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NCT Number: NCT05063331

Patient-Centered Outcomes in the Surgical 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Uterine Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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

Procedure

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.

Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Procedure

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

Primary outcomes

  1. Treatment failure

    Time frame: 36 months post-surgery

    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.

Secondary outcomes

  1. Postoperative pain medication use

    Time frame: Post-surgery through Day 14

    Postoperative pain medication use will be assessed using the total morphine equivalent dosing (MED) for narcotics and using the total dosage for non-narcotics.

  2. Change in surgical pain using VAS

    Time frame: Baseline, Days 1, 7 and 14 post-surgery

    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.

  3. Postoperative anti-emetic use

    Time frame: Post-surgery through Day 14

    Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.

  4. Change in nausea using VAS

    Time frame: Baseline, Days 1, 7 and 14 post-surgery

    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.

  5. Change in fatigue using MAF

    Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery

    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.

  6. Change in bladder function using UDI-6

    Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery

    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.

  7. Change in bladder function using IIQ-7

    Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery

    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.

  8. Change in bowel function using CRAD-8

    Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery

    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.

  9. Change in sexual function using PISQ-12

    Time frame: Baseline, 6, 12, 24, and 36 months post-surgery

    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.

  10. Change in sexual function using FSFI

    Time frame: Baseline, 6, 12, 24, and 36 months post-surgery

    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.

  11. Change in body image using BIPOP

    Time frame: Baseline, 6, 12, 24, and 36 months post-surgery

    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.

  12. Change in quality of life using P-QOL

    Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery

    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.

  13. Change in satisfaction with care using PGI-I

    Time frame: Baseline, 6, 12, 24, and 36 months post-surgery

    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.

  14. Rate of Grade I-V DINDO complications in each surgical arm

    Time frame: Surgery through 36 months post-surgery

    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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Case Western Reserve University
  • Duke University
  • Mayo Clinic
  • MetroHealth Medical Center
  • Northwestern Medicine
  • The Cleveland Clinic
  • University of Pittsburgh

Registry information

Official study title

Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

Acronym: PREMIER

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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