CystocelePRO-CURE IINCT02255994
UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
A study testing UGYTEX and No mesh. in people with Cystocele, run by Centre Hospitalier Universitaire de Nīmes at 12 sites in France.
Trial summary
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Cystocele
- What is being tested?
- UGYTEX and No mesh.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesFrance
- Study dates
- Oct 2014to 7 Dec 2015
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient included in, randomized and analysed in the PROCURE study (NCT00153257)
Who cannot join
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- Patient not included in the PROCURE study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Clinique Champeau
Béziers, 34500
APHP - Hôpital Antoine Beclere
Clamart, 92141
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, 63003
APHP - Hôpital Beaujon
Clichy, 92110
CH d'Issoire - Centre Hospitalier Paul Ardier
Issoire, 63503
CH de la Rochelle
La Rochelle, 17019
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, 28630
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, 94275
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CH d'Orange - Hôpital Louis Giorgi
Orange, 84106
Clinique Mutualiste La Sagesse
Rennes, 35000
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
About this study
Official title: Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.
Read the detailed description
Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):
- The anatomic failure rate of cystocele (POP-Q stage > or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs
- Conditions
- Cystocele
- Being tested
- UGYTEX, No mesh.
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UGYTEXDevice
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
No mesh.Procedure or surgery
Patients in this arm had subvesical plication without reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| UGYTEX | Experimental | Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257) Receives: Device: UGYTEX |
| No MESH | Active comparator | Patients in this arm had subvesical plication without reinforcement. Receives: Procedure: No mesh. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional failure
The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.
Measured: 5 years
Secondary outcomes (6)
Anatomical failure
The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years.
Measured: 5-8 years
Post-operative complications
Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh.
Measured: 5-8 years
The PGI-I questionnaire
Measured: 5-8 years
The PFDI questionnaire
Measured: 5-8 years
The PFIQ questionnaire
Measured: 5-8 years
The PISQ-12 questionnaire
Measured: 5-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion7 Dec 2015
- Study completion7 Dec 2015
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 CystoceleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud de Tayrac, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255994
- Sponsor's protocol ID
- LOCAL/2013/RdeT-01
- Other IDs
- 2013-A01705-40
- Acronym
- PRO-CURE II
- Status last verified
- Feb 2016
- First submitted
- 1 Oct 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Allegre L, Callewaert G, Alonso S, Cornille A, Fernandez H, Eglin G, de Tayrac R. Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse. Int Urogynecol J. 2020 Apr;31(4):745-753. doi: 10.1007/s00192-019-04073-x. Epub 2019 Sep 10.
PubMed 31506808
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse
- ClinicalTrials.gov ID
- NCT02255994
- Acronym / sponsor ID
- PRO-CURE II / LOCAL/2013/RdeT-01
- Conditions
- Cystocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 7 Dec 2015 (actual)
- First posted
- 3 Oct 2014 (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.
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.
Detailed description
Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):
- The anatomic failure rate of cystocele (POP-Q stage > or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UGYTEX | Experimental | Device: UGYTEXPatients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257) |
| No MESH | Active comparator | Procedure: No mesh.Patients in this arm had subvesical plication without reinforcement. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient included in, randomized and analysed in the PROCURE study (NCT00153257)
Key exclusion criteria (4 listed)
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- Patient not included in the PROCURE study
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 |
|---|---|---|
| UGYTEXPatients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257) | Device | UGYTEX |
| No mesh.Patients in this arm had subvesical plication without reinforcement. | Procedure or surgery | No MESH |
Primary outcome
Functional failure
Time frame: 5 years
The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.
6 secondary outcomes
Anatomical failure
Time frame: 5-8 years
Post-operative complications
Time frame: 5-8 years
The PGI-I questionnaire
Time frame: 5-8 years
The PFDI questionnaire
Time frame: 5-8 years
The PFIQ questionnaire
Time frame: 5-8 years
The PISQ-12 questionnaire
Time frame: 5-8 years
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 Nov 2025.
- Results publication: PubMed 31506808Allegre L, Callewaert G, Alonso S, Cornille A, Fernandez H, Eglin G, de Tayrac R. Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse. Int Urogynecol J. 2020 Apr;31(4):745-753. doi: 10.1007/s00192-019-04073-x. Epub 2019 Sep 10.
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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.
Renaud de Tayrac, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UGYTEX and No mesh. in people with Cystocele, run by Centre Hospitalier Universitaire de Nīmes at 12 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 4 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Functional failure (time frame: 5 years). 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 NCT02255994, 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 Nov 2025.