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Glue instead of stitches: new fix for prolapse surgery?

NCT ID NCT02011373

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a synthetic glue called IFABOND to attach surgical mesh during laparoscopic sacrocolpopexy, a surgery for pelvic organ prolapse. The goal was to see if using glue instead of staples or stitches reduces complications like vaginal erosion. 70 women with advanced prolapse took part, and the main measure was how well the prolapse correction held up after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IFABOND synthetic glue
What this could lead to
If successful, this glue could offer a safer way to attach surgical mesh during prolapse repair, reducing complications like vaginal erosion.
What could go wrong
This is a small, non-randomized study with only 70 participants. The glue may not work as well as standard methods, and long-term safety is not yet known.

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

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

70 people

The number who actually took part.

Started

Nov 2013

Finished

Oct 2018

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Woman aged 18 years or more * Stage III or IV medial and/or anterior genital prolapse on the Pelvic Organ Prolapse Quantification (POP-Q) classification (hysterocele and/or cystocele), requiring surgical correction * Patient requesting surgery for the trouble caused by the prolapse Exclusion Criteria: * Prolapse of POP-Q stage \<III or without functional impact * Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc. * Impaired lower-limb range of motion preventing positioning for surgery * Pregnancy or intended pregnancy during study period * Evolutive or latent infection or signs of tissue necrosis on clinical examination * Non-controlled diabetes (glycated haemoglobin \>8%) * Treatment impacting immune response (immunomodulators), ongoing or within previous month * History of pelvic region radiation therapy, at any time * History of pelvic cancer * Non-controlled evolutive spinal pathology * Known hypersensitivity to one of the implant components (polypropylene) * Cyanoacrylate hypersensitivity * Formaldehyde hypersensitivity * Inability to understand information provided * No national health insurance cover; prisoner, or ward of court

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse Prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Medial and/or anterior genital prolapse

Contacts and locations

Locations

  • Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

    Pierre-Bénite, 69495, France

  • Gynaecology Department, Hôpital Femme Mère Enfant

    Bron, 69677, France

  • Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

    Lyon, 69004, France