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Background: Energy-based devices are becoming a popular option for minimally invasive vaginal procedures. The aim of this study was to obtain information on the frequency of occurrence of adverse effects (AEs) related to vaginal erbium laser (VEL™) treatment.Materials and methods: The global survey was conducted among practitioners using the non-ablative VEL™ (Fotona, Ljubljana, Slovenia). Users were invited to provide the number of patients treated with VEL™ and the number of observed laser-related AEs.Results: The survey was conducted from August 2018 to April 2019. Responses from 535 practitioners were collected, with a total of 113,174 patients treated in the period from 2012 to 2019. Out of 535 respondents, 160 (30%) shared detailed information about the indications they treated in a population of 62,727 patients, whereas 188 (35%) respondents provided information on the frequency of AEs observed in their treated population of 43,095 patients. All observed AEs were mild to moderate, transient and appeared with low frequencies.Conclusions: Minimally invasive thermal-only laser treatment using the non-ablative VEL™ procedures appears to be safe and the incidence of AEs is low. [ABSTRACT FROM AUTHOR]

Aims. To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies. Methods. A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time. Results. A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment (p<0.0001 for reduction over time). The effect was associated with a reduction in severity of patients' symptoms evaluated with the O'Leary-Sant questionnaire (p=0.0110 and p=0.0014 for cystitis symptoms and problem mean scores, respectively) and the PUF scale (p=0.0163 and p=0.0005 for symptom and bother mean scores, respectively). m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary (p=0.0005) and a small but not significant improvement of bladder capacity. Conclusions. These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products. [ABSTRACT FROM AUTHOR]

Urinary incontinence (UI) is more common than any other chronic disease, such as hypertension, depression or diabetes, with the prevalence estimated between 9 and 74%. Among the various forms of urinary incontinence, stress incontinence (SUI) is the most prevalent (50%), with urgency incontinence (UUI) representing 11% and mixed type (MUI) 36% (3% not classified). Nowadays, the restoration of urinary continence is one of the greatest challenges for the well-being and quality of life of women. The introduction of minimally invasive surgical procedures changed the anti-incontinence surgery, leading to similar, or even better results as traditional, invasive techniques. The development of the mid-urethral slings offers a viable alternative to surgical correction of SUI. These further developments of mini-sling procedures are appropriate for local anesthesia, less traumatic, ‘tension-free’ (to ensure continence without obstruction), simple, rapid and repeatable. The latest minimally invasive approaches can be performed in day surgery, with clear advantages compared to traditional procedures. A novel approach through the use of vaginal laser techniques could represent an additional opportunity, as a non-invasive, outpatient method to treat SUI. [ABSTRACT FROM PUBLISHER]

Introduction and hypothesis: Reconstruction of the glycosaminoglycan layer plays a role in the successful treatment of bladder pain syndrome/interstitial cystitis (BPS/IC). Intravesical instillations of hyaluronic acid (HA) and chondroitin sulphate (CS) have given results in the short term. We hypothesise that these benefits continue in the longer term. Methods: With the aim of evaluating this therapy over a longer period we treated 12 BPS/IC patients refractory to other treatments with a combination of HA 1.6 % and CS 2.0 % over a period of 3 years assessing symptoms and quality of life using a visual analogue scale, 3-day voiding diaries and validated questionnaires. Results: Improvements in bladder function were sustained for 3 years (mean number of daily voids decreased from 17.8 at baseline to 15.5 at 9 months and 11.9 at 3 years, and mean volume per void from 136.8 ml at baseline to 143.9 ml at 9 months and 180.9 ml at 3 years). Quality of life assessments confirmed these improvements. Conclusions: Intravesical instillations of HA and CS produced a sustained improvement of the symptomatology, up to 3 years, in patients with BPS/IC refractory to previous treatments. Further confirmation would be expected from larger controlled trials. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various reports within the issue on topics including the scientific evidence on vaginal erbium laser, the effect of menopause on the lower urogenital tract, and the quality of life of women with stress urinary incontinence.

Aim To evaluate the effects of the vaginal erbium laser (VEL) in the treatment of postmenopausal women suffering from genitourinary syndrome of menopause (GSM). Method GSM was assessed in postmenopausal women before and after VEL (one treatment every 30 days, for 3 months; n = 45); the results were compared with the effects of a standard treatment for GSM (1 g of vaginal gel containing 50 μg of estriol, twice weekly for 3 months; n = 25). GSM was evaluated with subjective (visual analog scale, VAS) and objective (Vaginal Health Index Score, VHIS) measures. In addition, in 19 of these postmenopausal women suffering from stress urinary incontinence (SUI), the degree of incontinence was evaluated with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after VEL treatments. Results VEL treatment induced a significant decrease of VAS of both vaginal dryness and dyspareunia (p < 0.01), with a significant (p < 0.01) increase of VHIS. In postmenopausal women suffering from mild to moderate SUI, VEL treatment was associated with a significant (p < 0.01) improvement of ICIQ-SF scores. The effects were rapid and long lasting, up to the 24th week of the observation period. VEL was well tolerated with less than 3% of patients discontinuing treatment due to adverse events. Conclusion This pilot study demonstrates that VEL induces a significant improvement of GSM, including vaginal dryness, dyspareunia and mild to moderate SUI. Further studies are needed to explore the role of laser treatments in the management of GSM. [ABSTRACT FROM AUTHOR]

The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH®) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth®, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (n = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Individual FSFI domain scores (n = 569) significantly (p < 0.001) increased after VEL-SMOOTH® treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH® treatment may improve sexual function in postmenopausal women suffering from GSM. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the long-term efficacy of a second generation of vaginal laser treatment, the vaginal erbium laser, as a non-ablative photothermal therapy for the management of genitourinary syndrome of menopause.Methods: The study was performed using an erbium laser crystal yttrium-aluminum-garnet (XS Fotona Smooth™, Fotona, Ljubljana, Slovenia) with a wavelength of 2940 nm. Postmenopausal women (n = 205) were treated with three laser applications at 30-day intervals. Symptoms were assessed before and after treatment throughout 24 months, using the subjective visual analog scale (VAS) and the objective vaginal health index score (VHIS). In addition, postmenopausal women suffering from stress urinary incontinence were evaluated with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).Results: Vaginal erbium laser treatment induced a significant (p < 0.01) decrease in VAS for both vaginal dryness and dyspareunia, as well an increase in VHIS (p < 0.01) up to the 12th month after the last laser treatment. The values returned to levels similar to the baseline after 18 and 24 months. In addition, vaginal erbium laser treatment improved mild-moderate stress urinary incontinence in 114 postmenopausal women. Less than 3% of patients discontinued treatment due to adverse events.Conclusions: These results suggest that vaginal erbium laser may be effective and safe for the treatment of genitourinary syndrome of menopause. [ABSTRACT FROM AUTHOR]

Objective: Primary objective of this study was to assess the effects of trocar-guided transvaginal mesh surgery (TVM) on cure and prevention rates for incontinence, without concomitant surgery for Stress Urinary Incontinence (SUI). Our secondary objectives were anatomical outcomes, relief of symptoms and effect on quality of life (QoL).Study Design: This prospective observational study evaluated women who underwent TVM for symptomatic stage >2 Pelvic Organ Prolapse (POP). SUI was evaluated objectively using the cough stress test with prolapse reduced. SUI and urge urinary incontinence (UUI) were subjectively evaluated using ICIQ-SF. Anatomical cure was defined as stage <2 at POP-Q.Statistical Analysis: McNemar chi-square test; paired t-test; Mann-Whitney test.Results: Seventy-two patients reached final evaluation (mean follow-up 72 months). In the 40 pre-op continent patients, 34 (85%) remained continent postoperatively and 6 (15%) showed de novo SUI. Only 1 patient chose to undergo subsequent TVT. The number needed to treat was 6 to prevent 1 women developing de novo objective SUI and 39 to prevent 1 woman having to undergo SUI surgery. In the 32 pre-op incontinent patients, 18 (56.3%) became continent postoperatively. Only 1 patient chose to undergo subsequent TVT. UUI was present in 44 patients pre-operatively and 15 (20.8%) post-operatively (1 de novo). Forty-four patients (61.1%) were continent post-operatively for SUI and UUI. We observed a significant improvement in storage, voiding, post-micturition and prolapse-related symptoms. The anatomical cure rate was 87.5% for the anterior compartment and 90.3%.for the apical segment. The apical recurrence was 8.3% in the patients previously hysterectomised, 18.8% in the patients with uterus preservation and 0% in the patients with concomitant hysterectomy. QoL scores improved in all domains except sleep and personal relationships. We observed mesh exposure in 10 patients (13.9%), in 5 of whom it was associated with a concomitant hysterectomy CONCLUSIONS: TVM showed excellent results in terms of continence and can be performed without contemporary anti-incontinence surgery, for both continent and incontinent women. Patients should have pre-operative counselling before POP surgery. For severe uterine prolapse the Perigee™ System should be employed with concomitant hysterectomy because uterus preservation is associated with significantly higher apical recurrence rates. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM PUBLISHER]