In the last decade there has been an ever growing user demand for minimally invasive vaginal procedures, and some of the most perspective and promising actors in the field have been energy-based devices (EBD), such as lasers (Er:YAG and CO2) and radiofrequency (RF). 
The aim of this study was to acquire information about the use of non-ablative, thermal-only Er:YAG laser for particular (uro)gynaecology indications: stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), vaginal laxity and pelvic organ prolapse(POP); as well as to obtain information on adverse effects (AE) observed with the use of this device in clinical practice.

Study was designed as a global survey to be conducted among the users of non-ablative Er:YAG laser. It included a simple request to provide the number of patients that were treated and the number of laser-related AEs observed in their practice during a specified (active) period from 2012–2019. The survey was prepared in an electronic table form. Several metrics were followed and calculated: total number of respondents, global distribution of respondents, total number of treated patients for particular gynaecology indication, global patient population structure, list and frequency of observed AEs.

This survey was conducted in a period from August 2018 to April 2019. In this period a response from 535 users from 43 different countries was collected (Table 1). The respondents reported about 113,174 patients being treated in a period from 2012 to 2019. Among the 535 respondents, 188 (35%) provided quantitative data on the frequency of AEs observed when treating 43,095 patients (representing 38% of patients gathered by this survey). 160 respondents (30%) provided information about patient population structure. 62,727 patients from these sites represent 55 % of all patients gathered by this survey. According to their data 46% of the patients received treatment for vaginal laxity, 31% were patients with SUI, 9% suffered from GSM, 7% had POP, while 7% of the patients had concurrent symptoms of vaginal laxity and SUI. 
When comparing the frequencies of AEs collected by this survey (Table 2) with the frequencies of AEs reported in the published studies where non-ablative, thermal only Er:YAG laser was used for the same indications (pooled data of 19 trials with a total of 1570 patients (from manufacturer’s data on file), a high consistency of the results is observed. For example, the calculated overall frequency from previously reported data on increased vaginal discharge is 3.6% (range: 0–88%) compared to 4.0% observed in this survey, whereas the frequency of burns is 0.06% (range: 0–0.2%), compared to 0.16% from this survey, pinpoint bleeding was observed with a frequency of 0.2% (range: 0–4.0%) compared to 1.16% reported in this survey, and pigmentary changes were observed with a frequency of 0.2% (range: 0–12%), compared to 0.02% in this survey.

In our opinion, the significant period of time (eight years) of active non-ablative, thermal-only Er:YAG laser use in clinical practice and the number of women included in the survey being the largest ever reported in this field, make this survey a relevant resource on non-ablative, thermal-only Er:YAG laser safety. AEs are mild and transient and the frequencies of their occurrence are low. The majority of the AEs have already been observed and reported in published research papers that described the use of non-ablative, thermal only Er:YAG laser in gynaecology (1–3). They have been recognized by the manufacturer and have been regularly evaluated. Reported frequencies of the AEs vary from respondent to respondent, which may be a result of several factors; firstly, some of the observed AEs, as in the case of oedema and vaginal discharge, are not considered problematic in terms of severity, and not even considered as an AE by all practitioners. Oedema is more commonly regarded as an indicator of the thermal effect of the non-ablative, thermal only Er:YAG laser application, and is therefore considered an anticipated treatment response. Vaginal discharge, described as watery, is an indicator of oedema resolution. Furthermore, assessment of AEs depends on the organizational setup and follow-up routine of each clinical practice. An important factor that needs to be considered is the patients’ informed consent process; if the process is adequate, the patients are informed about possible AEs that may occur, are able to make self-assessment after the procedure and consider whether a particular AE is worth reporting.

Our global survey supports initial conclusions of the published data that minimally invasive thermal-only intravaginal laser treatment with non-ablative ErYAG laser has intrinsically very low risk profile (1–3). The observed AEs are mild and transient and the frequencies of their occurrence are low.

Blaganje M, Šcepanovic D, Žgur L, Verdenik I, Pajk F, Lukanovic A. Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2018;224:153–8.
Kuszka A, Gamper M, Walser C, Kociszewski J, Viereck V. Erbium:YAG laser treatment of female stress urinary incontinence: midterm data. Int Urogynecol J. 2019 Dec
Gambacciani M, Levancini M, Russo E, Vacca L, Simoncini T, Cervigni M. Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause. Climacteric. 2018 Apr;21(2):148–52.