The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Overactive Bladder questionaire (OAB-q)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Laser Group
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.
Intervention: Microablative Fractional CO2 laser (Device)
Placebo Group
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.
Intervention: Microablative Fractional CO2 laser (Device)
Outcomes
Primary Outcomes
Overactive Bladder questionaire (OAB-q)
Time Frame: 24 months
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.
3 days voiding diary
Time Frame: 24 months
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)
Secondary Outcomes
- Patients Global Impression of Improvement (PGI-I)(24 months)
- Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)(24 months)
- King's Health Questionnaire (KHQ)(24 months)
- Urogenital Distress Inventory questionaire (UDI-6)(24 months)
Investigators
Themos Grigoriadis
Assistant Professor
National and Kapodistrian University of Athens