Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-06 @ 6:19 PM
Study NCT ID:
NCT03591393
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2018-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}], 'ancestors': [{'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010147', 'term': 'Pain Measurement'}], 'ancestors': [{'id': 'D009460', 'term': 'Neurologic Examination'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-07-06', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Body Image during and after pregnancy', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'Body Image Disturbance Questionnaire Score: 7-item questionnaire, each item is scored on a 5-point Likert-scale (1=no disturbance at all; 5=extreme disturbance), the final score is the mean of the 7-item ordinal scores.'}], 'secondaryOutcomes': [{'measure': 'Urethra mobility in cm', 'timeFrame': '11-13 weeks gestation', 'description': 'Transperineal ultrasound'}, {'measure': 'Urethra mobility in cm', 'timeFrame': '28-33 weeks gestation', 'description': 'Transperineal ultrasound'}, {'measure': 'genital hiatus in cm^2', 'timeFrame': '11-13 weeks gestation', 'description': 'Transperineal ultrasound'}, {'measure': 'genital hiatus in cm^2', 'timeFrame': '28-33 weeks gestation', 'description': 'Transperineal ultrasound'}, {'measure': 'levator ani avulsion', 'timeFrame': '11-13 weeks gestation', 'description': 'TUI sequence'}, {'measure': 'levator ani avulsion', 'timeFrame': '28-33 weeks gestation', 'description': 'TUI sequence'}, {'measure': 'anal sphincter injury', 'timeFrame': '11-13 weeks gestation', 'description': 'TUI sequence'}, {'measure': 'anal sphincter injury', 'timeFrame': '28-33 weeks gestation', 'description': 'TUI sequence'}, {'measure': 'Urinary Incontinence', 'timeFrame': '11-13 weeks gestation', 'description': 'International Consultation Incontinence Questionnaire - short form'}, {'measure': 'Urinary Incontinence', 'timeFrame': '28-33 weeks gestation', 'description': 'International Consultation Incontinence Questionnaire - short form'}, {'measure': 'Urinary Incontinence', 'timeFrame': '3 months postpartum', 'description': 'International Consultation Incontinence Questionnaire - short form'}, {'measure': 'Urinary Incontinence', 'timeFrame': '12 months postpartum', 'description': 'International Consultation Incontinence Questionnaire - short form'}, {'measure': 'Anal Incontinence', 'timeFrame': '11-13 weeks gestation', 'description': 'wexner score: 5-items questionnaire measuring the frequency of complaints. Each item is scored 0-4 (0=never, 4=always). The final score is the sum of the scores of the 5 items (total score 0-20)'}, {'measure': 'Anal Incontinence', 'timeFrame': '28-33 weeks gestation', 'description': 'wexner score: 5-items questionnaire measuring the frequency of complaints. Each item is scored 0-4 (0=never, 4=always). The final score is the sum of the scores of the 5 items (total score 0-20)'}, {'measure': 'Anal Incontinence', 'timeFrame': '3 months postpartum', 'description': 'wexner score: 5-items questionnaire measuring the frequency of complaints. Each item is scored 0-4 (0=never, 4=always). The final score is the sum of the scores of the 5 items (total score 0-20)'}, {'measure': 'Anal Incontinence', 'timeFrame': '12 months postpartum', 'description': 'wexner score: 5-items questionnaire measuring the frequency of complaints. Each item is scored 0-4 (0=never, 4=always). The final score is the sum of the scores of the 5 items (total score 0-20)'}, {'measure': 'Pelvic Organ Prolapse', 'timeFrame': '11-13 weeks gestation', 'description': 'Pelvic Organ Prolapse Distress Inventory'}, {'measure': 'Pelvic Organ Prolapse', 'timeFrame': '28-33 weeks gestation', 'description': 'Pelvic Organ Prolapse Distress Inventory'}, {'measure': 'Pelvic Organ Prolapse', 'timeFrame': '3 months postpartum', 'description': 'Pelvic Organ Prolapse Distress Inventory'}, {'measure': 'Pelvic Organ Prolapse', 'timeFrame': '12 months postpartum', 'description': 'Pelvic Organ Prolapse Distress Inventory'}, {'measure': 'Sexual function', 'timeFrame': '11-13 weeks gestation', 'description': 'POP/UI Sexual Questionnaire - IUGA revised'}, {'measure': 'Sexual function', 'timeFrame': '28-33 weeks gestation', 'description': 'POP/UI Sexual Questionnaire - IUGA revised'}, {'measure': 'Sexual function', 'timeFrame': '3 months postpartum', 'description': 'POP/UI Sexual Questionnaire - IUGA revised'}, {'measure': 'Sexual function', 'timeFrame': '12 months postpartum', 'description': 'POP/UI Sexual Questionnaire - IUGA revised'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Image', 'Urinary Incontinence', 'Anal Incontinence', 'Anorectal Disorder', 'Constipation', 'Pelvic Organ Prolapse', 'Sexual Dysfunction', 'Pregnancy Related', 'Postpartum Disorder']}, 'referencesModule': {'references': [{'pmid': '28447919', 'type': 'RESULT', 'citation': 'Lagaert L, Weyers S, Van Kerrebroeck H, Elaut E. Postpartum dyspareunia and sexual functioning: a prospective cohort study. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):200-206. doi: 10.1080/13625187.2017.1315938. Epub 2017 Apr 27.'}, {'pmid': '19941278', 'type': 'RESULT', 'citation': 'Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.'}, {'pmid': '26113145', 'type': 'RESULT', 'citation': 'Reimers C, Staer-Jensen J, Siafarikas F, Saltyte-Benth J, Bo K, Ellstrom Engh M. Change in pelvic organ support during pregnancy and the first year postpartum: a longitudinal study. BJOG. 2016 Apr;123(5):821-9. doi: 10.1111/1471-0528.13432. Epub 2015 Jun 26.'}, {'pmid': '18089200', 'type': 'RESULT', 'citation': 'Skouteris H, Carr R, Wertheim EH, Paxton SJ, Duncombe D. A prospective study of factors that lead to body dissatisfaction during pregnancy. Body Image. 2005 Dec;2(4):347-61. doi: 10.1016/j.bodyim.2005.09.002. Epub 2005 Nov 21.'}, {'pmid': '19129334', 'type': 'RESULT', 'citation': 'Clark A, Skouteris H, Wertheim EH, Paxton SJ, Milgrom J. The relationship between depression and body dissatisfaction across pregnancy and the postpartum: a prospective study. J Health Psychol. 2009 Jan;14(1):27-35. doi: 10.1177/1359105308097940.'}, {'pmid': '8416784', 'type': 'RESULT', 'citation': 'Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.'}, {'pmid': '10522604', 'type': 'RESULT', 'citation': 'Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.'}, {'pmid': '15227649', 'type': 'RESULT', 'citation': 'Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.'}, {'pmid': '24445668', 'type': 'RESULT', 'citation': 'Utomo E, Blok BF, Steensma AB, Korfage IJ. Validation of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) in a Dutch population. Int Urogynecol J. 2014 Apr;25(4):531-44. doi: 10.1007/s00192-013-2263-z. Epub 2014 Jan 21.'}, {'pmid': '20350640', 'type': 'RESULT', 'citation': 'Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.'}]}, 'descriptionModule': {'briefSummary': 'The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image.\n\nThis is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan.\n\nThe presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function.\n\nThe body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire.\n\nThe anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or = 18 years\n* dutch-speaking\n* ongoing pregnancy before 14 weeks GA\n* intending to deliver in UZ Leuven\n* ICF\n\nExclusion Criteria:\n\n* age \\< 18 years\n* not dutch-speaking\n* non evolutive pregnancy\n* pregnancy over 14 weeks GA\n* intention to deliver elsewhere'}, 'identificationModule': {'nctId': 'NCT03591393', 'acronym': 'PFD-BI', 'briefTitle': 'Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function - A Prospective Study Through Pregnancy and Post-partum', 'orgStudyIdInfo': {'id': 'S60939'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant women', 'description': '* questionnaire at 1st and 3rd trimester, 10-12 weeks postpartum and 12 months postpartum\n* pelvic floor ultrasound at 1st trimester and at 3rd trimester', 'interventionNames': ['Diagnostic Test: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['pelvic floor ultrasound'], 'description': 'Validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function.\n\nThe body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire.', 'armGroupLabels': ['Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Jan Deprest, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}