Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Hysterectomy and vaginal vault suspension; Procedure: Hysteropexy

• Registration Number: NCT04890951
• Lead Sponsor: University of Calgary

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

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-04
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-18
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-03
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 321

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

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Exclusion Criteria

• Prior hysterectomy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hysterectomy	Hysterectomy and vaginal vault suspension	-
Uterine Preservation	Hysteropexy	-

Primary Outcome Measures

Name	Time	Method
Anatomic failure to correct apical POP	1 year	Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length

Secondary Outcome Measures

Name	Time	Method
Length of post-operative stay (days)	Peri-operative
Estimated blood loss during surgery >500 mL	Peri-operative
Opioid use in-hospital	Peri-operative	Measured by Morphine milliequivalent (mEq)
Resumption of spontaneous voiding (days)	Peri-operative
Subjective failure to correct POP	6 weeks; 1 year	Patient report of bulge symptoms at 6 weeks or 1 year, using one item on the PFDI-20: "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
Overall failure to correct POP	1 year	POP-Q stage ≥2 in any compartment, or re-treatment of POP with physiotherapy, pessary, or repeat surgery
Length of surgery (minutes)	Peri-operative
Procedural complications	Peri-operative	E.g., peri-operative blood transfusion, visceral injury
PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score	6 weeks; 1 year	Change from baseline
Hospital readmission	30 days (any health complaint); 1 year (pelvic floor-related complaint)
Post-operative infection	Peri-operative	E.g., abscess, urinary tract infection
PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score	6 weeks; 1 year	Change from baseline
Presentation at the emergency department	30 days (any health complaint); 1 year (pelvic floor-related complaint)
PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score	6 weeks; 1 year	Change from baseline

Trial Locations

Locations (1)

Pelvic Floor Clinic; 🇨🇦 Calgary, Alberta, Canada