Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula in ghana: a randomized crossover trial
Active Project Grant Awarded Last action
- Award ID
- R01HD108236
- Recipient
-
The Regents Of The University Of California. San Francisco UEI KMH5K9V7S518
- Awarding agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Obligated
- $8,318,410
Award facts
- Assistance listing
- 93.865 Child Health and Human Development Extramural Research
- Completion date 95% complete
- Originally
- Place of performance
- San Francisco, CA 94143, USA
Award details come from USAspending.gov.
Description
- Abstract
- Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The 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. We 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 two fistula care centers in ghana 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.
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Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Africa Interdisciplinary Research Institute | $104,233 | |
| Subrecipient not on record | $115,292 | |
| College Of Health Sciences, University Of Ghana | $57,394 |
Quick answers
Who received award R01HD108236?
R01HD108236 was awarded to The Regents Of The University Of California. San Francisco by National Institute of Child Health and Human Development (National Institutes of Health) on April 1, 2022.
How much is award R01HD108236 worth?
$8,318,410 has been obligated on R01HD108236.
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