Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse (PREMIER)

University Hospitals (UH)

Status: Enrolling

Conditions: Uterine Prolapse

Treatments: Procedure: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP); Procedure: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05063331

20210871

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Sacrocolpopexy

Active Comparator group

Description:

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

Treatment:

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

Uterosacral Ligament Suspension

Active Comparator group

Description:

Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Treatment:

Procedure: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)