VESICOVAGINAL FISTULA
Conditions
Interventions
Cup plus
Leaking freely
Sponsors
Korle Bu Teaching Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Any rectovaginal fistula Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in volume of observed urine leakage Urine leakage will be measured in mL using pad weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score Quality of life will be measured using the WHOQOL-BREF. The score ranges from 0-100 with higher scores indicating higher quality of life. ;Mean change in fistula-related stigma scale Stigma will be measured using the fistula-related stigma scale, and enacted and internalized subscales. This score ranges from 0-100 with higher scores indicating higher stigma.;Mean change in fistula management costs over time Fistula management costs will be calculated by combining the total material costs and lost wages in Ghanaian Cedi (local currency) over time. Time in minutes will inform calculations of lost wages using prevailing wage rates for the study population. The mean change in cost will be from baseline to 3 months.;Mean change in sleep satisfaction using the WHO sleep index Sleep satisfaction using the adapted WHO sleep index. The score ranges from 1-5 where 1 is least satisfied and 5 is very satisfied.;Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale Coping will be measured using the modified BRIEF Coping scale. The score ranges from 0-100 with higher scores indicating better coping.;Mean change in perceived empowerment over time Empowerment change in the proportion of users across physical mobility, participation in income-generating activities, bodily autonomy, household decision making, reproductive autonomy, and social participation. Individual measures will be captured using a scale of 1-5, with 1 indicating lower empowerment and 5 higher.;Changes in perceived safety over time change in the proportion of users who report any adverse events with use of the intervention model at 1, 2, and 3-month follow up;Changes in user acceptability of the intervention over time Proportion of users who report the intervention as acceptable measured across domains including easy to insert, remove, clean, comfortable to wear, interference with activities, perceived | — |
Countries
Ghana, Kenya, Uganda
Contacts
Public ContactNessa Ryan
Study Director
Outcome results
None listed