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

Not Applicable

Completed

• Conditions: Overactive Bladder (OAB)
• Interventions: Device: Microablative Fractional CO2 laser

• Registration Number: NCT03846895
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-12
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2021-09-15
• Study Completion: 2022-02-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Microablative Fractional CO2 laser	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.
Laser Group	Microablative Fractional CO2 laser	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.

Primary Outcome Measures

Name	Time	Method
Overactive Bladder questionaire (OAB-q)	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	24 months	Assesses bladder function (frequency of micturition, urgency and urinary incontinence)

Secondary Outcome Measures

Name	Time	Method
Patients Global Impression of Improvement (PGI-I)	24 months	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
Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)	24 months	It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.
King's Health Questionnaire (KHQ)	24 months	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.
Urogenital Distress Inventory questionaire (UDI-6)	24 months	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.

Trial Locations

Locations (1)

Urogynecological Unit of Alexandra Hospital; 🇬🇷 Athens, Greece