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Feasibility of the Menstrual Cup for VVF

NCT03414060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-05-05

No results posted yet for this study

Summary

This study examines the feasibility and acceptability of the vaginal menstrual cup for short-term management of vesicovaginal fistula (VVF) among 11 women seeking treatment at a health facility in Ghana. The repeated measures design utilizes a 2-hr pad test to compare urinary leakage with and without the insertable cup, a questionnaire on acceptability and perceived effect is administered and a clinical exam is completed. Subsequently, semi-structured interviews will be carried out with up to 24 additional women seeking treatment at a health facility in Ghana. Interviews will cover women's experiences of living with fistula, including strategies for coping with urinary incontinence and resulting stigma, as well as user acceptability to the intervention.

Conditions

  • Vaginal Fistula
  • Vesico Vaginal Fistula
  • Obstetric; Injury

Interventions

DEVICE

Menstrual Cup

Sponsors & Collaborators

  • New York University

    collaborator OTHER

  • NYU Langone Health

    collaborator OTHER

  • Korle-Bu Teaching Hospital, Accra, Ghana

    collaborator OTHER

  • University of Ghana Medical School

    lead OTHER

Principal Investigators

  • Gabriel YK Ganyaglo, MD · Korle-Bu Teaching Hospital, Accra, Ghana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-08
Primary Completion
2016-12-02
Completion
2016-12-02

Countries

  • Ghana

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 NCT03414060 on ClinicalTrials.gov