Review Article David Elia, Marco Gambiacciani, Jean-Marc Ayoubi, Nicolas Berreni, Jean Marc Bohbot, Philippe Descamps, Rene Druckmann, Hugues Geoffrion, François Haab, Niko Heiss*, Nicolas Rygaloff and Eleonora Russo Female urine incontinence: vaginal erbium laser (VEL) effectiveness and safety https://doi.org/10.1515/hmbci-2020-0012 Received February 13, 2020; accepted May 6, 2020; published online October 29, 2020 Abstract: Urinary incontinence is a common health prob- lem that impacts the quality of life of women at different ages. Its physiopathology is not unequivocal, and it is necessary to consider the stress urinary incontinence (SUI), the overactive bladder syndrome and the mixed inconti- nence (MUI). According to the type of incontinence, its impact on the quality of life and age of the patients, ther- apeutic strategies are currently summarized in physio- therapy, surgery and drug treatments. We already know the benefit/risk ratio of each of these strategies. Our objective is to evaluate the potential effectiveness and safety of the VEL, an innovative vaginal laser technique (VEL – Vaginal Erbium Laser, erbium yttrium-aluminum- garnet -Er: YAG) a non-invasive laser proposed as a treat- ment for SUI, overactive bladder syndrome and MUI. The mechanisms of action of lasers are discussed in general and those of VEL in particular with the description of the Smooth® mode. To do this, we have collected the 21 pub- lished studies including the first randomized vs. placebo and two pilot studies of intra-urethral VEL. In conclusion: VEL procedures already have their place between the rehabilitation of the perineal floor and surgery. Further properly sized, randomized studies are needed to evaluate the laser treatments in comparison with other therapies, as well as to assess the duration of the therapeutic effects and the safety of repeated applications. Keywords: FDA warning; intraurethral ErYAG smooth; laser ErYAG smooth; non-ablative laser; overactive bladder syndrome; stress urinary incontinence; tension-free vaginal tape; transobturator tape. I. Overactive bladder syndrome (OAB) is mainly char- acterized by a urinary urgency complaint often accompanied by frequent urination, nocturia and oc- casional urinary incontinence [9, 10]. The overactive bladder is either neurogenic (neurological conditions) or non-neurogenic, the main causes of which are aging and pelvic prolapse [11]. Drug treatments are the main modalities used to treat this syndrome. There are two types of molecules: – anticholinergics [11] – β3-adrenergic receptor agonists [12]. However, these molecules exhibit a number of side effects [13, 14]. As for β3-adrenergic receptor agonists, they may be contraindicated in patients with severe uncontrolled hypertension as they can worsen it [12]. II. Stress urinary incontinence (SUI) is defined as urinary leakage caused by increased abdominal pressure for example such as coughing [1]. These leaks are the result of the alteration of the support structures of the bladder and urethra. This condition affects up to 49% of women. Current treatments for SUI include either non-invasive treatment or surgery if the first fails. Although pelvic floor rehabilitation therapy may work very well, many patients experience poor outcomes due to bad persistence and inadequate practice [3, 4]. Among the various surgical techniques effective in the treatment of SUI, the procedure for placing a prolene urethral strip is effective [1]. The tension-free vaginal band (TVT) allows replacement of defective support structures by supporting the bladder neck and urethra with synthetic material [5–7]. Today, a TVT or a trans- obturator band (TOT) is generally used [1]. These pro- cedures have worked. However, in the long term, a risk of complications may arise due to the synthetic nature *Corresponding author: Niko Heiss, Vaginal Erbium Laser Academy France, Elsan, Polyclinique Kenval, Nîmes, France, E-mail: docteur.heiss@orange.fr David Elia, Jean-Marc Ayoubi, Nicolas Berreni, Jean Marc Bohbot, Philippe Descamps, Rene Druckmann, Hugues Geoffrion, François Haab and Nicolas Rygaloff, Vaginal Erbium Laser Academy France, Paris, France Marco Gambiacciani and Eleonora Russo, Vaginal Erbium Laser Academy Italia, Livorno, Italy Horm Mol Biol Clin Invest 2020; ▪▪▪(▪▪▪): 20200012