Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery (HUPPS)

Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study

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 Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Hysteropexy; Procedure: Hysterectomy and vaginal vault suspension

• Study Type: Observational
• Enrollment (Anticipated): 321

Contacts and Locations

• Study Contact: Name: Erin A Brennand, MD; Phone Number: 403-944-1636; Email: Erin.brennand@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Pelvic Floor Clinic
      • Contact: Natalie Scime, MSc; Email: natalie.scime@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women seeking surgical correction of POP at one of the study sites.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uterine Preservation	Procedure: Hysteropexy; Uterine preservation through suspension
Hysterectomy	Procedure: Hysterectomy and vaginal vault suspension; Uterine removal and sewing the vagina upwards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall failure to correct POP	POP-Q stage ≥2 in any compartment, or re-treatment of POP with physiotherapy, pessary, or repeat surgery	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?"	6 weeks; 1 year
Length of surgery (minutes)		Peri-operative
Estimated blood loss during surgery >500 mL		Peri-operative
Procedural complications	E.g., peri-operative blood transfusion, visceral injury	Peri-operative
Post-operative infection	E.g., abscess, urinary tract infection	Peri-operative
Opioid use in-hospital	Measured by Morphine milliequivalent (mEq)	Peri-operative
Resumption of spontaneous voiding (days)		Peri-operative
Length of post-operative stay (days)		Peri-operative
PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score	Change from baseline	6 weeks; 1 year
PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score	Change from baseline	6 weeks; 1 year
PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score	Change from baseline	6 weeks; 1 year
Presentation at the emergency department		30 days (any health complaint); 1 year (pelvic floor-related complaint)
Hospital readmission		30 days (any health complaint); 1 year (pelvic floor-related complaint)

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR); The MSI Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Epidemiology; Female; Pelvic Organ Prolapse; Gynecologic Surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: REB19-2134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No