PREMIER Trial (Uterovaginal Prolapse)

Purpose of this Study

We are doing this study is to compare the two most common corrective surgeries in the U.S. for uterovaginal prolapse (UVP). For now, no high-quality data exists to help guide patients and surgeons on the best option for treatment of UVP. The goal of the study is to find out which surgery works best from a patient's perspective and has the lowest number of short-term and long-term medical problems.

Who Can Participate?

Eligibility

Women ages 18-80 who:
  • Are diagnsoed with symptomatic uterovaginal prolapse
  • Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
  • Have a body mass index (BMI) that is less than 50
  • Do not have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular disease
For more information about who can join this study, please contact the study team at eliza.sorrell@duke.edu.

Age Range

18-80

Sex/Genders

Female (cisgender)
Looking for Healthy Participants
No

What is Involved?

Description

If you join choose to join this study, you will get a random assignment to have one of the following surgeries done:
  • Total vaginal hysterectomy with uterosacral ligament suspension (vaginal approach); OR
  • Minimally invasive supracervical hysterectomy with sacrocolpopexy using FDA-approved abdominal mesh (abdominal approach)
After your assigned surgery, we will collect the information from the medical visits (outpatient and inpatient) related to your care leading up to surgery and for 3 years following your surgery. You will be asked to complete questionnaires about your symptoms and how UVP affects your quality of life. The questionnaires are often used in usual patient care, but we are asking you to complete them specifically for research purposes.

Locations

Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Principal Investigator

John
Jelovsek

Protocol Number

PRO00108871

NCT ID

NCT05063331

Enrollment Status

Open to Enrollment
ClinicalTrials.gov