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NCT Number: NCT03846895

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

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microablative Fractional CO2 laser

Device

3 therapies intravaginally administered will be applied at monthly intervals

Other names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

Primary outcomes

  1. Overactive Bladder questionaire (OAB-q)

    Time frame: 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.

  2. 3 days voiding diary

    Time frame: 24 months

    Assesses bladder function (frequency of micturition, urgency and urinary incontinence)

Secondary outcomes

  1. King's Health Questionnaire (KHQ)

    Time frame: 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.

  2. Patients Global Impression of Improvement (PGI-I)

    Time frame: 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

  3. Urogenital Distress Inventory questionaire (UDI-6)

    Time frame: 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.

  4. Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)

    Time frame: 24 months

    It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 20, 2019
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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