Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-19 @ 6:54 AM
Study NCT ID:
NCT02716506
Status:
UNKNOWN
Last Update Posted:
2019-06-26
First Post:
2015-11-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nina.mattsson@fimnet.fi', 'phone': '+358407338307', 'title': 'Dr Nina Mattsson', 'organization': 'Kanta-Häme Central Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Symptomatic POP', 'description': 'POP surgery in year 2015\n\nPOP surgery: Any surgical procedure that is done to treat the symptomatic POP', 'otherNumAtRisk': 3512, 'deathsNumAtRisk': 3512, 'otherNumAffected': 353, 'seriousNumAtRisk': 3512, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Minor adverse events', 'notes': 'Clavidien dindo I-III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3512, 'numEvents': 353, 'numAffected': 353}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Calvidien dindo I-II'}], 'seriousEvents': [{'term': 'Serious adverse event (Clavidien dindo IV)', 'notes': 'Clavidien dindo classification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3512, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life After the POP Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic POP', 'description': 'POP surgery in year 2015\n\nPOP surgery: Any surgical procedure that is done to treat the symptomatic POP'}], 'classes': [{'categories': [{'measurements': [{'value': '0.898', 'groupId': 'OG000', 'lowerLimit': '0.894', 'upperLimit': '0.902'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months after the surgery', 'description': 'Quality of life is measured by using 15 dimensional quality of health measurement instrument. Minimum value is 0 and maximum value is 1. Higher scores mean better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of the patients who answered the 15-D questionnaire 24 months after the operation.'}, {'type': 'SECONDARY', 'title': 'Symptoms Related to Pelvic Organ Prolapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic POP', 'description': 'POP surgery in year 2015\n\nPOP surgery: Any surgical procedure that is done to treat the symptomatic POP'}], 'classes': [{'categories': [{'measurements': [{'value': '49.24', 'spread': '44.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months after the surgery', 'description': 'Condition-specific questionnaire Pelvic Floor Distress Inventory (PFDI-20) is used. Minimum value is 0 and maximum value is 300. Higher scores mean more bothersome symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in PFDI-20 scores 24 months after the operation compared to the baseline scores.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symptomatic POP', 'description': 'POP surgery in year 2015\n\nPOP surgery: Any surgical procedure that is done to treat the symptomatic POP'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3515'}]}, {'type': '6 Months', 'achievements': [{'comment': 'Patients that completed the questionnaires six months after the operation.', 'groupId': 'FG000', 'numSubjects': '2528'}]}, {'type': '2 Years', 'achievements': [{'comment': 'Patients that completed the questionnaires two years after the operation.', 'groupId': 'FG000', 'numSubjects': '2351'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2351'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1164'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3512', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Symptomatic POP', 'description': 'Patients that were operated for POP in 2015 in Finland and participated the study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3512', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1764', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1748', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3512', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3512', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3512', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3512', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3512', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3515}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2015-11-10', 'resultsFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-17', 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life After the POP Surgery', 'timeFrame': '24 months after the surgery', 'description': 'Quality of life is measured by using 15 dimensional quality of health measurement instrument. Minimum value is 0 and maximum value is 1. Higher scores mean better outcome.'}], 'secondaryOutcomes': [{'measure': 'Symptoms Related to Pelvic Organ Prolapse', 'timeFrame': '24 months after the surgery', 'description': 'Condition-specific questionnaire Pelvic Floor Distress Inventory (PFDI-20) is used. Minimum value is 0 and maximum value is 300. Higher scores mean more bothersome symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['POP surgery'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '41277806', 'type': 'DERIVED', 'citation': 'Wihersaari O, Karjalainen P, Tolppanen AM, Mattsson N, Jalkanen J, Nieminen K. Prolapse recurrence, methods of reoperation, and long-term mesh complications-A nationwide follow-up study. Acta Obstet Gynecol Scand. 2025 Nov 24. doi: 10.1111/aogs.70083. Online ahead of print.'}, {'pmid': '39752612', 'type': 'DERIVED', 'citation': 'Wihersaari OAE, Karjalainen P, Tolppanen AM, Mattsson N, Nieminen K, Jalkanen J. Quality of Sexual Life Before and After Pelvic Organ Prolapse Surgery. Urogynecology (Phila). 2024 Oct 1;30(10):838-846. doi: 10.1097/SPV.0000000000001568.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse (POP) surgery. In this multi center study the population consists of POP operations done in Finland year 2015.The study is prospective and validated questionnaires are used to measure the symptoms of POP and the quality of life before and six months after the operation. Methods and complications of surgery are reported by doctors in all 40 participant hospitals.', 'detailedDescription': 'Patients awaiting for surgical procedure for a symptomatic pelvic organ prolapse (POP) are recruited for the study. The recruiting is done in 41 hospitals in Finland, at gynecological outpatient clinics. Participants are given information of the study and give a written approval to join the study. Participants are asked to fill in questionnaires, that measure the quality of life. Three validated questionnaires are used: Pelvic Floor Distress Inventory PFDI-20, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire PISQ-12 and health-related quality of life instrument 15D. These questionnaires are sent to participants 6 months, 2 and 5 years after the surgical treatment. The participants are also asked to report adverse effects related to the treatment and their satisfaction to the treatment. Information about the surgical procedure (i.e. type and duration of the procedure, blood loss, antibiotic and thrombosis prophylaxis) by the operating doctors. Both immediate and delayed treatment-related adverse effects are also reported by the doctors. Data is partly collected by questionnaires filled in internet. All the collected data is protected by high security and coded before analyses. Permission of protocol used in this study is given by the Ethical Committee of University of Eastern Finland and Finnish National Institute for Health and Welfare.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with a symptomatic pelvic organ prolapse (POP) operated in year 2015 in Finland', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic pelvic organ prolapse\n* Mental and psychological ability to understand the study information and to give an approval\n* Knowledge of Finnish or Swedish language\n\nExclusion Criteria:\n\n* Other than Finnish or Swedish language\n* Psychological disability to understand the study information'}, 'identificationModule': {'nctId': 'NCT02716506', 'briefTitle': 'FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015', 'organization': {'class': 'OTHER', 'fullName': 'Society for Gynecological Surgery in Finland'}, 'officialTitle': 'Finnish Pelvic Organ Prolapse Surgery Survey 2015: Incidence, Methods, Complications and Effect on Quality of Life of Pelvic Organ Prolapse Operations in Finland in 2015', 'orgStudyIdInfo': {'id': 'Finpop 2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic POP', 'description': 'POP surgery in year 2015', 'interventionNames': ['Procedure: POP surgery']}], 'interventions': [{'name': 'POP surgery', 'type': 'PROCEDURE', 'description': 'Any surgical procedure that is done to treat the symptomatic POP', 'armGroupLabels': ['Symptomatic POP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70100', 'city': 'Kuopio', 'state': 'Eastern Finland', 'country': 'Finland', 'facility': 'UEF', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Päivi Härkki, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Finnish Society of Gynecological Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Society for Gynecological Surgery in Finland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nina Mattsson', 'investigatorAffiliation': 'Society for Gynecological Surgery in Finland'}}}}