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

National and Kapodistrian University of Athens

Status: Completed

Conditions: Overactive Bladder (OAB)

Treatments: Device: Microablative Fractional CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03846895

303/16-04-2018

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Laser Group

Experimental group

Description:

Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following: 1. Power: 40 watts, 2. Dwell time:1000μs, 3. Spacing 1000 μm, 4. Depth: SmartStak parameter 3 5. D-pulse mode.

Treatment:

Device: Microablative Fractional CO2 laser

Placebo Group

Placebo Comparator group

Description:

Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following: 1. Power: 0.5 watts, 2. Dwell time:1000μs, 3. Spacing 1000 μm, 4. Depth: SmartStak parameter 1, 5. Smart-pulse mode.

Treatment:

Device: Microablative Fractional CO2 laser