Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula: protocol for a hybrid type I randomized crossover trial.

Background: Obstetric fistula is a traumatic and stigmatized maternal morbidity often resulting in severe urinary and fecal incontinence. Women with fistula face multi-level barriers to surgical repair culminating in delays. Unfortunately, no acceptable temporizing measures to contain incontinence of urine exists. An insertable vaginal cup, alone or connected to a leg bag, has potential for improving incontinence management for women awaiting surgery or those whom surgery was unsuccessful, but effectiveness and acceptability are unknown.

Methods: We describe a four-year clinical trial and nested qualitative study to examine the effectiveness and acceptability of an insertable vaginal cup to manage fistula urinary incontinence and understand fistula management costs. Two intervention models will be compared to a control: (1) vaginal cup ('cup'), and (2) vaginal cup attached via tubing to a leg-secured urine collection bag ('cup+'). Using a cross-over design, up to 100 participants will be block randomized to one of two sequences of leaking freely (no intervention), cup, and cup + at four fistula centers in Ghana and Kenya and observed for four days (400 total observations). Data will be captured through interviewer-administered survey, clinical exam and checklist. After clinic-based assessment, participants are individually randomized for cup or cup + for home use for up to 3 months and surveyed monthly. Effectiveness will be evaluated through quantitative comparison of urinary leakage (6 h and 24 h) and patient-reported quality of life (1-3 months) between cup, cup+, and leaking freely. Acceptability will be assessed quantitatively (1-3 months) and via in-depth interview among selected trial participants (n ~ 30) and potential implementers (n ~ 20).

Discussion: This implementation study will inform the effectiveness and acceptability of the cup and cup + interventions as temporizing management strategies for fistula urinary incontinence. If the cup/cup + is effective and acceptable, this study will provide insight for future trials and cost-effective assessments in settings where fistula is prevalent. Expanding the evidence base on non-surgical temporizing management options will inform comprehensive fistula care through tertiary prevention and is likely to reduce vulnerability to stigma and improve economic opportunity and quality of life.

Trial registrations and dates: ClinicalTrials.gov NCT05444504 (Date of registration: July 6, 2022). Pan African Clinical Trial Registry 202,209,466,217,416 (Date of registration: 9/22/2022). Ghana FDA Certificate FDA/CT/231 (Date of approval: 3/30/2023).