Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

— HUPPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890951
• Other study ID #: REB19-2134
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2021
• Source: University of Calgary
• Contact: Erin A Brennand, MD
• Phone: 403-944-1636
• Email: Erin.brennand[@]albertahealthservices.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 321
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Hysteropexy
Uterine preservation through suspension
• Hysterectomy and vaginal vault suspension
Uterine removal and sewing the vagina upwards

Locations

Country	Name	City	State
Canada	Pelvic Floor Clinic	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), The MSI Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Length of surgery (minutes)		Peri-operative
Secondary	Estimated blood loss during surgery >500 mL		Peri-operative
Secondary	Procedural complications	E.g., peri-operative blood transfusion, visceral injury	Peri-operative
Secondary	Post-operative infection	E.g., abscess, urinary tract infection	Peri-operative
Secondary	Opioid use in-hospital	Measured by Morphine milliequivalent (mEq)	Peri-operative
Secondary	Resumption of spontaneous voiding (days)		Peri-operative
Secondary	Length of post-operative stay (days)		Peri-operative
Secondary	PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score	Change from baseline	6 weeks; 1 year
Secondary	PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score	Change from baseline	6 weeks; 1 year
Secondary	PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score	Change from baseline	6 weeks; 1 year
Secondary	Presentation at the emergency department		30 days (any health complaint); 1 year (pelvic floor-related complaint)
Secondary	Hospital readmission		30 days (any health complaint); 1 year (pelvic floor-related complaint)