Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design

NAActive, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

July 28, 2022

Study Completion Date

December 31, 2026

Conditions
Visceral Prolapse
Interventions
PROCEDURE

Open, Robotic, or Laparoscopic

Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.

PROCEDURE

Transvaginal Native Tissue Repair

Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).

PROCEDURE

Uphold™ LITE

Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina.

Trial Locations (10)

15213

University of Pittsburgh, Pittsburgh

19118

University of Pennsylvania, Philadelphia

27707

Duke University, Durham

35233

University of Alabama at Birmingham, Birmingham

44195

Cleveland Clinic, Cleveland

75390

University of Texas Southwestern Medical Center, Dallas

87131

University of New Mexico, Albuquerque

92037

University of California at San Diego, San Diego

92110

Kaiser Permanente, San Diego

02903

Brown/Women and Infants Hospital of Rhode Island, Providence

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

Duke University

OTHER

collaborator

University of New Mexico

OTHER

collaborator

Women and Infants Hospital of Rhode Island

OTHER

collaborator

RTI International

OTHER

collaborator

University of Pennsylvania

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

Kaiser Permanente

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

NICHD Pelvic Floor Disorders Network

NETWORK