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Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

NCT04890951 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 321

Last updated 2021-06-03

No results posted yet for this study

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

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Hysteropexy

Uterine preservation through suspension

PROCEDURE

Hysterectomy and vaginal vault suspension

Uterine removal and sewing the vagina upwards

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The MSI Foundation

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890951 on ClinicalTrials.gov