Trial Outcomes & Findings for Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy (NCT NCT03681223)

Results Overview

Retreatment for prolapse by either surgery or pessary

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

24 months

Results posted on

2026-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Restorelle® Y Mesh All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Overall Study STARTED	54	52
Overall Study COMPLETED	47	44
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Restorelle® Y Mesh All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Overall Study Lost to Follow-up	7	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restorelle® Y Mesh n=54 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=52 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Total n=106 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 9 • n=35 Participants	58 years STANDARD_DEVIATION 10 • n=4328 Participants	60 years STANDARD_DEVIATION 9 • n=8687 Participants
Sex: Female, Male Female	54 Participants n=35 Participants	52 Participants n=4328 Participants	106 Participants n=8687 Participants
Sex: Female, Male Male	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) White	54 Participants n=35 Participants	52 Participants n=4328 Participants	106 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Region of Enrollment United States	54 Participants n=35 Participants	52 Participants n=4328 Participants	106 Participants n=8687 Participants

PRIMARY outcome

Timeframe: 24 months

Retreatment for prolapse by either surgery or pessary

Outcome measures

Outcome measures
Measure	Restorelle® Y Mesh n=47 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=44 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Number of Participants With Pelvic Organ Prolapse Recurrence	2 participants	1 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Restorelle® Y Mesh n=47 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=44 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Number of Participants With Postoperative Complications	0 participants	2 participants

SECONDARY outcome

Timeframe: 24 months

Mesh exposure on physical exam up to 24 months following surgery

Outcome measures

Outcome measures
Measure	Restorelle® Y Mesh n=47 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=44 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Number of Participants With Mesh Exposure	0 participants	0 participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure	Restorelle® Y Mesh n=47 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=44 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Number of Participants With Stress Incontinence Retreatment	2 participants	2 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Restorelle® Y Mesh n=47 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=44 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure	-78.8 units on a scale Standard Deviation 49.8	-75.1 units on a scale Standard Deviation 59.5

SECONDARY outcome

Timeframe: 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 severe symptoms and represent more favorable outcomes, whereas higher scores indicate greater symptom burden and worse clinical outcomes. Improvement in incontinence severity is defined as a decrease in ISI score over time, while worsening is defined as an increase in score.

Outcome measures

Outcome measures
Measure	Restorelle® Y Mesh n=47 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy Restorelle® Y mesh: Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation	Vertessa® Lite Y Mesh n=44 Participants All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy Vertessa® Lite Y mesh: Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive. Laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation Robotic assisted laparoscopic sacrocolpopexy: The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure	-2.7 units on a scale Standard Deviation 6.1	-1.3 units on a scale Standard Deviation 6.3

Adverse Events

Restorelle® Y Mesh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vertessa® Lite Y Mesh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cecile Ferrando, M.D.

Cleveland Clinic

Phone: 216-645-0081

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place