Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065845
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2003-08-01
Brief Title:
Colpopexy and Urinary Reduction Efforts CARE Protocol
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
CARE A Randomized Trial of Colpopexy and Urinary Reduction Efforts
Status:
COMPLETED
Status Verified Date:
2010-10
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:
CARE
Brief Summary:
Pelvic organ prolapse occurs when the muscles holding pelvic organs eg the uterus or bladder weaken and the organs fall or slide down into the vagina Pelvic organ prolapse can be corrected with surgery However women who have this surgery may develop urinary incontinence This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence
Detailed Description:
Many women have surgery for pelvic organ prolapse cystocele uterine prolapse rectocele Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse Development of incontinence is unpredictable This study will determine which if any clinical tests are useful for predicting post-operative urinary incontinence The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women
Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group Women in the Burch group will undergo urethropexy at the time of prolapse repair Assessments will include a quality of life telephone interview urodynamic testing and physical examination Follow-up evaluations occur at 6 weeks 3 months and 1 and 2 years following surgery Post-operative phone interviews will occur at 3 months 6 months and 1 and 2 years
Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group Women in the Burch group will undergo urethropexy at the time of prolapse repair Assessments will include a quality of life telephone interview urodynamic testing and physical examination Follow-up evaluations occur at 6 weeks 3 months and 1 and 2 years following surgery Post-operative phone interviews will occur at 3 months 6 months and 1 and 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HD041268 | NIH | None | None |
| U10HD041248 | NIH | None | None |
| U10HD041250 | NIH | None | None |
| U10HD041261 | NIH | None | None |
| U10HD041263 | NIH | None | None |
| U10HD041269 | NIH | None | None |
| U10HD041267 | NIH | None | httpsreporternihgovquickSearchU10HD041267 |