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

NCT03681223 | Completed Results FDA Device

• 1 other identifier: 18-907
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vaginal Vault Prolapse

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pelvic Organ Prolapse Recurrence

  Retreatment for prolapse by either surgery or pessary

  24 months

Secondary Outcomes (5)

• Number of Participants With Postoperative Complications

  6 months

• Number of Participants With Mesh Exposure

  24 months

• Number of Participants With Stress Incontinence Retreatment

  24 months

• Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure

  Baseline (pre-procedure) to 24-months (post-procedure)

• Mean Difference Between Baseline (Pre-procedure) and 24-months Post-procedure

  Baseline (pre-procedure) to 24-months (post-procedure)

Study Arms (2)

Restorelle® Y mesh

ACTIVE COMPARATOR

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

Device: Restorelle® Y mesh; Procedure: Laparoscopic sacrocolpopexy; Procedure: Robotic assisted laparoscopic sacrocolpopexy

Vertessa® Lite Y mesh

EXPERIMENTAL

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

Device: Vertessa® Lite Y mesh; Procedure: Laparoscopic sacrocolpopexy; Procedure: Robotic assisted laparoscopic sacrocolpopexy

Interventions

Restorelle® Y mesh DEVICE

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.

Restorelle® Y mesh

Laparoscopic sacrocolpopexy PROCEDURE

The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation

Restorelle® Y mesh; Vertessa® Lite Y mesh

Vertessa® Lite Y mesh DEVICE

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.

Vertessa® Lite Y mesh

Robotic assisted laparoscopic sacrocolpopexy PROCEDURE

The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation

Restorelle® Y mesh; Vertessa® Lite Y mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (7)

• Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4.

  PMID: 19201521 BACKGROUND

• Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet Gynecol. 2013 Feb;121(2 Pt 1):354-374. doi: 10.1097/AOG.0b013e31827f415c.

  PMID: 23344287 BACKGROUND

• Porges RF, Smilen SW. Long-term analysis of the surgical management of pelvic support defects. Am J Obstet Gynecol. 1994 Dec;171(6):1518-26; discussion 1526-8. doi: 10.1016/0002-9378(94)90395-6.

  PMID: 7802061 BACKGROUND

• Birch C. The use of prosthetics in pelvic reconstructive surgery. Best Pract Res Clin Obstet Gynaecol. 2005 Dec;19(6):979-91. doi: 10.1016/j.bpobgyn.2005.08.013. Epub 2005 Sep 26.

  PMID: 16185932 BACKGROUND

• Chu CC, Welch L. Characterization of morphologic and mechanical properties of surgical mesh fabrics. J Biomed Mater Res. 1985 Oct;19(8):903-16. doi: 10.1002/jbm.820190803.

  PMID: 3880350 BACKGROUND

• Kaupp HA, Matulewicz TJ, Lattimer GL, Kremen JE, Celani VJ. Graft infection or graft reaction? Arch Surg. 1979 Dec;114(12):1419-22. doi: 10.1001/archsurg.1979.01370360073009.

  PMID: 160778 BACKGROUND

• Salamon CG, Lewis C, Priestley J, Gurshumov E, Culligan PJ. Prospective study of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy. Int Urogynecol J. 2013 Aug;24(8):1371-5. doi: 10.1007/s00192-012-2021-7. Epub 2013 Jan 8.

  PMID: 23296684 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cecile Ferrando, M.D.
• Organization: Cleveland Clinic

cferrando@ucsd.edu

216-645-0081

Study Officials

• Cecile A Unger, MD, MPH

  Assistant Professor of Surgery. Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland OH

  PRINCIPAL INVESTIGATOR

• Marie Fidela R Paraiso, MD

  Professor, Section Head of the Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All patients will be blinded to their assignment, investigators will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 either Restorelle® or Vertessa® Y sacrocolpopexy according to a computer-generated randomization.

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: September 18, 2018
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)