Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-24 @ 4:44 AM
Study NCT ID:
NCT04029168
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2019-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic Floor Distress Inventory (PFDI-20)', 'timeFrame': 'change from the baseline till 6 months post treatment', 'description': 'Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': 'change from the baseline till 6 month post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Marshall-Bonney test', 'timeFrame': 'change from the baseline till 6 months post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}], 'secondaryOutcomes': [{'measure': 'Pelvic Floor Distress Inventory (PFDI-20)', 'timeFrame': '3 months post treatment', 'description': 'Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI-20)', 'timeFrame': '12 months post treatment', 'description': 'Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI-20)', 'timeFrame': 'change from the baseline till 3 months post treatment', 'description': 'Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI-20)', 'timeFrame': 'change from the baseline till 12 months post treatment', 'description': 'Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '3 month post treatment', 'description': 'Distress assessment range 0-10, higher numbers represent better outcomes'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '6 months post treatment', 'description': 'Distress assessment range 0-10, higher numbers represent better outcomes'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '12 months post treatment', 'description': 'Distress assessment range 0-10, higher numbers represent better outcomes'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'change from the baseline till 3 months post treatment', 'description': 'Distress assessment range 0-10, higher numbers represent better outcomes'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'change from the baseline till 6 months post treatment', 'description': 'Distress assessment range 0-10, higher numbers represent better outcomes'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'change from the baseline till 12 months post treatment', 'description': 'Distress assessment range 0-10, higher numbers represent better outcomes'}, {'measure': 'PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)', 'timeFrame': '3 month post treatment', 'description': 'Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact'}, {'measure': 'PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)', 'timeFrame': '6 months post treatment', 'description': 'Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact'}, {'measure': 'PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)', 'timeFrame': '12 months post treatment', 'description': 'Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact'}, {'measure': 'PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)', 'timeFrame': 'change from the baseline till 3 months post treatment', 'description': 'Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact'}, {'measure': 'PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)', 'timeFrame': 'change from the baseline till 6 months post treatment', 'description': 'Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact'}, {'measure': 'PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)', 'timeFrame': 'change from the baseline till 12 months post treatment', 'description': 'Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact'}, {'measure': 'Incontinence impact Questionnaire-Short Form (IIQ-7 SF)', 'timeFrame': '3 months post treatment', 'description': 'To measure the impact of urinary incontinence on activities, roles and emotional states'}, {'measure': 'Incontinence impact Questionnaire-Short Form (IIQ-7 SF)', 'timeFrame': '6 months post treatment', 'description': 'To measure the impact of urinary incontinence on activities, roles and emotional states'}, {'measure': 'Incontinence impact Questionnaire-Short Form (IIQ-7 SF)', 'timeFrame': '12 months post treatment', 'description': 'To measure the impact of urinary incontinence on activities, roles and emotional states'}, {'measure': 'Incontinence impact Questionnaire-Short Form (IIQ-7 SF)', 'timeFrame': 'change from the baseline till 3 months post treatment', 'description': 'To measure the impact of urinary incontinence on activities, roles and emotional states'}, {'measure': 'Incontinence impact Questionnaire-Short Form (IIQ-7 SF)', 'timeFrame': 'change from the baseline till 6 months post treatment', 'description': 'To measure the impact of urinary incontinence on activities, roles and emotional states'}, {'measure': 'Incontinence impact Questionnaire-Short Form (IIQ-7 SF)', 'timeFrame': 'change from the baseline till 12 months post treatment', 'description': 'To measure the impact of urinary incontinence on activities, roles and emotional states'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': 'at 1 month post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': '3 months post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': '12 months post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': 'change from the baseline till 3 month post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': 'change from the baseline till 12 month post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': 'change from the baseline till 1 month post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Marshall-Bonney test', 'timeFrame': 'at 1 month post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}, {'measure': 'Marshall-Bonney test', 'timeFrame': '3 months post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}, {'measure': 'Marshall-Bonney test', 'timeFrame': '12 months post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}, {'measure': 'Marshall-Bonney test', 'timeFrame': 'change from the baseline till 3 months post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}, {'measure': 'Marshall-Bonney test', 'timeFrame': 'change from the baseline till 1 month post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}, {'measure': 'Marshall-Bonney test', 'timeFrame': 'change from the baseline till 12 months post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI-20)', 'timeFrame': '6 months post treatment', 'description': 'Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.'}, {'measure': 'Pelvic floor organ prolapse quantification (POP-Q)', 'timeFrame': '6 months post treatment', 'description': 'Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes'}, {'measure': 'Marshall-Bonney test', 'timeFrame': '6 months post treatment', 'description': 'Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence', 'Pelvic Organ Prolapse', 'Pelvic Floor Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of the study is evaluation of the efficiency of pelvic floor muscles in the context of surgical outcomes in the treatment of stress urinary incontinence and pelvic organ prolapse.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with stress urinary incontinence and pelvic organ prolapse', 'genderDescription': 'participant eligibility is based on self-representation of gender identity.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premenopausal and postmenopausal women\n* stress urinary incontinence\n* pelvic organ prolapse\n\nExclusion Criteria:\n\n\\- previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse'}, 'identificationModule': {'nctId': 'NCT04029168', 'briefTitle': 'Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Żelazna Medical Centre, LLC'}, 'officialTitle': 'Pelvic Floor Muscles Efficiency as an Independent Factor of Therapeutic Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse', 'orgStudyIdInfo': {'id': 'PN/25/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pelvic floor surgery', 'description': 'The group will consist of females with pelvic floor disorders (pelvic organ prolapse, stress urinary incontinence) qualified for pelvic floor surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-004', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Medyczne "ŻELAZNA"', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Dorota Sys, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre of Postgraduate Medical Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Żelazna Medical Centre, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}