Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

NCT05444504 | Recruiting DMC

• 2 other identifiers: P0555006R01HD108236
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief 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

Fistula, Vaginal; Obstetric Fistula; Fistula; Fistula, Urinary

Keywords

Menstrual cup; Urinary incontinence; Fistula; Obstetric Fistula; Fistula, Vaginal; Fistula, Urinary; Women's health; Quality of LIfe

Outcome Measures

Primary Outcomes (1)

• Mean change in volume of observed urine leakage

  Urine leakage will be measured in mL using pad weight

  baseline to 6 hours

Secondary Outcomes (10)

• Mean change in volume of perceived urine leakage

  baseline vs. 6 hours, 24 hours,1 month, 2 months and 3 months

• Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score

  baseline vs. 24 hours, 1 month, 2 months and 3 months

• Mean change in fistula-related stigma scale

  baseline vs. 1 month, 2 months and 3 months

• Mean change in fistula management costs over time

  baseline vs. 1 month, 2 months, and 3 months

• Mean change in sleep satisfaction using the WHO sleep index

  baseline vs. 1 month, 2 months, and 3 months

Study Arms (2)

Group 1

OTHER

24 hours of use each of leaking freely, leaking freely, cup, and then cup+

Device: Cup; Device: Cup+

Group 2

OTHER

24 hours of use each of leaking freely, cup, cup+, and then cup

Device: Cup; Device: Cup+

Interventions

Cup+ DEVICE

the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity

Group 1; Group 2

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Gynocare Women's and Fistula Hospital, Eldorat, Kenya: collaborator
• University of California, San Francisco: lead
• Restore Health: collaborator

Study Sites (3)

Mercy Women's Catholic Hospital

Mankessim, Ghana

RECRUITING

Tamale Fistula Center

Tamale, Ghana

RECRUITING

Gynocare Women's and fistula hospital

Eldoret, Kenya

ENROLLING BY INVITATION

Related Publications (52)

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MeSH Terms

Conditions

Fistula; Urinary Fistula; Vaginal Fistula; Urinary Incontinence

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vaginal Diseases; Genital Diseases, Female; Genital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Alison El Ayadi, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nessa Ryan, PhD

  Restore Health

  STUDY DIRECTOR

Central Study Contacts

Nessa E Ryan, PhD

CONTACT

17048062062; ryann01@nyu.edu

Alison M El Ayadi, ScD

CONTACT

6178777424; alison.elayadi@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 6, 2022
• Study Start: April 15, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after primary and secondary analyses have been completed.
• Access Criteria: Data access requests should include 1) Indicate title of their study, a brief rationale for the proposal, the methods of analysis, and the inclusion and exclusion criteria; 2) Include the approval of their Institutional Review Board/ Committee on Human Research; 3) Indicate what they plan to do with the data; 4) Include assurances that they will not share the data with others without the written permission of Dr. El Ayadi; 5) Commit to using the data only for research purposes; 6) Commit to securing the data using appropriate computer technology; 7) Commit to destroying or returning the data after analyses are completed, and; 8) Agree to give proper credit in any publications resulting from the data via citation of the grant and the investigators who obtained the data. Researchers will have to sign a Data Use Agreement that includes these terms, as well as a commitment that they will not attempt to identify individual respondents.

Locations

GH (2); KE (1)