Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03414060
Status:
UNKNOWN
Last Update Posted:
2018-10-19
First Post:
2018-01-19
Brief Title:
Feasibility of the Menstrual Cup for VVF
Sponsor:
University of Ghana Medical School
Organization:
University of Ghana Medical School
Study Overview
Official Title:
Feasibility of the Menstrual Cup for Non-Surgical Management of VVF Among Women Seeking Care at a Health Facility in Ghana
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
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:
FMCVVF
Brief Summary:
This study examines the feasibility and acceptability of the vaginal menstrual cup for short-term management of vesicovaginal fistula VVF among 11 women seeking treatment at a health facility in Ghana The repeated measures design utilizes a 2-hr pad test to compare urinary leakage with and without the insertable cup a questionnaire on acceptability and perceived effect is administered and a clinical exam is completed Subsequently semi-structured interviews will be carried out with up to 24 additional women seeking treatment at a health facility in Ghana Interviews will cover womens experiences of living with fistula including strategies for coping with urinary incontinence and resulting stigma as well as user acceptability to the intervention
Detailed Description:
Vesicovaginal fistula VVF is a debilitating maternal morbidity that largely results from complications of prolonged obstructed labor when the trapped fetal head applies direct pressure to pelvicvaginal tissues and causes widespread ischemia tissue necrosis and subsequent extensive fistula formation Women living with VVF the most common anatomical presentation of obstetric fistula experience urinary incontinence which causes discomfort malodor and skin infection as well as social and psychological consequences that increase their vulnerability to the negative effects of stigma and reduce their quality of life
Traditional management requires surgical repair however many women either do not have access to surgery or access is delayed due to various individual social or structural barriers Non-surgical management previously explored with non-invasive techniques for residual urinary incontinence has been under-examined for fistula-related urinary incontinence The menstrual cup may be a useful option for non-surgical management of obstetric fistula Clinical and programmatic reports suggest a potential translation of the menstrual cup for collection or control of urine leakage in women with VVF however evidence has not been collected and examined systematically within a population in an endemic setting
While surgical management of fistula remains the gold standard in treatment research on non-surgical therapies is necessaryTherefore this study aims to assess the feasibility including efficacy safety and acceptability among users of using the menstrual cup over a short period among women seeking care for VVF in a clinical setting and unlike prior reports includes standardized measures of leakage and prioritizes user perspectives
A repeated measures design compared volume of leakage with the and without the cup to baseline leakage via a 2-hr pad test among women with VVF seeking surgical repair at a health facility in Ghana A questionnaire was later administered followed by a physical exam A paired t-test was used to analyze effect
Beginning October 2018 semi-structured interviews with up to 24 women seeking treatment at a health facility in Ghana will be carried out on womens experience with fistula including strategies for coping with urinary incontinence and resulting stigma as well as their acceptability to the insertable device This mixed methods approach is necessary to compare quantitative results and qualitative findings regarding what women are already doing to cope with incontinence and stigma and their acceptability to this device to manage leaking and support coping
Traditional management requires surgical repair however many women either do not have access to surgery or access is delayed due to various individual social or structural barriers Non-surgical management previously explored with non-invasive techniques for residual urinary incontinence has been under-examined for fistula-related urinary incontinence The menstrual cup may be a useful option for non-surgical management of obstetric fistula Clinical and programmatic reports suggest a potential translation of the menstrual cup for collection or control of urine leakage in women with VVF however evidence has not been collected and examined systematically within a population in an endemic setting
While surgical management of fistula remains the gold standard in treatment research on non-surgical therapies is necessaryTherefore this study aims to assess the feasibility including efficacy safety and acceptability among users of using the menstrual cup over a short period among women seeking care for VVF in a clinical setting and unlike prior reports includes standardized measures of leakage and prioritizes user perspectives
A repeated measures design compared volume of leakage with the and without the cup to baseline leakage via a 2-hr pad test among women with VVF seeking surgical repair at a health facility in Ghana A questionnaire was later administered followed by a physical exam A paired t-test was used to analyze effect
Beginning October 2018 semi-structured interviews with up to 24 women seeking treatment at a health facility in Ghana will be carried out on womens experience with fistula including strategies for coping with urinary incontinence and resulting stigma as well as their acceptability to the insertable device This mixed methods approach is necessary to compare quantitative results and qualitative findings regarding what women are already doing to cope with incontinence and stigma and their acceptability to this device to manage leaking and support coping
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