title: 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.
authors.affiliation: a Department of Obstetrics and Gynecology , University Hospital Pisa.
authors.forename: M
authors.initials: M
authors.lastname: Gambacciani
authors.affiliation: b * Centro Palmer, Reggio Emilia.
authors.forename: M G
authors.initials: MG
authors.lastname: Torelli
authors.affiliation: c Centro Medico Radiologico 3P, Noventa di Piave (VE).
authors.forename: L
authors.initials: L
authors.lastname: Martella
authors.affiliation: d Ospedale Campo di Marte Lucca.
authors.forename: G L
authors.initials: GL
authors.lastname: Bracco
authors.affiliation: e Studio Medico , Novara.
authors.forename: A G
authors.initials: AG
authors.lastname: Casagrande
authors.affiliation: f Poliambulatorio Elysium, Albignasego (Padova).
authors.forename: E
authors.initials: E
authors.lastname: Albertin
authors.affiliation: g Ambulatorio Ginecologico , Bologna.
authors.forename: S
authors.initials: S
authors.lastname: Tabanelli
authors.affiliation: h Studio Medico Fossano (CN).
authors.forename: M
authors.initials: M
authors.lastname: Viglietta
authors.affiliation: i Centro Medico Pignatelli , Lecce.
authors.forename: G
authors.initials: G
authors.lastname: D'Ambrogio
authors.affiliation: j Centro Sofia , Monza.
authors.forename: G
authors.initials: G
authors.lastname: Garone
authors.affiliation: k Department of Obstetrics and Gynecology , Catholic University , Rome , Italy.
authors.forename: M
authors.initials: M
authors.lastname: Cervigni
mesh_terms: D004871:Erbium; D005260:Female; D052776:Female Urogenital Diseases / Q000628:therapy*; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods; D053685:Laser Therapy / Q000379:methods*; D053844:Lasers, Solid-State; D008593:Menopause; D017698:Postmenopause; D013577:Syndrome; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000628:therapy*; D014621:Vagina
chemical_list: D004871:Erbium
keywords: ERBIUM LASER; GENITOURINARY SYNDROME OF MENOPAUSE; MENOPAUSE; STRESS URINARY INCONTINENCE; VAGINAL ATROPHY