Ann-Sophie Page

Chapter 3.2 40 INTRODUCTION The prevalence of stress urinary incontinence (SUI) ranges between 10 and 39% in the general population.77 Although SUI is not a life-threatening condition, its symptoms have a severe impact on the patients’ quality of life and wellbeing. Conservative treatments for women who actively seek help typically include pelvic floor muscle training (PFMT) and pessaries, both requiring a high level of commitment in order to achieve optimal results. Pessaries are less successful on the longer term, mainly due to high discontinuation rates.78 PFMT improves SUI symptoms both on the short (74%) and longer (41-85%) term and is therefore considered to be the first line conservative treatment.79,80 Though surgery by mid-urethral slings is the most effective treatment 81, their use is increasingly being questioned and even banned in some countries, due to graft related complications. Moreover, a study on patient preference has shown that participants are willing to accept a slightly lower probability of cure to avoid substantial postoperative pain and possible complications by receiving a less invasive treatment.36 This has created a clinical need for non-surgical alternatives for treating SUI. Vaginal laser application is appealing as, if proven effective, this is a minimally invasive treatment with minimal morbidity. However, the safety and efficacy of laser treatment has not yet been confirmed, as highlighted by the US Food and Drug Administration, the European board and College of Obstetrics and Gynaecology (EBCOG) and other authorities.46,47,49 In its recent 2024-position statement, EBCOG again urgently called for good quality research with appropriate patient reported outcome measures and long-term follow-up data for vaginal laser therapy.49 Indeed, although multiple studies investigated the use of Erbium : Yttrium Aluminium Gadolinium (Er:YAG) laser for the management of SUI, they report conflicting results, and many studies lack comparison to another conservative treatment.82-88 Therefore, the purpose of this study was to evaluate the efficacy and safety of vaginal Er:YAG laser application for mild to moderate SUI, as compared to PFMT, and this over a two year followup period. MATERIALS AND METHODS Study design and participants This is a single centre, randomised controlled clinical trial on the efficacy of Er:YAG laser application in reducing SUI. The comparator was PFMT and the target group comprised women with mild to moderate SUI expressing a desire for treatment. Diagnostic criteria to identify SUI in participants were according to established guidelines and included history and clinical examination.89

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