Effect of Hybrid Laser 10600+1540 nm on GSM

Status Recruiting

Clinical 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. 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 Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03956563
Study type	Interventional
Source	Quanta System, S.p.A.
Contact	Juan Salinas Peña, MD
Phone	+34 34 977 310 300
Email	jrsalinas2@gmail.com
Status	Recruiting
Phase	N/A
Start date	May 15, 2019
Completion date	August 15, 2020

View Details

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