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

The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

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 Overview

• Status: Completed
• Conditions: Overactive Bladder (OAB)
• Intervention / Treatment: Device: Microablative Fractional CO2 laser

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Urogynecological Unit of Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Microablative Fractional CO2 laser; 3 therapies intravaginally administered will be applied at monthly intervals; Other Names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Placebo Comparator: 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.	Device: Microablative Fractional CO2 laser; 3 therapies intravaginally administered will be applied at monthly intervals; Other Names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
3 days voiding diary	Assesses bladder function (frequency of micturition, urgency and urinary incontinence)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	24 months
Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)	It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.	24 months

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Principal Investigator: Themos Grigoriadis, Assistant Professor, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2018
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 303/16-04-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No