Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-04-21 @ 10:55 AM
Study NCT ID:
NCT02642835
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jraduckett@hotmail.com', 'phone': '01634', 'title': 'Professor Jonaathan Duckett -Consultant Urogynaecologist', 'phoneExt': '835154', 'organization': 'Medway NHS Foundation Trust'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.\n\nA stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Complaining of a Bulge. Recurrent Prolapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'Efficacy determined by the question in the pelvic floor prolapse distress inventory "usually have a bulge or something falling out that you can see or feel in your vaginal area". Determined at clinic visit by questioning', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed New Stress Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Rated Their Improvement as Better or Very Much Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Needed Surgical Mesh Removal for Erosion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Needed Reoperations for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Intraoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'This records any problems that were encountered at the original insertion of the mesh. clinic visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mesh Group', 'description': 'all had an anterior mesh for recurrent prolapse'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mesh Group', 'description': 'underwent anterior mesh for recurrent cystocele'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'wt kg/ht m squared', 'dispersionType': 'FULL_RANGE'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'vaginal deliveries past 28 weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'time to follow up (months)', 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '106'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of months', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-17', 'studyFirstSubmitDate': '2015-08-27', 'resultsFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2015-12-27', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-17', 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted', 'timeFrame': '1 hour', 'description': 'clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination', 'timeFrame': '1 hour', 'description': 'The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.\n\nA stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina.'}, {'measure': 'Number of Participants Complaining of a Bulge. Recurrent Prolapse', 'timeFrame': '1 hour', 'description': 'Efficacy determined by the question in the pelvic floor prolapse distress inventory "usually have a bulge or something falling out that you can see or feel in your vaginal area". Determined at clinic visit by questioning'}, {'measure': 'Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina', 'timeFrame': '1 hour', 'description': 'clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment'}, {'measure': 'Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment', 'timeFrame': '1 hour', 'description': 'This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.'}, {'measure': 'Number of Participants Who Developed New Stress Incontinence', 'timeFrame': '1 hour', 'description': 'The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit'}, {'measure': 'Number of Participants Who Rated Their Improvement as Better or Very Much Better', 'timeFrame': '1 hour', 'description': 'The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit'}, {'measure': 'Number of Participants Who Needed Surgical Mesh Removal for Erosion', 'timeFrame': '1 hour', 'description': 'A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit'}, {'measure': 'Number of Participants Who Needed Reoperations for Pain', 'timeFrame': '1 hour', 'description': 'patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit'}, {'measure': 'Number of Participants Who Experienced Intraoperative Complications', 'timeFrame': '1 hour', 'description': 'This records any problems that were encountered at the original insertion of the mesh. clinic visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mesh', 'pelvic organ prolapse'], 'conditions': ['Genital Diseases, Female', 'Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time.\n\nRegulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.', 'detailedDescription': 'This will be a consecutive cohort study of patients identified from a surgical database of Perigees performed in a single centre. All patients will have had the procedure performed between 2007 and 2011. This will be a single centre study. The principle investigator has both electronic and hand written records of all Perigee repairs performed since the introduction of this technique in 2007. The patients will be identified from both the paper and electronic databases and cross referenced.\n\nAfter obtained appropriate ethical approval, patients identified as having a perigee mesh inserted will be asked to attend Medway Hospital for a full clinical evaluation. They will be sent a letter with an appointment to come to the hospital. They will be asked to complete the Pelvic floor distress inventory questionnaire to assess their symptoms. They will have a pelvic examination to determine if they have any mesh erosion and will undergo a POP-Q score. This visit will take 1 hour.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients having previously undergone a mesh repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing a perigee procedure after January 2007\n\nExclusion Criteria:\n\n* Patient having non mesh repairs over the same time scale'}, 'identificationModule': {'nctId': 'NCT02642835', 'briefTitle': 'A Long Term Follow up of Anterior Meshes for Recurrent Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Medway NHS Foundation Trust'}, 'officialTitle': 'A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse', 'orgStudyIdInfo': {'id': '9/12/14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vaginal wall mesh', 'type': 'PROCEDURE', 'description': 'retrospective review of case series'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ME5 7NY', 'city': 'Gillingham', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Medway NHS Foundation trust', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}], 'overallOfficials': [{'name': 'Jonathan Duckett, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medway NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medway NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Urogynaecologist', 'investigatorFullName': 'Professor Jonathan Duckett', 'investigatorAffiliation': 'Medway NHS Foundation Trust'}}}}