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Study identifier: NCT05444504 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

Condition: Obstetric Fistula · Fistula · Fistula, Urinary  ·  Sponsor: University of California, San Francisco

PhaseNA
Planned participants100
Who can joinFemale, 15 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nessa E Ryan, PhD  ·  17048062062  ·  ryann01@nyu.edu

Alison M El Ayadi, ScD  ·  6178777424  ·  alison.elayadi@ucsf.edu

Always discuss trial participation with your own doctor first.

Locations (3)

Mercy Women's Catholic HospitalMankessim, GhanaRecruiting
Tamale Fistula CenterTamale, GhanaRecruiting
Gynocare Women's and fistula hospitalEldoret, KenyaEnrolling By Invitation

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Source record: clinicaltrials.gov/study/NCT05444504