Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-04 @ 5:10 PM
Study NCT ID:
NCT03846895
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2019-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-04', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overactive Bladder questionaire (OAB-q)', 'timeFrame': '24 months', 'description': 'It consists of an 8 item symptom bother scale section and a 25 item health related quality of life scale section (HRQL). Scores of each domain of the 2 sections range from 0 to 100. Higher scores indicate higher impact of overactive bladder symptoms.'}, {'measure': '3 days voiding diary', 'timeFrame': '24 months', 'description': 'Assesses bladder function (frequency of micturition, urgency and urinary incontinence)'}], 'secondaryOutcomes': [{'measure': "King's Health Questionnaire (KHQ)", 'timeFrame': '24 months', 'description': 'It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.'}, {'measure': 'Patients Global Impression of Improvement (PGI-I)', 'timeFrame': '24 months', 'description': 'It is a single question with 7 possible answers. Patients will chose the answer that applies at their impression of improvement after the laser therapy'}, {'measure': 'Urogenital Distress Inventory questionaire (UDI-6)', 'timeFrame': '24 months', 'description': 'It is a 6 item questionaire evaluating symptom distress of urinary incontinence and its impact on daily life. Scores range from 0 to 100. Higher scores indicate higher impact of urinary incontinence.'}, {'measure': 'Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)', 'timeFrame': '24 months', 'description': 'It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder (OAB)']}, 'referencesModule': {'references': [{'pmid': '40731828', 'type': 'DERIVED', 'citation': 'Kypriotis K, Prodromidou A, Athanasiou S, Zacharakis D, Kathopoulis N, Douligeris A, Athanasiou V, Michala L, Grigoriadis T. Is the Addition of CO2 Laser to beta3-Adrenoceptor Agonist Mirabegron Effective in the Management of Overactive Bladder? Results of a Randomized Controlled Trial. Medicina (Kaunas). 2025 Jun 30;61(7):1198. doi: 10.3390/medicina61071198.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women (≥ 12 months of amenorrhea or FSH ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for OAB\n* Overactive bladder syndrome (OAB)\n\n * ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h\n * At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.\n\nExclusion Criteria:\n\n* Participants with:\n\n * Pelvic Organ Prolapse (POP) \\> stage II of the pelvic organ prolapse quantitation system (POP-Q)\n * Post void residual volume \\> 200 ml (measured by ultrasound)\n * Use of moisturizers or lubricants the last month\n * Use of vaginal estrogen in the last 6 months\n * Use of drugs for urinary incontinence\n * Use of psychotropic drugs\n * Symptomatic urinary tract infection\n * Active genital infection\n * Kidney or liver disease\n * Abnormal cardiac conduction, rate or rythm disorders\n * Diabetic neuropathy\n * Myasthenia gravis\n * History of malignant disease\n * Previous radio-chemo therapy'}, 'identificationModule': {'nctId': 'NCT03846895', 'briefTitle': 'Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.', 'orgStudyIdInfo': {'id': '303/16-04-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Group', 'description': 'Microablative Fractional CO2 laser therapy at monthly intervals.\n\nThe laser parameters that will be used are the following:\n\n1. Power: 40 watts,\n2. Dwell time:1000μs,\n3. Spacing 1000 μm,\n4. Depth: SmartStak parameter 3\n5. D-pulse mode.', 'interventionNames': ['Device: Microablative Fractional CO2 laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo CO2 laser therapies at monthly intervals.\n\nThe laser parameters that will be used are the following:\n\n1. Power: 0.5 watts,\n2. Dwell time:1000μs,\n3. Spacing 1000 μm,\n4. Depth: SmartStak parameter 1,\n5. Smart-pulse mode.', 'interventionNames': ['Device: Microablative Fractional CO2 laser']}], 'interventions': [{'name': 'Microablative Fractional CO2 laser', 'type': 'DEVICE', 'otherNames': ['SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy'], 'description': '3 therapies intravaginally administered will be applied at monthly intervals', 'armGroupLabels': ['Laser Group', 'Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Urogynecological Unit of Alexandra Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Themos Grigoriadis, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National and Kapodistrian University of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Themos Grigoriadis', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}