Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT03613350
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence Rates of USI, BO, DO and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052858', 'term': 'Cystocele'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'USI', 'timeFrame': 'Between November 2011 and January 2017', 'description': 'Urodynamic stress incontinence was noted during examination'}, {'measure': 'BO/DO', 'timeFrame': 'Between November 2011 and January 2017', 'description': 'Bladder oversensitivity/detrusor overactivity was noted during examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystocele', 'Urodynamic stress incontinence', 'Detrusor overactivity', 'Pad test', 'Urodynamic study'], 'conditions': ['Lower Urinary Tract Symptom in Severe Cystocele Women']}, 'descriptionModule': {'briefSummary': 'Prevalence rates of urodynamic stress incontinence (USI), bladder oversensitivity (BO) /detrusor overactivity (DO) or both and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation. Thus, the aim of this study was to elucidate the above findings and between-group associations.', 'detailedDescription': "Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction. BO was defined as \\<300 mL of the volume at strong desire to void during filling cystometry. Those women without USI, BO or DO were allocated into the no demonstrated USI+BO/DO group."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with ≥stage II cystocele.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>20y/o\n2. Severe cystocele, ie, more than stage 2\n3. Complete pad test and urodynamic study\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Urinary tract infection\n3. Had received pelvic reconstruction'}, 'identificationModule': {'nctId': 'NCT03613350', 'briefTitle': 'Prevalence Rates of USI, BO, DO and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Prevalence Rates of Urodynamic Stress Incontinence, Bladder Oversensitivity/Detrusor Overactivity or Both and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele', 'orgStudyIdInfo': {'id': '201805024RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Urodynamic stress incontinence', 'description': 'Urodynamic study incontinence Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction.', 'interventionNames': ['Diagnostic Test: Pad test']}, {'label': 'USI+BO/DO', 'description': 'Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction.BO was defined as \\<300 mL of the volume at strong desire to void during filling cystometry. Detrusor overactivity was defined as evidence of spontaneous detrusor contractions occurring during bladder filling or an uninhibited detrusor contraction occurring at a cystometric capacity that usually results in voiding.', 'interventionNames': ['Diagnostic Test: Pad test']}, {'label': 'BO/DO', 'description': 'Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. BO was defined as \\<300 mL of the volume at strong desire to void during filling cystometry. Detrusor overactivity was defined as evidence of spontaneous detrusor contractions occurring during bladder filling or an uninhibited detrusor contraction occurring at a cystometric capacity that usually results in voiding.', 'interventionNames': ['Diagnostic Test: Pad test']}, {'label': 'No demonstrated USI+BO/DO', 'description': 'Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. No urodynamic stress incontinence, no bladder oversensitivity nor detrusor overactivity was noted in this group.', 'interventionNames': ['Diagnostic Test: Pad test']}], 'interventions': [{'name': 'Pad test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['urodynamic study'], 'description': '20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.', 'armGroupLabels': ['BO/DO', 'No demonstrated USI+BO/DO', 'USI+BO/DO', 'Urodynamic stress incontinence']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}