Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 5:42 AM
Study NCT ID:
NCT05832268
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-02
First Post:
2023-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.', 'timeFrame': '5- 20 years', 'description': 'Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7).'}], 'secondaryOutcomes': [{'measure': 'Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury', 'timeFrame': '5-20 years', 'description': 'Number of participants who report complaints about urinary incontinence, measured by study questionnaires (PFIQ-7, NFIR, PFDI-20).'}, {'measure': 'The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury.', 'timeFrame': '5-20 years', 'description': 'Number of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstetric Anal Sphincter Injury', 'Anal Incontinence', 'Urinary Incontinence', 'Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury.\n\nThe main questions we want to answer is:\n\n* can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life?\n* can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction?\n* should we recommend these women to have a caesarian section instead of a new vaginal delivery?\n\nParticipants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction.\n\nResearchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be women who had two or more vaginal deliveries at Oslo Universitetssykehus in the time period 2002-2018.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury\n* control group: Two or more vaginal deliveries without obstetric anal sphincter injury\n\nExclusion Criteria:\n\n* under 18 years\n* consent incompetency\n* Obstetric anal sphincter injury in subsequent pregnancies\n* caesarian section in subsequent pregnancy'}, 'identificationModule': {'nctId': 'NCT05832268', 'acronym': 'PFF', 'briefTitle': 'Pelvic Floor Function After Obstetric Injury to the Anal Sphincter', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The Pelvic Floor Future Study', 'orgStudyIdInfo': {'id': '2019/654'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sphincter damage', 'description': 'Women who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury', 'interventionNames': ['Other: Obstetric Anal Sphincter Injury']}, {'label': 'Controls', 'description': 'Women who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter', 'interventionNames': ['Other: Obstetric Anal Sphincter Injury']}], 'interventions': [{'name': 'Obstetric Anal Sphincter Injury', 'type': 'OTHER', 'description': 'We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively', 'armGroupLabels': ['Controls', 'Sphincter damage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0464', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Kristine A Kilaas, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Rune Svenningsen, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Sissel Oversand', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The participant data will only be available to the researchers in charge of this project'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sissel Oversand', 'investigatorAffiliation': 'Oslo University Hospital'}}}}