Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02255994
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052858', 'term': 'Cystocele'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2014-10-01', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional failure', 'timeFrame': '5 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Anatomical failure', 'timeFrame': '5-8 years', 'description': '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.'}, {'measure': 'Post-operative complications', 'timeFrame': '5-8 years', 'description': '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.'}, {'measure': 'The PGI-I questionnaire', 'timeFrame': '5-8 years'}, {'measure': 'The PFDI questionnaire', 'timeFrame': '5-8 years'}, {'measure': 'The PFIQ questionnaire', 'timeFrame': '5-8 years'}, {'measure': 'The PISQ-12 questionnaire', 'timeFrame': '5-8 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystocele']}, 'referencesModule': {'references': [{'pmid': '31506808', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):\n\nA. 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* Patient included in, randomized and analysed in the PROCURE study (NCT00153257)\n\nExclusion Criteria:\n\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* Patient not included in the PROCURE study'}, 'identificationModule': {'nctId': 'NCT02255994', 'acronym': 'PRO-CURE II', 'briefTitle': 'UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LOCAL/2013/RdeT-01'}, 'secondaryIdInfos': [{'id': '2013-A01705-40', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UGYTEX', 'description': 'Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)', 'interventionNames': ['Device: UGYTEX']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No MESH', 'description': 'Patients in this arm had subvesical plication without reinforcement.', 'interventionNames': ['Procedure: No mesh.']}], 'interventions': [{'name': 'UGYTEX', 'type': 'DEVICE', 'description': 'Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)', 'armGroupLabels': ['UGYTEX']}, {'name': 'No mesh.', 'type': 'PROCEDURE', 'description': 'Patients in this arm had subvesical plication without reinforcement.', 'armGroupLabels': ['No MESH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Béziers', 'country': 'France', 'facility': 'Clinique Champeau', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'APHP - Hôpital Antoine Beclere', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont Ferrand - Hôpital Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'APHP - Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '63503', 'city': 'Issoire', 'country': 'France', 'facility': "CH d'Issoire - Centre Hospitalier Paul Ardier", 'geoPoint': {'lat': 45.54422, 'lon': 3.24901}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'CH de la Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '28630', 'city': 'Le Coudray', 'country': 'France', 'facility': 'CH de Chartres - Hôpital Louis Pasteur', 'geoPoint': {'lat': 48.42115, 'lon': 1.50057}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'APHP - Centre Hospitalier Universitaire de Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '84106', 'city': 'Orange', 'country': 'France', 'facility': "CH d'Orange - Hôpital Louis Giorgi", 'geoPoint': {'lat': 44.13806, 'lon': 4.81025}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Clinique Mutualiste La Sagesse', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen - Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Renaud de Tayrac, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}