Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099372
Status:
TERMINATED
Last Update Posted:
2021-03-22
First Post:
2004-12-10
Brief Title:
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
Sponsor:
NICHD Pelvic Floor Disorders Network
Organization:
NICHD Pelvic Floor Disorders Network
Study Overview
Official Title:
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse The Extended Colpopexy and Urinary Reduction Efforts E-CARE Study
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
resource and prioritization change as Network transition to a new funding cycle
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-CARE
Brief Summary:
The Colpopexy and Urinary Reduction Effort CARE trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse POP affects the rates of urinary incontinence This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups Recruitment into this study is open only to women that already participated in CARE Recruitment into CARE is closed
Detailed Description:
The primary aims of this prospective cohort study are
1 To determine the long-term up to 10 years anatomic success rate of sacrocolpopexy defined as Stage 0 apical prolapse AND Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP and whether anatomic success differs between women who had vs those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy
2 To determine whether there is a difference in long-term stress continence by symptoms between women who had vs those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy
3 To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy
1 To determine the long-term up to 10 years anatomic success rate of sacrocolpopexy defined as Stage 0 apical prolapse AND Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP and whether anatomic success differs between women who had vs those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy
2 To determine whether there is a difference in long-term stress continence by symptoms between women who had vs those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy
3 To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy
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 |
|---|---|---|---|
| U10HD041267 | NIH | None | httpsreporternihgovquickSearchU10HD041267 |
| U01HD041249 | NIH | None | None |
| U10HD041268 | NIH | None | None |
| U10HD041248 | NIH | None | None |
| U10HD041250 | NIH | None | None |
| U10HD041261 | NIH | None | None |
| U10HD041263 | NIH | None | None |
| U10HD041269 | NIH | None | None |