Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

University of Calgary321 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

321

Conditions

Pelvic Organ Prolapse

Interventions

HysteropexyPROCEDURE

Uterine preservation through suspension

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Anatomic failure to correct apical POP

Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length

Time frame: 1 year

Secondary Outcomes

Overall failure to correct POP

POP-Q stage ≥2 in any compartment, or re-treatment of POP with physiotherapy, pessary, or repeat surgery

Time frame: 1 year

Subjective failure to correct POP

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?"

Time frame: 6 weeks; 1 year

Length of surgery (minutes)

Time frame: Peri-operative

Estimated blood loss during surgery >500 mL

Time frame: Peri-operative

Procedural complications

E.g., peri-operative blood transfusion, visceral injury

Time frame: Peri-operative

Post-operative infection

E.g., abscess, urinary tract infection

Time frame: Peri-operative

Opioid use in-hospital

Measured by Morphine milliequivalent (mEq)

Time frame: Peri-operative

Resumption of spontaneous voiding (days)

Time frame: Peri-operative

Length of post-operative stay (days)

Time frame: Peri-operative

PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score

Change from baseline

Time frame: 6 weeks; 1 year

PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score

Change from baseline

Time frame: 6 weeks; 1 year

PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score

Change from baseline

Time frame: 6 weeks; 1 year

Presentation at the emergency department

Time frame: 30 days (any health complaint); 1 year (pelvic floor-related complaint)

Hospital readmission

Time frame: 30 days (any health complaint); 1 year (pelvic floor-related complaint)

Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts