Clinical trial NCT05444504: Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Official title: Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstetric Fistula
Fistula
Fistula, Urinary
Fistula, Vaginal
Keywords: Menstrual cup
Urinary incontinence
Fistula
Obstetric Fistula
Fistula, Vaginal
Fistula, Urinary
Women's health
Quality of LIfe
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Korle-Bu Teaching Hospital, Accra, Ghana
name: Restore Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Gynocare Women's and Fistula Hospital, Eldorat, Kenya
First posted: 2022-07-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The estimated two million women with fistula, most in sub-Saharan Africa, face substantial multi-level barriers to surgical repair. Women need an acceptable non-surgical option for therapeutic management of fistula-related urinary incontinence, yet no non-surgical standard of care exists. Use of an insertable silicone vaginal cup has great potential for fistula management; it is effective for menstrual management and efficacious at reducing short-term fistula urinary leakage.

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. Using a cross-over design for efficiency, 100 participants will be randomized to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda and observed for four days (total observations=400). Each treatment (cup, cup+ or leaking freely) is used for 24h for day and night use, then crossover. Data are captured through self-report and clinical checklist. On day 4, participants are re-randomized to use cup or cup+ at home for 3 months. Acceptability assessment is informed by implementation and health behavior theory.

Aim 1. To quantify the effectiveness and comparative effectiveness of the cup and cup+. The trial will compare objective and patient-reported measures of effectiveness of the cup and cup+ to leaking freely and of the cup to the cup+. Short-term assessment will be objective (urinary leakage; 8, 24hrs), long-term assessment will be patient-reported (QoL; 1-3 months).

Aim 2. To examine acceptability of cup and cup+. User and implementer acceptability will be assessed using a sequential explanatory mixed-methods design. Acceptability among trial participants will be measured longitudinally (1-3 months). User and implementer acceptability will be examined within in-depth interviews of selected trial participants (n\~30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health workers, n\~20).

Aim 3. To explore the material and opportunity costs to non-surgical fistula management. Surveys and time motion study among trial participants at facility and community will estimate direct and indirect costs of fistula management from a patient perspective. The long-term goal of the proposed work is to overcome barriers to comprehensive fistula care and increase quality of life through an acceptable, non-surgical option for therapeutic management of fistula.

Eligibility 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:

* 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.

Primary outcomes:
measure: Mean change in volume of observed urine leakage
timeFrame: baseline to 6 hours
Secondary outcomes:
measure: Mean change in volume of perceived urine leakage
timeFrame: baseline vs. 6 hours, 24 hours,1 month, 2 months and 3 months
measure: Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score
timeFrame: baseline vs. 24 hours, 1 month, 2 months and 3 months
measure: Mean change in fistula-related stigma scale
timeFrame: baseline vs. 1 month, 2 months and 3 months
measure: Mean change in fistula management costs over time
timeFrame: baseline vs. 1 month, 2 months, and 3 months
measure: Mean change in sleep satisfaction using the WHO sleep index
timeFrame: baseline vs. 1 month, 2 months, and 3 months
measure: Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale
timeFrame: baseline vs. 1 month, 2 months, and 3 months
measure: Mean change in perceived empowerment over time
timeFrame: baseline vs. 1 month, 2 months, and 3 months
measure: Changes in perceived safety over time
timeFrame: baseline vs. 6 hours, 24 hours, 1 month, 2 months, and 3 months
measure: Changes in user acceptability of the intervention over time
timeFrame: 6 hours vs. 24 hours, 1 month, 2 months, and 3 months
measure: Changes in post-fistula repair reintegration scale
timeFrame: baseline vs. 1 month, 2 months, and 3 months
Other outcomes:
Locations:
city: Mankesim
country: Ghana
facility: Mercy Women's Catholic Hospital
city: Tamale
country: Ghana
facility: Tamale Fistula Center
city: Eldoret
country: Kenya
facility: Gynocare Women's and fistula hospital
Study officials:
affiliation: University of California, San Francisco
name: Alison El Ayadi, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Restore Health
name: Nessa Ryan, PhD
role: STUDY_DIRECTOR
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