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

University of Calgary

Status: Enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Hysterectomy and vaginal vault suspension; Procedure: Hysteropexy

Study type: Observational

Funder types: Other

Identifiers

NCT04890951

REB19-2134

Details and patient eligibility

About

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.

Enrollment: 321 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

321 participants in 2 patient groups

Uterine Preservation

Treatment:

Procedure: Hysteropexy

Hysterectomy

Treatment:

Procedure: Hysterectomy and vaginal vault suspension