Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2026-06-06 @ 8:30 PM
Study NCT ID:
NCT02272361
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.
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': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFDI-20 score', 'timeFrame': '4 years', 'description': 'The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystocele']}, 'referencesModule': {'references': [{'pmid': '23618743', 'type': 'BACKGROUND', 'citation': 'Lucot JP, Fritel X, Debodinance P, Bader G, Cosson M, Giraudet G, Collinet P, Rubod C, Fernandez H, Fournet S, Lesavre M, Deffieux X, Faivre E, Trichot C, Demoulin G, Jacquetin B, Savary D, Botchorichvili R, Campagne Loiseau S, Salet-Lizee D, Villet R, Gadonneix P, Delporte P, Ferry P, Aucouturier JS, Thirouard Y, de Tayrac R, Fatton B, Wagner L, Nadeau C, Wattiez A, Garbin O, Youssef Azer Akladios C, Thoma V, Baulon Thaveau E, Saussine C, Hermieu JF, Delmas V, Blanc S, Tardif D, Fauconnier A; GROG (groupe de recherche en gynecologie et obstetrique). [PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. J Gynecol Obstet Biol Reprod (Paris). 2013 Jun;42(4):334-41. doi: 10.1016/j.jgyn.2013.03.012. Epub 2013 Apr 22. French.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.\n\nThe secondary objectives of this study are the following:\n\n1. to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.\n2. to overall quality of life assessment and expectations of patients.\n3. to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.\n4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:\n* Written informed consent\n* insured under the French social security system\n\nExclusion Criteria:\n\n* Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol\n* Participation in another trial"}, 'identificationModule': {'nctId': 'NCT02272361', 'acronym': 'PROSPERE4', 'briefTitle': 'Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up', 'orgStudyIdInfo': {'id': '2014_03'}, 'secondaryIdInfos': [{'id': '2014-A00258-39', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'laparoscopic sacrocolpopexy', 'description': 'laparoscopic sacrocolpopexy', 'interventionNames': ['Other: laparoscopic sacrocolpopexy']}, {'type': 'OTHER', 'label': 'vaginal mesh surgery', 'description': 'vaginal mesh surgery', 'interventionNames': ['Other: vaginal mesh surgery']}], 'interventions': [{'name': 'laparoscopic sacrocolpopexy', 'type': 'OTHER', 'armGroupLabels': ['laparoscopic sacrocolpopexy']}, {'name': 'vaginal mesh surgery', 'type': 'OTHER', 'armGroupLabels': ['vaginal mesh surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74374', 'city': 'Annecy', 'country': 'France', 'facility': 'Sébatien BLANC', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hôpital Antoine Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59760', 'city': 'Grande-Synthe', 'country': 'France', 'facility': 'GCS Flandre Maritime', 'geoPoint': {'lat': 51.0154, 'lon': 2.29975}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'CH La Rochelle Service de Gynécologie Obstétrique', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital BICETRE / Service de Gynécologie Obstétrique', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille - Service de Gynécologie médico chirurgicale', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Diaconesses Croix St-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '78303', 'city': 'Poissy', 'country': 'France', 'facility': 'CHI Poissy-St-Germain / Service de gynécologie', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Jean-Philippe LUCOT, MD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}