Surgical Procedures for Uterovaginal Prolapse

(SUPeR Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NICHD Pelvic Floor Disorders Network

Disqualifiers: Chronic pelvic pain, Pelvic radiation, Uterine abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

183 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years. A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.

Research Team

Kate Meriwether, MD

Principal Investigator

University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology

Charles W Nager, MD

Principal Investigator

University of California at San Diego, UCSD Women's Pelvic Medicine Center

Anthony G Visco, MD

Principal Investigator

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Charles R Rardin, MD

Principal Investigator

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

Sonia Thomas, DrPH

Principal Investigator

RTI International

Holly E Richter, PhD, MD

Principal Investigator

University of Alabama at Birmingham, Department of Obstetrics and Gynecology

Marie Paraiso, MD

Principal Investigator

Cleveland Clinic, Department OB/GYN

Heidi Harvie, MD

Principal Investigator

University of Pennsylvania

Halina M Zyczynski, MD

Principal Investigator

Magee-Women's Hospital, Department of Obstetrics and Gynecology

Eligibility Criteria

This trial is for women over 21 who've finished having children, are not pregnant, and can follow up for up to 5 years. They should have uterovaginal prolapse beyond the hymen with bothersome symptoms but no history of certain pelvic treatments or conditions that would exclude them from safe participation.

Inclusion Criteria

Available for up to 60 month follow-up

My pelvic organ prolapse extends beyond the vaginal opening.

Amenorrhea for the past 12 months from either menopause or endometrial ablation

Exclusion Criteria

I have received radiation therapy to my pelvis.

My cervix is expected to be low in position after a specific pelvic surgery.

I am at high risk for cervical issues and need screenings more often due to factors like HIV, immune suppression, DES exposure, or past treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either vaginal hysterectomy with uterosacral ligament suspension or mesh hysteropexy suspension for uterovaginal prolapse

Surgical procedure

1 visit (in-person, surgical)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with follow-up data collected during in-person clinic visits

36-60 months

Multiple visits (in-person)

Treatment Details

Interventions

• Uphold® LITE
• Uterosacral ligament suspension

Trial Overview The study compares two surgical methods for fixing uterine prolapse: a mesh-augmented hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension. It aims to see which method is more effective over three years.

Participant Groups

Group I: Hysterectomy and USLS Active Control 1 Intervention

Vaginal hysterectomy and uterosacral ligament suspension (USLS)

Group II: Hysteropexy Active Control 1 Intervention

Uphold® LITE

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network

Lead Sponsor

Trials

16

Recruited

4,900+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology