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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

NCT05063331 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-15

No results posted yet for this study

Summary

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

Conditions

  • Uterine Prolapse

Interventions

PROCEDURE

Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)

Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.

PROCEDURE

Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • MetroHealth Medical Center

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Northwestern Medicine

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Adonis Hijaz, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063331 on ClinicalTrials.gov