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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Group | Experimental | Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following:
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| Placebo Group | Placebo Comparator | Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microablative Fractional CO2 laser | Device | 3 therapies intravaginally administered will be applied at monthly intervals |
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| Measure | Description | Time Frame |
|---|---|---|
| Overactive Bladder questionaire (OAB-q) | 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. | 24 months |
| 3 days voiding diary | Assesses bladder function (frequency of micturition, urgency and urinary incontinence) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| King's Health Questionnaire (KHQ) | 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. |
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Inclusion Criteria:
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
Overactive bladder syndrome (OAB)
Exclusion Criteria:
Participants with:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Themos Grigoriadis, Assistant Professor | National and Kapodistrian University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urogynecological Unit of Alexandra Hospital | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40731828 | Derived | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 24 months |
| Patients Global Impression of Improvement (PGI-I) | 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 | 24 months |
| Urogenital Distress Inventory questionaire (UDI-6) | 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. | 24 months |
| Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7) | It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings. | 24 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |