Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460434
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2007-04-13
Brief Title:
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Sponsor:
NICHD Pelvic Floor Disorders Network
Organization:
NICHD Pelvic Floor Disorders Network
Study Overview
Official Title:
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling OPUS Trial
Status:
COMPLETED
Status Verified Date:
2018-04
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:
OPUS
Brief Summary:
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30 Prolapse may be corrected by surgery using either a vaginal or abdominal incision Some women develop stress urinary incontinence SUI after surgery A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence however the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear Thus the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling OPUS trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape TVT at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence
Detailed Description:
The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence
The primary aims are
In stress continent women planning vaginal surgery for pelvic organ prolapse
1 To determine if the failure rate defined by subsequent treatment for urinary incontinence signs or symptoms of bothersome urinary incontinence defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory PFDI incontinence items differs between vaginal prolapse repair and vaginal prolapse repair plus TVT during the first 3 months after the index surgery
2 To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT whether or not there was subsequent treatment for symptoms of urinary incontinence ie to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT at the time of the prolapse surgery
3 To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life which will allow us to examine the cost-effectiveness of prophylactic use of a TVT at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery
The primary aims are
In stress continent women planning vaginal surgery for pelvic organ prolapse
1 To determine if the failure rate defined by subsequent treatment for urinary incontinence signs or symptoms of bothersome urinary incontinence defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory PFDI incontinence items differs between vaginal prolapse repair and vaginal prolapse repair plus TVT during the first 3 months after the index surgery
2 To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT whether or not there was subsequent treatment for symptoms of urinary incontinence ie to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT at the time of the prolapse surgery
3 To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life which will allow us to examine the cost-effectiveness of prophylactic use of a TVT at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery
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 |
|---|---|---|---|
| 2U01HD041249 | NIH | None | None |
| 2U10HD041250 | NIH | None | None |
| 2U10HD041261 | NIH | None | None |
| 2U10HD041267 | NIH | None | None |
| 1U10HD054214 | NIH | None | None |
| 1U10HD054136 | NIH | None | None |
| 1U10HD054215 | NIH | None | None |
| 1U10HD054241 | NIH | None | httpsreporternihgovquickSearch1U10HD054241 |