Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
NCT ID: NCT05444504
Last Updated: 2025-12-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-04-15
Study Completion Date
2027-01-01
Brief Summary
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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.
Detailed Description
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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 fistula centers in Ghana, Kenya, and Uganda 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.
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 fistula centers in Ghana, Kenya, and Uganda 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.
Conditions
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Obstetric Fistula
Fistula
Fistula, Urinary
Fistula, Vaginal
Keywords
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Menstrual cup
Urinary incontinence
Fistula
Obstetric Fistula
Fistula, Vaginal
Fistula, Urinary
Women's health
Quality of LIfe
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
The investigators will compare two intervention models 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 (Table 1). Using a crossover design for efficiency, the investigators will randomize 100 participants to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda, then re-randomize to continue using the cup or cup+ at home for up to 3 months. This design includes repeated measures of leakage (4 per participant, total obs=400), uses participants as their own controls, reduces the risk of confounding due to intervention order, and captures usual leaking variability through multiple measures.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Group 1
24 hours of use each of leaking freely, leaking freely, cup, and then cup+
Group Type
OTHER
Cup
Intervention Type
DEVICE
an insertable vaginal cup ('cup')
Cup+
Intervention Type
DEVICE
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Group 2
24 hours of use each of leaking freely, cup, cup+, and then cup
Group Type
OTHER
Cup
Intervention Type
DEVICE
an insertable vaginal cup ('cup')
Cup+
Intervention Type
DEVICE
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Interventions
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Cup
an insertable vaginal cup ('cup')
Intervention Type
DEVICE
Cup+
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* 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.
* 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.
Minimum Eligible Age
15 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Korle-Bu Teaching Hospital, Accra, Ghana
OTHER
Sponsor Role
collaborator
Restore Health
UNKNOWN
Sponsor Role
collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Gynocare Women's and Fistula Hospital, Eldorat, Kenya
UNKNOWN
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alison El Ayadi, ScD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Nessa Ryan, PhD
Role: STUDY_DIRECTOR
Restore Health
Locations
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Mercy Women's Catholic Hospital
Mankessim, , Ghana
Site Status
RECRUITING
Tamale Fistula Center
Tamale, , Ghana
Site Status
RECRUITING
Gynocare Women's and fistula hospital
Eldoret, , Kenya
Site Status
ENROLLING_BY_INVITATION
Countries
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Uganda
Ghana
Kenya
Central Contacts
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Facility Contacts
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Dr. Gabriel Ganyaglo, MBChB
Role: primary
Gabriel Ganyaglo, MBChB
Role: primary
References
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DERIVED
Other Identifiers
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P0555006
Identifier Type: -
Identifier Source: org_study_id