Which mesh works best for prolapse? new study compares two options
NCT ID NCT03681223
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared two different surgical meshes used to repair vaginal vault prolapse, a condition where the top of the vagina drops down. About 100 women having laparoscopic or robotic surgery received either Restorelle® Y mesh or Vertessa® Lite Y mesh. The goal was to see if the newer mesh works just as well as the standard one in preventing prolapse from coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgical mesh (Restorelle® Y mesh or Vertessa® Lite Y mesh)
- What this could lead to
- If successful, this could show that Vertessa® Lite Y mesh is a safe and effective alternative to Restorelle® Y mesh for prolapse repair, giving surgeons more options.
- What could go wrong
- This is a small, completed trial with 106 participants, so results may not apply to everyone. Both meshes are already used in practice, so this is a comparison, not a breakthrough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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106 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Other studies related to the condition(s) this trial covers.