Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-27 @ 5:50 AM
Study NCT ID:
NCT00576004
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2007-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
Sponsor:
University Of Perugia
Organization:
Study Overview
Official Title:
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial
Status:
COMPLETED
Status Verified Date:
2007-12
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:
None
Brief Summary:
To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair
Detailed Description:
Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EC_ML_001s | None | None | View |