Feasibility of the Menstrual Cup for VVF

NCT03414060 | Completed

• 1 other identifier: CHS-Et/M.9-P3.2/2015-2016
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obstetric fistula; vesicovaginal fistula; menstrual cup; pad test; non-surgical management; feasibility; acceptability; innovation; coping; incontinence

Outcome Measures

Primary Outcomes (1)

• Volume of urinary leakage (in ml)

  Measured by 2-hr pad test

  Over 2 hours

Secondary Outcomes (5)

• Acceptability of the menstrual cup

  Over 2 hours

• Adverse events

  Over 2 hours

• Rate of enrollment through study completion

  through study completion, an average of 1 year

• Rate of consent through study completion

  through study completion, an average of 1 year

• Perceived assessment of leakage with use of the menstrual cup

  After 1 hour of use

Study Arms (1)

Intervention (Menstrual Cup)

EXPERIMENTAL

The menstrual cup is a 100% silicone, flexible reservoir cup that, when inserted correctly in the vagina, is sanitary and efficacious in preventing leakage of menstrual blood and in eliminating odor.

Device: Menstrual Cup

Interventions

Menstrual Cup DEVICE

Intervention (Menstrual Cup)

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:

• Patient seeking surgical repair for VVF
• VVF confirmed by gynecologic examination
• Adequate vaginal capacity to accommodate the menstrual cup
• Fistula high in vagina (determined at gynecologic examination)
• Willingness to insert and remove the device by one's self

You may not qualify if:

• Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)
• Unable or unwilling to learn to insert and remove the menstrual cup
• Patient who declines consent or is incapable of consent
• Presence of rectovaginal fistula (RVF) or combined RVF and VVF
• Fistula low in the vagina precluding collection of urine by the menstrual cup

Sponsors & Collaborators

• New York University: collaborator
• University of Ghana Medical School: lead
• NYU Langone Health: collaborator
• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator

Study Sites (1)

Mercy Women's Catholic Hospital

Mankessim, Central Region, Ghana

Location

MeSH Terms

Conditions

Vaginal Fistula; Vesicovaginal Fistula; Wounds and Injuries

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Fistula; Urinary Fistula; Urogenital Abnormalities; Urinary Bladder Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Gabriel YK Ganyaglo, MD

  Korle-Bu Teaching Hospital, Accra, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: repeated measures

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 29, 2018
• Study Start: August 8, 2016
• Primary Completion: December 2, 2016
• Study Completion: December 2, 2016
• Last Updated: May 5, 2026

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data are available through the publication indefinitely.
• Access Criteria: Publication is posted in an open access journal.

Locations

GH (1)