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
(n30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health
workers, n20).
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.