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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Uterine Prolapse
• Intervention / Treatment: Procedure: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP); Procedure: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Detailed Description

This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, UPMC Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women ≥ 18 years of age and ≤ 80 years of age
2. Have diagnosis of symptomatic uterovaginal prolapse
3. Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
4. Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Exclusion Criteria:

1. Patients who wish to undergo uterine sparing procedures
2. Body mass index BMI) > 50
3. Previous hysterectomy or prior uterovaginal surgery
4. Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
5. Chronic indwelling urinary catheter
6. Urinary diversion of any type
7. 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
8. Unable to speak, read, understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sacrocolpopexy; Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)	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.
Active Comparator: Uterosacral Ligament Suspension; Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain medication use	Postoperative pain medication use will be assessed using the total morphine equivalent dosing (MED) for narcotics and using the total dosage for non-narcotics.	Post-surgery through Day 14
Change in surgical pain using VAS	Longitudinal pain score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome.	Baseline, Days 1, 7 and 14 post-surgery
Postoperative anti-emetic use	Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.	Post-surgery through Day 14
Change in nausea using VAS	Longitudinal nausea score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome.	Baseline, Days 1, 7 and 14 post-surgery
Change in fatigue using MAF	Fatigue will be assessed utilizing the Multi-Dimensional Assessment of Fatigue (MAF) Scale with a score of 1 to 148 where a higher score means a worse outcome.	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
Change in bladder function using UDI-6	Bladder function will be assessed using the Urinary Distress Inventory-6 (UDI-6) which is questions 15-20 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 18 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in bladder function using IIQ-7	Bladder function will be assessed using the Incontinence Impact Questionnaire-7 (IIQ-7) with a score of 0 to 21 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in bowel function using CRAD-8	Bowel function will be assessed using the Colorectal Anal Distress Inventory 8 (CRAD-8) which is questions 7-14 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 24 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in sexual function using PISQ-12	Sexual function will be assessed using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with a score of 0 to 48 where a higher score means a worse outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Change in sexual function using FSFI	Sexual function will be assessed using the Female Sexual Function Inventory (FSFI) with a score of 2 to 36 where higher score where a higher score means a better outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Change in body image using BIPOP	Body image will be assessed using the Body Image in Pelvic Organ Prolapse Questionnaire (BIPOP) with a score of 1 to 5 where a higher score means a better outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Change in quality of life using P-QOL	General quality of life will be assessed using the Pelvic Organ Prolapse Quality of Life Questionnaire (P-QOL) with a score in each domain of 0 to 100 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in satisfaction with care using PGI-I	Satisfaction with care will be assessed using the Patient Global Impression of Improvement (PGI-I) scale with a score of 1 to 7 where higher score means a worse outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Rate of Grade I-V DINDO complications in each surgical arm	Surgical complications will be assessed using the Clavien-Dindo standardized classification system with a grade of I to V where the higher grade means a worse outcome.	Surgery through 36 months post-surgery

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Mayo Clinic; University of Pittsburgh; The Cleveland Clinic; Duke University; Case Western Reserve University; MetroHealth Medical Center; Northwestern Medicine
• Investigators: Principal Investigator: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Sacrocolpopexy; Uterosacral Ligament Suspension
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Signs and Symptoms; Uterine Prolapse; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Hysterectomy; Hysterectomy, Vaginal
• Other Study ID Numbers: 20210871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial will be made available after de-identification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal may use the data for any purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No