Status:
COMPLETED
Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Overactive Bladder (OAB)
Eligibility:
FEMALE
40-75 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03846895
Start Date
May 12 2018
End Date
February 15 2022
Last Update
September 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Urogynecological Unit of Alexandra Hospital
Athens, Greece, 11528