Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT04890951
Status:
UNKNOWN
Last Update Posted:
2021-06-03
First Post:
2021-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study
Status:
UNKNOWN
Status Verified Date:
2021-04
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:
HUPPS
Brief Summary:
Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: