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

Primary Purpose

Overactive Bladder (OAB)

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Microablative Fractional CO2 laser
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder (OAB)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Urogynecological Unit of Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
3 days voiding diary
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)

Secondary Outcome Measures

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.
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
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.
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.

Full Information

First Posted
February 18, 2019
Last Updated
September 4, 2022
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03846895
Brief Title
Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)
Official Title
The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2018 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder (OAB)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Microablative Fractional CO2 laser
Other Intervention Name(s)
SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Intervention Description
3 therapies intravaginally administered will be applied at monthly intervals
Primary Outcome Measure Information:
Title
Overactive Bladder questionaire (OAB-q)
Description
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.
Time Frame
24 months
Title
3 days voiding diary
Description
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
King's Health Questionnaire (KHQ)
Description
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.
Time Frame
24 months
Title
Patients Global Impression of Improvement (PGI-I)
Description
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
Time Frame
24 months
Title
Urogenital Distress Inventory questionaire (UDI-6)
Description
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.
Time Frame
24 months
Title
Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)
Description
It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, Assistant Professor
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urogynecological Unit of Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

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

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