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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
3 therapies intravaginally administered will be applied at monthly intervals
Urogynecological Unit of Alexandra Hospital
Athens, Greece
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.
Time frame: 24 months
3 days voiding diary
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)
Time frame: 24 months
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.
Time frame: 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
Time frame: 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.
Time frame: 24 months
Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)
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It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.
Time frame: 24 months