NCT03681223: Lite-Y

Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

Completed NA Results posted Last updated 30 January 2026

What this trial tests

NA trial testing Vertessa® Lite Y mesh in Vaginal Vault Prolapse in 106 participants. Completed in 19 December 2023.

Timeline

18 September 2018

Primary endpoint
19 December 2023

19 December 2023

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	106
Start date	18 September 2018
Primary completion	19 December 2023
Estimated completion	19 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Vertessa® Lite Y mesh
• Restorelle® Y mesh
• Laparoscopic sacrocolpopexy
• Robotic assisted laparoscopic sacrocolpopexy

Conditions studied

• Vaginal Vault Prolapse — all drugs for Vaginal Vault Prolapse →

Sponsor

The Cleveland Clinic

Who can join

18 and older, female only, with Vaginal Vault Prolapse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Pelvic Organ Prolapse Recurrence Primary · 24 months

Retreatment for prolapse by either surgery or pessary

Group	Value	95% CI
Restorelle® Y Mesh	2
Vertessa® Lite Y Mesh	1

Number of Participants With Postoperative Complications Secondary · 6 months

Any postoperative complication at 6 months, including the following: Wound Infection Hematoma Pelvic Abscess VTE/PE Bowel Injury, Bowel Obstruction Port Site Hernia Lower Urinary Tract Injury Neurologic Injury

Group	Value	95% CI
Restorelle® Y Mesh	0
Vertessa® Lite Y Mesh	2

Number of Participants With Mesh Exposure Secondary · 24 months

Mesh exposure on physical exam up to 24 months following surgery

Group	Value	95% CI
Restorelle® Y Mesh	0
Vertessa® Lite Y Mesh	0

Number of Participants With Stress Incontinence Retreatment Secondary · 24 months

Stress incontinence retreatment including urethral bulking or sling up to 24 months following surgery

Group	Value	95% CI
Restorelle® Y Mesh	2
Vertessa® Lite Y Mesh	2

Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure Secondary · Baseline (pre-procedure) to 24-months (post-procedure)

The PFDI-20 (Pelvic Floor Distress Inventory - 20 items) measures pelvic floor dysfunction symptoms across three scales (POPDI-6, UDI-6, CRADI-8), with each item scored 0-4; to score, sum items per scale, find the mean, then multiply by 25 (0-100 range), and add scale scores for a total PFDI-20 score (0-300), where higher scores mean worse distress. A score of 0 indicates no symptoms. Mild - less than or equal to 100; Moderate - greater than 100 but less than or equal to 200; and Severe - greater than 200.

Group	Value	95% CI
Restorelle® Y Mesh	-78.8	± 49.8
Vertessa® Lite Y Mesh	-75.1	± 59.5

Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure Secondary · Baseline (pre-procedure) to 24-months (post-procedure)

The Incontinence Severity Index (ISI) is a validated measure that quantifies urinary incontinence severity based on patient-reported frequency and amount of leakage. Scores are calculated by multiplying the frequency score (0-4) by the amount score (1-3), yielding possible total scores of 0, 1, 2, 3, 4, 6, 8, 9, and 12. The minimum possible score is 0, indicating no incontinence, and the maximum possible score is 12, indicating very severe incontinence. ISI scores are categorized as follows: 0 (dry), 1-2 (slight), 3-6 (moderate), 8-9 (severe), and 12 (very severe). Lower scores reflect less se

Group	Value	95% CI
Restorelle® Y Mesh	-2.7	± 6.1
Vertessa® Lite Y Mesh	-1.3	± 6.3

Sponsor's own description

This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse.

Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.