PREMIER TRIAL

STUDY BASICS

Are you woman 18 to 80 years of age? Have you been diagnosed with symptomatic uterovaginal prolapse? You may be eligible for a research study to determine which surgery has the lowest number of short-term and long-term medical problems. Compensation is provided.

STUDY PURPOSE

The purpose of this study is to compare the two most common corrective surgeries in the U.S. for uterovaginal prolapse (UVP). 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 determine which surgery works best from a patient’s perspective and has the lowest number of short-term and long-term medical problems.

COULD THIS STUDY BE RIGHT FOR YOU?

• Woman age 18 to 80 years old
• Diagnosed with symptomatic uterovaginal prolapse

WHAT PARTICIPANTS CAN EXPECT

• If you join the study, the study would assign you to have one of the two surgeries, instead of choosing the surgery yourself.
• We would collect your medical information from your clinical visits for UVP. This would include your pre-surgery visits, your surgery, and post-surgical follow up visits for 3 years. 
• We would ask you to complete 6 to 7 questionnaires at 6 of your clinical outpatient visits (before and after surgery).These may add about 15 minutes to the time of your doctor’s appointments.
• We would also ask you to complete some brief questionnaires following your surgery for 2 weeks.