Vaginal AtrophyNCT03956563
Effect of Hybrid Laser 10600+1540 nm on GSM
A study testing Youlaser MT Group 2 and Youlaser MT Group 1 in people with Vaginal Atrophy and Genitourinary Disease, run by Quanta System, S.p.A. at 1 site in Spain.
Trial summary
The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment. The secondary objectives are: 1. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Vaginal Atrophy, Genitourinary Disease
- What is being tested?
- Youlaser MT Group 2 and Youlaser MT Group 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2019to 15 Aug 2020
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal women (defined as ³1 year without menstruation until 65 years of age and no more than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness, burning, itching or dyspareunia ) Atrophic vaginal epithelium measured with the VMV values of 0-49%
- To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
- Women able to understand , accept and signed the Informed Consent.
- Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.
Who cannot join
- VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
- Impossibility of introducing the laser device
- History or other energy-based vaginal therapy within 6 months prior to enrollment.
- Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
- Being on regular and effective topical estrogen therapy within the last 3 months.
- Being on concomitant anticoagulants therapy .
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- Patients suffering of epileptic attacks and immunosuppressive diseases.
- Daily and effective use of moisturizers, lubricants or probiotics.
- Previous pelvic radiotherapy or brachytherapy
- Gynecologic or rectal cancer less than 5 years ago
- Breast cancer with antiestrogenic therapy
- Bladder emptying dysfunction.
- Women operated on UI.
- Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises.
- Genital prolapse grade III or higher, according to the simplified POPQ classification.
- Being on effective pharmacological treatment for overactive bladder.
- Taking diuretics.
- Patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's)
- Insulin-dependent diabetes mellitus (IDDM) or non-dependent insulin poorly controlled.
- Body Mass Index (BMI) > 40 kg/m2
- Active urinary tract infection
- Hematuria.
- Women who present active or recurrent genital herpes.
- Undiagnosed metrorrhagia
- Abnormal last cervical cytology
- Developmental disability, cognitive impairment and/or serious mental health illness.
- Language barrier.
- Women who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus
Reus, 43204
Juan Salinas Peña, MD., + 34 977 310 300, jrsalinas2@gmail.com
About this study
Official title: Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause
The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment.
The secondary objectives are:
Read more
- Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months.
- Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment.
- To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment
- For the GSM symptoms
- For the urinary symptoms and UI
- To assess the patient's satisfaction with the laser treatment.
- For the GSM symptoms
- For the urinary symptoms and UI.
- Conditions
- Vaginal Atrophy, Genitourinary Disease
- Being tested
- Youlaser MT Group 2, Youlaser MT Group 1
- Medical subject headings
- Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youlaser MT Group 2Device
Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications.
Each patient in the control arm will receive 3 simulated laser treatments every 30 days.
A placebo consists in a sham device laser that simulates the acoustic signal even if it does not deliver any laser radiation to the subject.
Youlaser MT Group 1Device
Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications.
Each patient in the active arm will receive 3 laser treatments with the laser: one treatment administration every 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment arm | Active comparator | Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment Receives: Device: Youlaser MT Group 1 |
| Control arm | Sham comparator | Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment Receives: Device: Youlaser MT Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrophic vaginal epithelium change
The primary efficacy outcome measure in this study is to obtain on the atrophic vaginal epithelium at 3 months after the last laser treatment, values going from absent/low estrogenization (0-49%) to moderate or high estrogenization (50-64%) measured with VMV. The results will be compared between the treatment and the control arm.
Measured: 3 months and 9 months post laser treatments
Secondary outcomes (8)
Treatment area success for GSM #1
Change to vaginal pH<5
Measured: 3 months and 9 months post laser treatments
Treatment area success for GSM #2
Decrease in the GSM symptoms on VAS scale 0-10. vaginal dryness, burning, itching, and dyspareunia,dysuria (0: complete absence of symptoms, 10: worst possible symptoms).
Measured: 3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #1
Change in ICIQ-SF score from moderate to mild incontinence, or from mild to nil incontinence.
Improve the quality of life related to incontinence by decreasing the score in the interference with everydays life question.
Measured: 3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #2
Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence.
Measured: 3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #3
Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10
Measured: 3 months and 9 months post laser treatments
Patient Global Impression
Score in the Patient Global Impression of Improvement, as better and much better.
Measured: 3 months and 9 months post laser treatments
Patient Satisfaction
Score in the degree of patient satisfaction, as satisfied and very satisfied.
Measured: 3 months and 9 months post laser treatments
Safety evaluation
Each of the following safety outcome variables recorded across study duration will be assessed
- Pain rating during and after laser treatment.
- Frequence and severity of potential adverse effects.
Measured: 61 days (at each treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 May 2019
- Primary completion15 May 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
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 Vaginal AtrophyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanta System, S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956563
- Sponsor's protocol ID
- YLMT_VAG
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause
- ClinicalTrials.gov ID
- NCT03956563
- Acronym / sponsor ID
- YLMT_VAG
- Conditions
- Vaginal Atrophy, Genitourinary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Quanta System, S.p.A.Industry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 20 May 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.
The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment.
The secondary objectives are:
- Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months.
- Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment.
- To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment
- For the GSM symptoms
- For the urinary symptoms and UI
- To assess the patient's satisfaction with the laser treatment.
- For the GSM symptoms
- For the urinary symptoms and UI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment arm | Active comparator | Device: Youlaser MT Group 1Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment |
| Control arm | Sham comparator | Device: Youlaser MT Group 2Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Menopausal women (defined as ³1 year without menstruation until 65 years of age and no more than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness, burning, itching or dyspareunia ) Atrophic vaginal epithelium measured with the VMV values of 0-49%
- To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
- Women able to understand , accept and signed the Informed Consent.
- Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.
Key exclusion criteria (28 listed)
- VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
- Impossibility of introducing the laser device
- History or other energy-based vaginal therapy within 6 months prior to enrollment.
- Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
- Being on regular and effective topical estrogen therapy within the last 3 months.
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 |
|---|---|---|
| Youlaser MT Group 2Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications. Each patient in the control arm will receive 3 simulated laser treatments every 30 days. A placebo consists in a sham device laser that simulates the acoustic signal even if it does not deliver any laser radiation to the subject. | Device | Control arm |
| Youlaser MT Group 1Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications. Each patient in the active arm will receive 3 laser treatments with the laser: one treatment administration every 30 days. | Device | Active treatment arm |
Primary outcome
Atrophic vaginal epithelium change
Time frame: 3 months and 9 months post laser treatments
The primary efficacy outcome measure in this study is to obtain on the atrophic vaginal epithelium at 3 months after the last laser treatment, values going from absent/low estrogenization (0-49%) to moderate or high estrogenization (50-64%) measured with VMV. The results will be compared between the treatment and the control arm.
8 secondary outcomes
Treatment area success for GSM #1
Time frame: 3 months and 9 months post laser treatments
Treatment area success for GSM #2
Time frame: 3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #1
Time frame: 3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #2
Time frame: 3 months and 9 months post laser treatments
Treatment area success for Urinary incontinence #3
Time frame: 3 months and 9 months post laser treatments
Patient Global Impression
Time frame: 3 months and 9 months post laser treatments
Patient Satisfaction
Time frame: 3 months and 9 months post laser treatments
Safety evaluation
Time frame: 61 days (at each treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youlaser MT Group 2 and Youlaser MT Group 1 in people with Vaginal Atrophy and Genitourinary Disease, run by Quanta System, S.p.A. at 1 site in Spain.
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 28 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: status not confirmed, as of the sponsor's last update on 20 May 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Salinas Peña, MD (+34 34 977 310 300, jrsalinas2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrophic vaginal epithelium change (time frame: 3 months and 9 months post laser treatments). 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 NCT03956563, 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 20 May 2019.