Overactive Bladder (OAB)NCT03846895
Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)
A study testing Microablative Fractional CO2 laser in people with Overactive Bladder (OAB), run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Microablative Fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 12 May 2018to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Microablative Fractional CO2 laser
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microablative Fractional CO2 laserDevice
Also called SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
3 therapies intravaginally administered will be applied at monthly intervals
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Microablative Fractional CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
3 days voiding diary
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start12 May 2018
- Primary completion15 Sep 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Themos Grigoriadis, National and Kapodistrian University of Athens
- Investigators
- Themos Grigoriadis, Assistant Professor, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846895
- Sponsor's protocol ID
- 303/16-04-2018
- Status last verified
- Sep 2022
- First submitted
- 18 Feb 2019
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40731828
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.
- ClinicalTrials.gov ID
- NCT03846895
- Acronym / sponsor ID
- 303/16-04-2018
- Conditions
- Overactive Bladder (OAB)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 12 May 2018 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Experimental | Device: Microablative Fractional CO2 laserMicroablative 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. |
| Placebo Group | Placebo comparator | Device: Microablative Fractional CO2 laserPlacebo 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- Participants with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microablative Fractional CO2 laserAlso: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy3 therapies intravaginally administered will be applied at monthly intervals | Device | Laser Group, Placebo Group |
Primary outcome
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.
3 days voiding diary
Time frame: 24 months
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)
4 secondary outcomes
King's Health Questionnaire (KHQ)
Time frame: 24 months
Patients Global Impression of Improvement (PGI-I)
Time frame: 24 months
Urogenital Distress Inventory questionaire (UDI-6)
Time frame: 24 months
Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 40731828Kypriotis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Themos Grigoriadis, Assistant Professor principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microablative Fractional CO2 laser in people with Overactive Bladder (OAB), run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive Bladder questionaire (OAB-q) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.