Ann-Sophie Page

VELSUI 47 findings.83-88 All but one of these studies87 were incorporated in a meta-analysis on 577 patients, reporting “no efficacy of energy-based therapy over placebo intervention for the management of SUI, either in terms of subjective or objective outcomes”.95 This review considered both CO2 and Erbium laser as well as radiofrequency energy treatments, however meta-analysis was not performed for patients treated with Er:YAG laser or radiofrequency due to the low number of trials. Our findings seem to confirm a measurable treatment effect, which was observed in another two yet placebocontrolled RCTs where Er:YAG laser was used for SUI.83,87 However, the heterogeneity in study design, patient population, treatment protocols and outcomes measured in those two and our study, necessitates caution when generalizing the findings. All studies confirm the safety of laser treatment, which is in line with previously published data 50,76,96. Our study has several strengths. First, it is a randomised controlled trial, with concealed allocation of participants, pre-determined sample size, focusing on patient-reported outcomes and using independent assessment of objective outcomes and reporting long term follow up. Validated methods of outcome assessment according to the International Continence Society (ICS) / International Urogynecological Association (IUGA) guidelines were used, and all outcomes were recorded at each treatment and follow-up visit, minimizing the risk of recall bias.89,97 We also acknowledge some limitations: there was a greater than expected study discontinuation, possibly due to the high number of visits and long follow up period required from patients, although not compromising the power of this study. One could also argue that the non-inferiority design is a limitation, given the typically higher costs of laser therapy compared to PFMT. However, based on the available evidence, we did not expect superiority of laser.51 Conversely, our aim was to evaluate whether laser could be an alternative non-surgical treatment option for women with bothersome SUI. Therefore, we did not exclude women with a negative CST at baseline (laser: 1/30, PFMT 5/30). The effect of doing so, if any, would be compensated for by randomization. In addition, there is robust evidence that for the diagnosis of genuine SUI, the sensitivity of CST is only 57%.93 Our findings demonstrate lower success rates of PFMT as compared to previously published data.14,79 However, this was a “real world” trial, where the comparator (PFMT) was recorded in the clinical context of our patients. To ensure all participants received a proper PFMT program, they were referred only to physiotherapists who had completed a specialized training program and were accredited members of their professional organization “BICAP” (http://bicap.be). We did on purpose not interfere with the individual treatments as these BICAP accredited physiotherapists are the best specialist treatment available to patients in our health system. Unfortunately, data on training program details and characteristics, were not measured. Finally, the number of patients remains small with limited diversity, which may underestimate the occurrence of uncommon but potentially clinically relevant adverse events or the wider applicability of our findings.

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