At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
In Brief
A clinical study evaluating Uterosacral ligament suspension and Uphold® LITE for Uterovaginal Prolapse. Completed, enrolled 183 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
The USLS procedure used in this protocol is a modification of the technique described by Shull.
The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.