rectovaginal fistula Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery. Any rectovaginal fistula Observed urinary leakage <6ml over 6 hours Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/11/2024 Expanded recruitment to additional sites Gynocare Womens and fistula hospital, Off Uganda road, Kahoya, PO BOX 2326-30100, Eldoret, 30100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/11/2024 Expanded recruitment to additional sites Infectious Disease Research Collaboration , Kampala Head Office Plot 2C Nakasero Hill Road, P.O. Box 7475 , Kampala , , Uganda