NCT05444504View on ClinicalTrials.gov

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 15, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

Conditions
Obstetric FistulaFistulaFistula, UrinaryFistula, 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

Trial Locations (3)

Unknown

RECRUITING

Mercy Women's Catholic Hospital, Mankessim

RECRUITING

Tamale Fistula Center, Tamale

ENROLLING_BY_INVITATION

Gynocare Women's and fistula hospital, Eldoret

All Listed Sponsors
collaborator

Korle-Bu Teaching Hospital, Accra, Ghana

OTHER

collaborator

Restore Health

UNKNOWN

collaborator

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

NIH

collaborator

Gynocare Women's and Fistula Hospital, Eldorat, Kenya

UNKNOWN

lead

University of California, San Francisco

OTHER