Last updated on May 2019

Effect of Hybrid Laser 10600+1540 nm on GSM


Brief description of study

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. 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.
  2. 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.
  3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment
    • For the GSM symptoms
    • For the urinary symptoms and UI
  4. To assess the patient's satisfaction with the laser treatment.
    • For the GSM symptoms
    • For the urinary symptoms and UI.

Clinical Study Identifier: NCT03956563

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