Rationale and design for the Vaginal Erbium Laser Academy Study (VELAS): an international multicenter observational study on genitourinary syndrome of menopause and stress urinary incontinence

ABSTRACT

The genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common clinical challenges for women’s health and quality of life. The laser treatment and particularly the vaginal erbium laser (VEL) may provide a new non-invasive treatment for both GSM and SUI. However, the estimation of the ultimate results of different laser treatments may be altered by different issues, such as patient selection, concomitant treatments, and long-term effect of vaginal laser thermotherapy. In the present paper, we present the protocol for a large multicenter study on the evaluation of the efficacy and safety of VEL for the treatment of GSM and SUI, the Vaginal Erbium Laser Academy Study (VELAS). This study will evaluate the effects of three laser applications in 1500 postmenopausal women. Subjective and objective symptoms will be evaluated prior to the first laser treatment with follow-up visits after 4 weeks from the last laser application, and subsequently after every 3 months for 1 year. Findings from the VELAS have the potential to affect clinical care practice and health decisions for millions of women world-wide for a non-hormonal treatment for GSM and a non-invasive treatment of SUI.

Key words::

• ERBIUM LASER
• MENOPAUSE
• GENITOURINARY SYNDROME OF MENOPAUSE
• VAGINAL ATROPHY
• STRESS URINARY INCONTINENCE

ACKNOWLEDGEMENTS

The authors express their thanks to the Members of the National Independent Advisory Board: Professor Nicoletta Biglia, Torino; Professor Rossella Nappi, Pavia; Professor Anna Maria Paoletti, Cagliari, for their excellent work in revising the protocol.

Conflict of interest The authors report no conflict of interest. The authors alone are responsible for the content and writing of this paper.

Source of funding The authors wish to thank Fotona, Slovenia, and Santec, Italy, for the unrestricted support for the study.