Clinical trial NCT04890951: Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery
Official title: Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic Organ Prolapse
Gynecologic Surgery
Female
Epidemiology
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The MSI Foundation
First posted: 2021-05-18
Enrollment: 321
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women seeking surgical correction of POP at one of the study sites.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anatomic failure to correct apical POP
timeFrame: 1 year
Secondary outcomes:
measure: Overall failure to correct POP
timeFrame: 1 year
measure: Subjective failure to correct POP
timeFrame: 6 weeks; 1 year
measure: Length of surgery (minutes)
timeFrame: Peri-operative
measure: Estimated blood loss during surgery >500 mL
timeFrame: Peri-operative
measure: Procedural complications
timeFrame: Peri-operative
measure: Post-operative infection
timeFrame: Peri-operative
measure: Opioid use in-hospital
timeFrame: Peri-operative
measure: Resumption of spontaneous voiding (days)
timeFrame: Peri-operative
measure: Length of post-operative stay (days)
timeFrame: Peri-operative
measure: PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score
timeFrame: 6 weeks; 1 year
measure: PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score
timeFrame: 6 weeks; 1 year
measure: PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score
timeFrame: 6 weeks; 1 year
measure: Presentation at the emergency department
timeFrame: 30 days (any health complaint); 1 year (pelvic floor-related complaint)
measure: Hospital readmission
timeFrame: 30 days (any health complaint); 1 year (pelvic floor-related complaint)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pelvic Floor Clinic
state: Alberta
Study officials:
References:
citation: Scime NV, Ramage K, Brennand EA; Calgary Women's Pelvic Health Research Group. Protocol for a prospective multisite cohort study investigating hysterectomy versus uterine preservation for pelvic organ prolapse surgery: the HUPPS study. BMJ Open. 2021 Oct 4;11(10):e053679. doi: 10.1136/bmjopen-2021-053679.