Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
To assess the patient's satisfaction with the laser treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment arm | Active Comparator | Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment |
|
| Control arm | Sham Comparator | Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Youlaser MT Group 2 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months and 9 months post laser treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment area success for GSM #1 | Change to vaginal pH<5 | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Salinas Peña, MD | Contact | +34 34 977 310 300 | jrsalinas2@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrician & Gynecologist Hospital Universitario Sant Joan de Reus | Recruiting | Reus | 43204 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40709601 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Youlaser MT Group 1 | Device | 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. |
|
| 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. | 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. | 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 | 3 months and 9 months post laser treatments |
| Patient Global Impression | Score in the Patient Global Impression of Improvement, as better and much better. | 3 months and 9 months post laser treatments |
| Patient Satisfaction | Score in the degree of patient satisfaction, as satisfied and very satisfied. | 3 months and 9 months post laser treatments |
| Safety evaluation | Each of the following safety outcome variables recorded across study duration will be assessed
| 61 days (at each treatment) |