Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05444504
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2022-06-23
Brief Title:
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula in Ghana a Randomized Crossover Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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 two fistula care centers in Ghana and observed for four days total observations400 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 obgyns midwivesnurses 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
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 two fistula care centers in Ghana and observed for four days total observations400 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 obgyns midwivesnurses 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD108236 | NIH | None | httpsreporternihgovquickSearchR01HD108236 |