UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
NCT ID: NCT02255994
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2014-10-31
2015-12-07
Brief Summary
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Detailed Description
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A. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UGYTEX
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
UGYTEX
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
No MESH
Patients in this arm had subvesical plication without reinforcement.
No mesh.
Patients in this arm had subvesical plication without reinforcement.
Interventions
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UGYTEX
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
No mesh.
Patients in this arm had subvesical plication without reinforcement.
Eligibility Criteria
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Inclusion Criteria
* The patient must be insured or beneficiary of a health insurance plan
* Patient included in, randomized and analysed in the PROCURE study (NCT00153257)
Exclusion Criteria
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient not included in the PROCURE study
60 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Renaud de Tayrac, MD, PhD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nîmes
Locations
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Clinique Champeau
Béziers, , France
APHP - Hôpital Antoine Beclere
Clamart, , France
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, , France
APHP - Hôpital Beaujon
Clichy, , France
CH d'Issoire - Centre Hospitalier Paul Ardier
Issoire, , France
CH de la Rochelle
La Rochelle, , France
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, , France
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, , France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
CH d'Orange - Hôpital Louis Giorgi
Orange, , France
Clinique Mutualiste La Sagesse
Rennes, , France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, , France
Countries
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References
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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.
Other Identifiers
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2013-A01705-40
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2013/RdeT-01
Identifier Type: -
Identifier Source: org_study_id
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