Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

  • STATUS
    Recruiting
  • End date
    Dec 13, 2024
  • participants needed
    321
  • sponsor
    University of Calgary
Updated on 13 June 2021
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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.

Details
Condition Vaginal Vault Prolapse, Genitourinary Prolapse, Ptosis, pelvic organ prolapse
Treatment Hysteropexy, Hysterectomy and vaginal vault suspension
Clinical Study IdentifierNCT04890951
SponsorUniversity of Calgary
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

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
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