Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
PREMIER
Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
1 other identifier
interventional
300
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
May 15, 2026
October 1, 2025
7.5 years
August 4, 2021
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment failure
The primary outcome is treatment failure defined as the presence of at least one of the following: 1) presence of a vaginal bulge defined as lead point of prolapse beyond the hymen, 2) report of bothersome vaginal bulge symptoms irrespective of stage of prolapse, or 3) retreatment of symptomatic prolapse with pessary, or surgery.
36 months post-surgery
Secondary Outcomes (14)
Postoperative pain medication use
Post-surgery through Day 14
Change in surgical pain using VAS
Baseline, Days 1, 7 and 14 post-surgery
Postoperative anti-emetic use
Post-surgery through Day 14
Change in nausea using VAS
Baseline, Days 1, 7 and 14 post-surgery
Change in fatigue using MAF
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
- +9 more secondary outcomes
Study Arms (2)
Sacrocolpopexy
ACTIVE COMPARATORMinimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)
Uterosacral Ligament Suspension
ACTIVE COMPARATORTotal vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Interventions
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.
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
Eligibility Criteria
You may qualify if:
- Women ≥ 18 years of age and ≤ 80 years of age
- Have diagnosis of symptomatic uterovaginal prolapse
- Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
- Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
You may not qualify if:
- Patients who wish to undergo uterine sparing procedures
- Body mass index BMI) \> 50
- Previous hysterectomy or prior uterovaginal surgery
- Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
- Chronic indwelling urinary catheter
- Urinary diversion of any type
- Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
- Unable to speak, read, understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitycollaborator
- MetroHealth Medical Centercollaborator
- The Cleveland Cliniccollaborator
- Duke Universitycollaborator
- University of Pittsburghcollaborator
- Mayo Cliniccollaborator
- Northwestern Medicinecollaborator
- University Hospitals Cleveland Medical Centerlead
Study Sites (7)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
Duke University
Durham, North Carolina, 27707, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pittsburgh, UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adonis Hijaz, MD
University Hospitals Cleveland Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be masked to the surgical randomization prior to surgery and will be informed of their surgical assignment (unmasked) after waking up from surgery and prior to discharge.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology
Study Record Dates
First Submitted
August 4, 2021
First Posted
October 1, 2021
Study Start
December 15, 2021
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
May 15, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Beginning 9 months and ending 36 months following publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal may use the data for any purpose.
All of the individual participant data collected during the trial will be made available after de-identification.