N/A
N=106
Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
Vaginal Vault Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT03681223 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants With Pelvic Organ Prolapse Recurrence — 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vertessa® Lite Y mesh (Device); Restorelle® Y mesh (Device); Laparoscopic sacrocolpopexy (Procedure); Robotic assisted laparoscopic sacrocolpopexy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pelvic Organ Prolapse Recurrence |
2; 1 | — |
| SECONDARY Number of Participants With Postoperative Complications |
0; 2 | — |
| SECONDARY Number of Participants With Mesh Exposure |
0; 0 | — |
| SECONDARY Number of Participants With Stress Incontinence Retreatment |
2; 2 | — |
| SECONDARY Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure |
-2.7; -1.3 | — |
| SECONDARY Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure |
-2.7; -1.3 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18, who are to undergo laparoscopic or robotic laparoscopic sacrocolpopexy for pelvic organ prolapse
- Other concomitant laparoscopic or prolapse and anti-incontinence procedures (e.g., laparoscopic supracervical hysterectomy, cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.
Exclusion Criteria
- Inability to comprehend written and/or spoken English
- Inability to provide informed consent
- Medical illness precluding laparoscopy
- Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
- Sacrocolpoperineopexy
- Need for dual flat mesh for sacrocolpopexy procedure (determined by surgeon)
Data sourced from ClinicalTrials.gov (NCT03681223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.