Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT00521066
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2007-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2007-08-24', 'studyFirstSubmitQcDate': '2007-08-24', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success based on overall POP-Q score at 12 months post-procedure.', 'timeFrame': '12-months', 'description': 'Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.'}], 'secondaryOutcomes': [{'measure': 'Success based on overall POP-Q score at 24 months post-procedure.', 'timeFrame': '24 months', 'description': 'Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP'}, {'measure': 'Success based on treated compartment ICS POP-Q stage', 'timeFrame': '12 months', 'description': 'Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.'}, {'measure': 'Success based on treated compartment ICS POP-Q stage', 'timeFrame': '24 months', 'description': 'Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.'}, {'measure': 'Success defined as the leading edge within the hymen', 'timeFrame': '12 months', 'description': 'Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)'}, {'measure': 'Success defined as the leading edge within the hymen', 'timeFrame': '24 months', 'description': 'Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)'}, {'measure': 'Mean PFDI-20 score', 'timeFrame': '12 months'}, {'measure': 'Mean PFDI-20 score', 'timeFrame': '24 months'}, {'measure': 'Mean change from baseline in PFDI-20 scores', 'timeFrame': '24 months'}, {'measure': 'Mean change from baseline in PFDI-20 scores', 'timeFrame': '12 months'}, {'measure': 'Mean POPDI score', 'timeFrame': '12 months', 'description': 'POPDI is a sub score of PFDI-20'}, {'measure': 'Mean POPDI score', 'timeFrame': '24 months', 'description': 'POPDI is a sub score of PFDI-20'}, {'measure': 'Mean change from baseline in POPDI score', 'timeFrame': '12 months', 'description': 'POPDI is a sub scores of PFDI-20'}, {'measure': 'Mean change from baseline in POPDI score', 'timeFrame': '24 months', 'description': 'POPDI is a sub score of PFDI-20'}, {'measure': 'Mean CRADI score', 'timeFrame': '12 months', 'description': 'CRADI is a sub score of PFDI-20'}, {'measure': 'Mean CRADI score', 'timeFrame': '24 months', 'description': 'CRADI is a sub score of PFDI-20'}, {'measure': 'Mean change from baseline in CRADI score', 'timeFrame': '12 months', 'description': 'CRADI is a sub score of PFDI-20'}, {'measure': 'Mean change from baseline in CRADI score', 'timeFrame': '24 months', 'description': 'CRADI is a sub score of PFDI-20'}, {'measure': 'Mean UDI score', 'timeFrame': '12 months', 'description': 'UDI is a sub score of PFDI-20'}, {'measure': 'Mean UDI score', 'timeFrame': '24 months', 'description': 'UDI is a sub score of PFDI-20'}, {'measure': 'Mean change from baseline in UDI score', 'timeFrame': '12 months', 'description': 'UDI is a sub score of PFDI-20'}, {'measure': 'Mean change from baseline in UDI score', 'timeFrame': '24 months', 'description': 'UDI is a sub score of PFDI-20'}, {'measure': 'EuroQol (EQ-5D health state) change from baseline', 'timeFrame': '12 months'}, {'measure': 'EuroQol (EQ-5D health state) change from baseline', 'timeFrame': '24 months'}, {'measure': 'Mean PFIQ-7 score', 'timeFrame': '12 months'}, {'measure': 'Mean PFIQ-7 score', 'timeFrame': '24 months'}, {'measure': 'Mean change from baseline in PFIQ-7 score', 'timeFrame': '12 months'}, {'measure': 'Mean change from baseline in PFIQ-7 score', 'timeFrame': '24 months'}, {'measure': 'Mean POPIQ score', 'timeFrame': '12 months', 'description': 'POPIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean POPIQ score', 'timeFrame': '24 months', 'description': 'POPIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean change from baseline in POPIQ score', 'timeFrame': '12 months', 'description': 'POPIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean change from baseline in POPIQ score', 'timeFrame': '24 months', 'description': 'POPIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean CRAIQ score', 'timeFrame': '12 months', 'description': 'CRAIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean CRAIQ score', 'timeFrame': '24 months', 'description': 'CRAIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean change from baseline in CRAIQ score', 'timeFrame': '12 months', 'description': 'CRAIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean change from baseline in CRAIQ score', 'timeFrame': '24 months', 'description': 'CRAIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean UIQ score', 'timeFrame': '12 months', 'description': 'UIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean UIQ score', 'timeFrame': '24 months', 'description': 'UIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean change from baseline in UIQ score', 'timeFrame': '12 months', 'description': 'UIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean change from baseline in UIQ score', 'timeFrame': '24 months', 'description': 'UIQ is a sub-score of PFIQ-7'}, {'measure': 'Mean PISQ-12 score', 'timeFrame': '12 months', 'description': 'In subjects sexually active at baseline, assessment of sexual function'}, {'measure': 'Mean PISQ-12 score', 'timeFrame': '24 months', 'description': 'In subjects sexually active at baseline, assessment of sexual function'}, {'measure': 'Mean change from baseline in PISQ-12 score', 'timeFrame': '12 months', 'description': 'In subjects sexually active at baseline, assessment of sexual function'}, {'measure': 'Mean change from baseline in PISQ-12 score', 'timeFrame': '24 months', 'description': 'In subjects sexually active at baseline, assessment of sexual function'}, {'measure': 'Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia', 'timeFrame': 'ongoing'}, {'measure': 'Length of procedure', 'timeFrame': 'perioperative', 'description': 'From time to first incision to time of last suture used to secure VSD'}, {'measure': 'Pain score measured using Visual Analog Scale (VAS).', 'timeFrame': '24 hours post surgery and at the 3-4 week visit'}, {'measure': 'Discomfort of balloon removal, measured using VAS at time of removal.', 'timeFrame': '24 hrs post-surgical'}, {'measure': 'Subject perception of VSD: Awareness', 'timeFrame': '3-4 week visit', 'description': 'Measured by visual analogue scale'}, {'measure': 'Subject perception of VSD: Discomfort', 'timeFrame': '3-4 week visit', 'description': 'Measured by visual analogue scale'}, {'measure': 'Subject perception of VSD: Acceptability of discharge', 'timeFrame': '3-4 week visit', 'description': 'Measured by visual analogue scale'}, {'measure': 'Subject global impression', 'timeFrame': '12 month visit', 'description': 'assessed on a 5 point Likert scale'}, {'measure': 'Subject global impression', 'timeFrame': '24 month visit', 'description': 'assessed on a 5 point Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '20934681', 'type': 'RESULT', 'citation': 'Zyczynski HM, Carey MP, Smith AR, Gauld JM, Robinson D, Sikirica V, Reisenauer C, Slack M; Prosima Study Investigators. One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device. Am J Obstet Gynecol. 2010 Dec;203(6):587.e1-8. doi: 10.1016/j.ajog.2010.08.001.'}, {'pmid': '22143448', 'type': 'RESULT', 'citation': 'Sayer T, Lim J, Gauld JM, Hinoul P, Jones P, Franco N, Van Drie D, Slack M; Prosima Study Investigators. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device. Int Urogynecol J. 2012 Apr;23(4):487-93. doi: 10.1007/s00192-011-1600-3. Epub 2011 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.\n\n(\\*TRADEMARK)', 'detailedDescription': 'The GYNECARE PROSIMA\\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.\n* Age ≥ 18 years.\n* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.\n\nExclusion Criteria:\n\n* Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).\n* Previous repair of pelvic organ prolapse involving insertion of mesh.\n* Previous hysterectomy within 6 months of scheduled surgery.\n* Experimental drug or experimental medical device within 3 months prior to the planned procedure.\n* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.\n* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.\n* History of chemotherapy or pelvic radiation therapy.\n* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).\n* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).\n* Nursing or pregnant or intends future pregnancy.\n* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol."}, 'identificationModule': {'nctId': 'NCT00521066', 'briefTitle': 'GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse', 'orgStudyIdInfo': {'id': '300-06-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Prosima Pelvic Floor Repair System', 'interventionNames': ['Device: GYNECARE PROSIMA* Pelvic Floor Repair System']}], 'interventions': [{'name': 'GYNECARE PROSIMA* Pelvic Floor Repair System', 'type': 'DEVICE', 'otherNames': ['mesh pelvic floor repari'], 'description': 'procedure for pelvic organ prolapse', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Specialists in Urology', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Female Pelvic Medicine and Urogynecology Institute of Michigan', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '49506', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Female Pelvic Medicine & Urogynecology', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Institute for Female Pelvic Medicine & Reconstructive Surgery', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee Women's Hospital of the Universtiy of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '3053', 'city': 'Melbourne', 'country': 'Australia', 'facility': "Royal Women's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '06097', 'city': 'Halle', 'country': 'Germany', 'facility': 'Bereich Urogynakologie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitatsklinik Tubingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrookes Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'RG24 9NA', 'city': 'Hampshire', 'country': 'United Kingdom', 'facility': 'North Hampshire Hospital'}, {'zip': 'M13 0JH', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'David Robinson, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}