Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management (COPE)

December 21, 2023 updated by: University of California, San Francisco

Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula in Ghana: a Randomized Crossover Trial

The investigators 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The estimated two million women with fistula, most in sub-Saharan Africa, face substantial multi-level barriers to surgical repair. Women need an acceptable non-surgical option for therapeutic management of fistula-related urinary incontinence, yet no non-surgical standard of care exists. Use of an insertable silicone vaginal cup has great potential for fistula management; it is effective for menstrual management and efficacious at reducing short-term fistula urinary leakage.

The investigators 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. Using a cross-over design for efficiency, 100 participants will be randomized to one of two sequences of leaking freely, cup, and cup+ at two fistula care centers in Ghana and observed for four days (total observations=400). Each treatment (cup, cup+ or leaking freely) is used for 24h for day and night use, then crossover. Data are captured through self-report and clinical checklist. On day 4, participants are re-randomized to use cup or cup+ at home for 3 months. Acceptability assessment is informed by implementation and health behavior theory.

Aim 1. To quantify the effectiveness and comparative effectiveness of the cup and cup+. The trial will compare objective and patient-reported measures of effectiveness of the cup and cup+ to leaking freely and of the cup to the cup+. Short-term assessment will be objective (urinary leakage; 8, 24hrs), long-term assessment will be patient-reported (QoL; 1-3 months).

Aim 2. To examine acceptability of cup and cup+. User and implementer acceptability will be assessed using a sequential explanatory mixed-methods design. Acceptability among trial participants will be measured longitudinally (1-3 months). User and implementer acceptability will be examined within in-depth interviews of selected trial participants (n~30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health workers, n~20).

Aim 3. To explore the material and opportunity costs to non-surgical fistula management. Surveys and time motion study among trial participants at facility and community will estimate direct and indirect costs of fistula management from a patient perspective. The long-term goal of the proposed work is to overcome barriers to comprehensive fistula care and increase quality of life through an acceptable, non-surgical option for therapeutic management of fistula.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ghana
      • Mankesim, Ghana
        • Recruiting
        • Mercy Women's Catholic Hospital
        • Contact:
        • Principal Investigator:
          • Gabriel Ganyaglo, MBChB
      • Tamale, Ghana
        • Recruiting
        • Tamale Fistula Center
        • Principal Investigator:
          • Gabriel Ganyaglo, MBChB
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • Any rectovaginal fistula
  • Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
24 hours of use each of leaking freely, leaking freely, cup, and then cup+
Device: Cup
an insertable vaginal cup ('cup')
Device: Cup+
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Other: Group 2
24 hours of use each of leaking freely, cup, cup+, and then cup
Device: Cup
an insertable vaginal cup ('cup')
Device: Cup+
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in volume of observed urine leakage
Time Frame: baseline to 8 hours
Urine leakage will be measured in mL using pad weight
baseline to 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in volume of perceived urine leakage
Time Frame: baseline vs. 8 hours, 24 hours,1 month, 2 months and 3 months
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
Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score
Time Frame: baseline vs. 24 hours, 1 month, 2 months and 3 months
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
Mean change in fistula-related stigma scale
Time Frame: baseline vs. 1 month, 2 months and 3 months
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
Mean change in fistula management costs over time
Time Frame: baseline vs. 1 month, 2 months, and 3 months
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
Mean change in sleep satisfaction using the WHO sleep index
Time Frame: baseline vs. 1 month, 2 months, and 3 months
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
Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale
Time Frame: baseline vs. 1 month, 2 months, and 3 months
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
Mean change in perceived empowerment over time
Time Frame: baseline vs. 1 month, 2 months, and 3 months
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
Changes in perceived safety over time
Time Frame: baseline vs. 8 hours, 24 hours, 1 month, 2 months, and 3 months
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
Changes in user acceptability of the intervention over time
Time Frame: 8 hours vs. 24 hours, 1 month, 2 months, and 3 months
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
Changes in post-fistula repair reintegration scale
Time Frame: baseline vs. 1 month, 2 months, and 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Korle-Bu Teaching Hospital, Accra, Ghana
Restore Health

Investigators

  • Study Director: Nessa Ryan, PhD, Restore Health
  • Principal Investigator: Alison El Ayadi, ScD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0555006
  • R01HD108236 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Quantitative data will be deidentified and made available after all study publications have been completed without cost to researchers and analysts. Qualitative data and associated documentation will be available to users under a data-sharing agreement.

IPD Sharing Time Frame

Data will be available after primary and secondary analyses have been completed.

IPD Sharing Access Criteria

Data access requests should include 1) Indicate title of their study, a brief rationale for the proposal, the methods of analysis, and the inclusion and exclusion criteria; 2) Include the approval of their Institutional Review Board/ Committee on Human Research; 3) Indicate what they plan to do with the data; 4) Include assurances that they will not share the data with others without the written permission of Dr. El Ayadi; 5) Commit to using the data only for research purposes; 6) Commit to securing the data using appropriate computer technology; 7) Commit to destroying or returning the data after analyses are completed, and; 8) 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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