Medial and/or Anterior Genital ProlapsePRO-COLLENCT02011373
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
A study testing fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ in people with Medial and/or Anterior Genital Prolapse, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medial and/or Anterior Genital Prolapse
- What is being tested?
- fixation technique using a sterile synthetic liquid tissue glue: IFABOND™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Nov 2013to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Gynaecology Department, Hôpital Femme Mère Enfant
Bron, 69677
Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.
- Conditions
- Medial and/or Anterior Genital Prolapse
- Being tested
- fixation technique using a sterile synthetic liquid tissue glue: IFABOND™
- Keywords
- prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation technique using a sterile synthetic liquid tissue glue: IFABOND™Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| IFABOND | Experimental | Not described Receives: Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage prolapse correction failure
Measured: 12 months post-surgery
Secondary outcomes (4)
Percentage prolapse correction failure
Measured: 24 months post-surgery
Percentage immediate postoperative failure
Measured: 1 month post-surgery
Complications rate
Measured: Peroperative and 1, 12 and 24 months post-surgery
Quality of life score
Measured: 1, 12 and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start6 Nov 2013
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medial and/or Anterior Genital ProlapseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Vitalitec
- Responsible party
- Sponsor
- Investigators
- Gery Lamblin, MD, Principal investigator, Gynaecology Department, Hôpital Femme Mère Enfant, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011373
- Sponsor's protocol ID
- 2013.804
- Acronym
- PRO-COLLE
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamblin G, Chene G, Warembourg S, Jacquot F, Moret S, Golfier F. Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up. Int Urogynecol J. 2022 Sep;33(9):2533-2541. doi: 10.1007/s00192-021-04764-4. Epub 2021 Mar 20.
PubMed 33742249
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02011373
- Acronym / sponsor ID
- PRO-COLLE / 2013.804
- Conditions
- Medial and/or Anterior Genital Prolapse
- Keywords
- prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Vitalitec
- Study start
- 6 Nov 2013 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFABOND | Experimental | Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ | Procedure or surgery | IFABOND |
Primary outcome
Percentage prolapse correction failure
Time frame: 12 months post-surgery
4 secondary outcomes
Percentage prolapse correction failure
Time frame: 24 months post-surgery
Percentage immediate postoperative failure
Time frame: 1 month post-surgery
Complications rate
Time frame: Peroperative and 1, 12 and 24 months post-surgery
Quality of life score
Time frame: 1, 12 and 24 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 33742249Lamblin G, Chene G, Warembourg S, Jacquot F, Moret S, Golfier F. Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up. Int Urogynecol J. 2022 Sep;33(9):2533-2541. doi: 10.1007/s00192-021-04764-4. Epub 2021 Mar 20.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gery Lamblin, MD principal investigator
Gynaecology Department, Hôpital Femme Mère Enfant, Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ in people with Medial and/or Anterior Genital Prolapse, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage prolapse correction failure (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.