Study of Uterine Prolapse Procedures - Randomized Trial

Summary

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.

Conditions

• Uterovaginal Prolapse

Interventions

PROCEDURE

Uterosacral ligament suspension

The USLS procedure used in this protocol is a modification of the technique described by Shull.

PROCEDURE

Uphold® LITE

The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.

Sponsors & Collaborators

• Boston Scientific Corporation

  collaborator INDUSTRY

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• Charles W Nager, MD · University of California at San Diego, UCSD Women's Pelvic Medicine Center

• Anthony G Visco, MD · Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

• Heidi Harvie, MD · University of Pennsylvania

• Marie Paraiso, MD · Cleveland Clinic, Department OB/GYN

• Charles R Rardin, MD · Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

• Holly E Richter, PhD, MD · University of Alabama at Birmingham, Department of Obstetrics and Gynecology

• Kate Meriwether, MD · University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology

• Halina M Zyczynski, MD · Magee-Women's Hospital, Department of Obstetrics and Gynecology

• Sonia Thomas, DrPH · RTI International

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-01

Primary Completion

2023-07-31

Completion

2025-03-07

Countries

• United States

Study Locations