HUPPS: Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Uterine Preservation
|
Procedure: Hysteropexy
Uterine preservation through suspension
|
| Hysterectomy
|
Procedure: Hysterectomy and vaginal vault suspension
Uterine removal and sewing the vagina upwards
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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?"
- Length of surgery (minutes) [Peri-operative]
- Estimated blood loss during surgery >500 mL [Peri-operative]
- Procedural complications [Peri-operative]
E.g., peri-operative blood transfusion, visceral injury
- Post-operative infection [Peri-operative]
E.g., abscess, urinary tract infection
- Opioid use in-hospital [Peri-operative]
Measured by Morphine milliequivalent (mEq)
- 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 [6 weeks; 1 year]
Change from baseline
- PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score [6 weeks; 1 year]
Change from baseline
- PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score [6 weeks; 1 year]
Change from baseline
- 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)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pelvic Floor Clinic | Calgary | Alberta | Canada |
Sponsors and Collaborators
- University of Calgary
- Canadian Institutes of Health Research (CIHR)
- The MSI Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REB19-2134