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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.
Climacteric. 2015; 18 Suppl 1:43-8.C

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.

Authors+Show Affiliations

a Department of Obstetrics and Gynecology , University Hospital Pisa.b * Centro Palmer, Reggio Emilia.c Centro Medico Radiologico 3P, Noventa di Piave (VE).d Ospedale Campo di Marte Lucca.e Studio Medico , Novara.f Poliambulatorio Elysium, Albignasego (Padova).g Ambulatorio Ginecologico , Bologna.h Studio Medico Fossano (CN).i Centro Medico Pignatelli , Lecce.j Centro Sofia , Monza.k Department of Obstetrics and Gynecology , Catholic University , Rome , Italy.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26366800

Citation

Gambacciani, M, et al. "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." Climacteric : the Journal of the International Menopause Society, vol. 18 Suppl 1, 2015, pp. 43-8.
Gambacciani M, Torelli MG, Martella L, et al. 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. Climacteric. 2015;18 Suppl 1:43-8.
Gambacciani, M., Torelli, M. G., Martella, L., Bracco, G. L., Casagrande, A. G., Albertin, E., Tabanelli, S., Viglietta, M., D'Ambrogio, G., Garone, G., & Cervigni, M. (2015). 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. Climacteric : the Journal of the International Menopause Society, 18 Suppl 1, 43-8. https://doi.org/10.3109/13697137.2015.1071608
Gambacciani M, et al. 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. Climacteric. 2015;18 Suppl 1:43-8. PubMed PMID: 26366800.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Gambacciani,M, AU - Torelli,M G, AU - Martella,L, AU - Bracco,G L, AU - Casagrande,A G, AU - Albertin,E, AU - Tabanelli,S, AU - Viglietta,M, AU - D'Ambrogio,G, AU - Garone,G, AU - Cervigni,M, PY - 2015/9/15/entrez PY - 2015/9/15/pubmed PY - 2016/6/9/medline KW - ERBIUM LASER KW - GENITOURINARY SYNDROME OF MENOPAUSE KW - MENOPAUSE KW - STRESS URINARY INCONTINENCE KW - VAGINAL ATROPHY SP - 43 EP - 8 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 18 Suppl 1 N2 - 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. SN - 1473-0804 UR - https://www.unboundmedicine.com/medline/citation/26366800/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_ L2 - https://www.tandfonline.com/doi/full/10.3109/13697137.2015.1071608 DB - PRIME DP - Unbound Medicine ER -