Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Uterine Preservation

Hysteropexy

Intervention Type PROCEDURE

Uterine preservation through suspension

Hysterectomy

Hysterectomy and vaginal vault suspension

Intervention Type PROCEDURE

Uterine removal and sewing the vagina upwards

Interventions

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Hysteropexy

Uterine preservation through suspension

Intervention Type PROCEDURE

Hysterectomy and vaginal vault suspension

Uterine removal and sewing the vagina upwards

Intervention Type PROCEDURE

Eligibility Criteria

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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