Recruiting

Hysterectomy vs. Uterine Preservation

Sponsor:

University of Calgary

Code:

NCT04890951

Conditions

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hysteropexy

Hysterectomy and vaginal vault suspension

Study Details

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.

Conditions

Pelvic Organ Prolapse

Study ID

NCT04890951

Start date

Jul 1, 2020

Status verified date

Apr, 2021

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have diagnosed POP of stage ≥2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q)
  • Elect surgical management of POP
  • Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction
  • Desire no further pregnancy
  • Can communicate in English
  • Are ≥18 years in age

Exclusion Criteria:

  • Prior hysterectomy

Study Design

Enrollment

321 participants

Anticipated

Interventions and Outcome Measures

Arms

Uterine Preservation

Hysterectomy

Interventions

Hysteropexy

Uterine preservation through suspension

Hysterectomy and vaginal vault suspension

Uterine removal and sewing the vagina upwards

Primary outcome measure

  • Anatomic failure to correct apical POP [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Pelvic Floor Clinic

Recruiting

Calgary, Alberta, Canada

Contacts

Natalie Scime, MSc

natalie.scime@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Jun 3, 2021

Last verified

Apr, 2021

Keywords

  • Pelvic Organ Prolapse
  • Gynecologic Surgery
  • Female
  • Epidemiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2021-06-03.