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Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

NCT05444504 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-22

No results posted yet for this study

Summary

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.

Conditions

  • Obstetric Fistula
  • Fistula
  • Fistula, Urinary
  • Fistula, Vaginal

Interventions

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

Sponsors & Collaborators

  • Korle-Bu Teaching Hospital, Accra, Ghana

    collaborator OTHER

  • Restore Health

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Gynocare Women's and Fistula Hospital, Eldorat, Kenya

    collaborator UNKNOWN

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Alison El Ayadi, ScD · University of California, San Francisco

  • Nessa Ryan, PhD · Restore Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2026-10-01
Completion
2027-01-01

Countries

  • Ghana
  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444504 on ClinicalTrials.gov