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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-12

Study Completion Date

2022-02-15

Brief Summary

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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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Detailed Description

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Conditions

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Overactive Bladder (OAB)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Laser Group

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.

Group Type EXPERIMENTAL

Microablative Fractional CO2 laser

Intervention Type DEVICE

3 therapies intravaginally administered will be applied at monthly intervals

Placebo Group

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.

Group Type PLACEBO_COMPARATOR

Microablative Fractional CO2 laser

Intervention Type DEVICE

3 therapies intravaginally administered will be applied at monthly intervals

Interventions

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Microablative Fractional CO2 laser

3 therapies intravaginally administered will be applied at monthly intervals

Intervention Type DEVICE

Other Intervention Names

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SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes