Clinical Trials Directory

Trials / Unknown

UnknownNCT04890951

Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study

Status
Unknown
Phase
Study type
Observational
Enrollment
321 (estimated)
Sponsor
University of Calgary · Academic / Other
Sex
Female
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREHysteropexyUterine preservation through suspension
PROCEDUREHysterectomy and vaginal vault suspensionUterine removal and sewing the vagina upwards

Timeline

Start date
2020-07-01
Primary completion
2023-12-01
Completion
2024-12-01
First posted
2021-05-18
Last updated
2021-06-03

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04890951. Inclusion in this directory is not an endorsement.