Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)

Study Overview
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Brief Summary
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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.

Official Title
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The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

Conditions
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Overactive Bladder (OAB)

Intervention / Treatment
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* Device: Microablative Fractional CO2 laser


Participation Criteria
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Eligibility Criteria
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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) ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h 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. Exclusion Criteria: Participants with: Pelvic Organ Prolapse (POP) > stage II of the pelvic organ prolapse quantitation system (POP-Q) Post void residual volume > 200 ml (measured by ultrasound) Use of moisturizers or lubricants the last month Use of vaginal estrogen in the last 6 months Use of drugs for urinary incontinence Use of psychotropic drugs Symptomatic urinary tract infection Active genital infection Kidney or liver disease Abnormal cardiac conduction, rate or rythm disorders Diabetic neuropathy Myasthenia gravis History of malignant disease Previous radio-chemo therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Group<br>Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following: Power: 40 watts, Dwell time:1000μs, Spacing 1000 μm, Depth: SmartStak parameter 3 D-pulse mode. | Device: Microablative Fractional CO2 laser<br>* 3 therapies intravaginally administered will be applied at monthly intervals<br>* Other names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy;|
| Placebo Comparator: Placebo Group<br>Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following: Power: 0.5 watts, Dwell time:1000μs, Spacing 1000 μm, Depth: SmartStak parameter 1, Smart-pulse mode. | Device: Microablative Fractional CO2 laser<br>* 3 therapies intravaginally administered will be applied at monthly intervals<br>* Other names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |