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

NCT03846895 | Completed DMC

• 1 other identifier: 303/16-04-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• King's Health Questionnaire (KHQ)

  24 months

• Patients Global Impression of Improvement (PGI-I)

  24 months

• Urogenital Distress Inventory questionaire (UDI-6)

  24 months

• Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)

  24 months

Study Arms (2)

Laser Group

EXPERIMENTAL

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.

Device: Microablative Fractional CO2 laser

Placebo Group

PLACEBO COMPARATOR

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.

Device: Microablative Fractional CO2 laser

Interventions

Microablative Fractional CO2 laser DEVICE

3 therapies intravaginally administered will be applied at monthly intervals

Also known as: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

Laser Group; Placebo Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

Location

Related Publications (1)

• Kypriotis K, Prodromidou A, Athanasiou S, Zacharakis D, Kathopoulis N, Douligeris A, Athanasiou V, Michala L, Grigoriadis T. Is the Addition of CO2 Laser to beta3-Adrenoceptor Agonist Mirabegron Effective in the Management of Overactive Bladder? Results of a Randomized Controlled Trial. Medicina (Kaunas). 2025 Jun 30;61(7):1198. doi: 10.3390/medicina61071198.

  PMID: 40731828 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Themos Grigoriadis, Assistant Professor

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: May 12, 2018
• Primary Completion: September 15, 2021
• Study Completion: February 15, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

GR (1)