Ann-Sophie Page

Chapter 3.1 28 INTRODUCTION Pelvic organ prolapse (POP) affects 1-65% of women and its symptoms have a severe impact on their quality of life and wellbeing.39 Treatment options typically include watchful waiting, vaginal pessary use, pelvic floor exercises (PFE) and surgery. Both PFE and pessaries are cheap and safe options, but their use is limited by moderate improvement in symptoms or, in case of pessary use, high discontinuation rates due to side effects.40-42 Surgery has overall good to very good long-term anatomical and subjective cure rates, but comes with an increased risk for complications.43-45 Surgical management of POP also faced increased scrutiny due to concerns over the use of mesh, leading women to be hesitant about undergoing surgery. This has created a renewed interest for non-surgical alternatives for treating POP. Vaginal laser application seems appealing, as, if proven effective, this is a minimally invasive treatment with minimal morbidity. However, the safety and efficacy of laser treatment for the management of numerous indications, including genitourinary syndrome of menopause (GSM), stress urinary incontinence (SUI) and prolapse has not yet been confirmed, as highlighted by the US Food and Drug Administration and other authorities46-48. This includes the European Board and College of Obstetrics and Gynaecology (EBCOG) who called for good quality research with appropriate patient reported outcome measures and long-term follow-up in its 2024-position statement.49 Both for GSM and SUI, the use of laser remains controversial, due to contradictory findings in available randomised trials.49,50 Conversely, for prolapse, there is less robust data. A recent systematic review suggested short-term beneficial effects of laser yet the quality of included studies was judged to be subpar in terms of study design and short follow-up.51 Therefore, the purpose of this study was to evaluate the efficacy and safety of vaginal application of Erbium:Yttrium Aluminium Gadolinium (Er:YAG) laser application for symptomatic stage 2-3 anterior and/or posterior vaginal wall prolapse, as compared to PFE over a two-year follow-up period. MATERIALS AND METHODS Study design and participants This is a single-center, randomised controlled trial on the efficacy of vaginal Er:YAG laser application in reducing prolapse symptoms as compared to PFE. The study took place at a tertiary center in Belgium and the target group were women with bothersome POP symptoms with midvaginal (level II defects, i.e. either anterior and/or posterior wall prolapse) moderate (stage 2 and 3) prolapse according to the Pelvic Organ Prolapse Quantification System (POP-Q).52,53 Exclusion criteria included symptoms or anatomical evidence of intussusception or rectal prolapse or descent of the uterus, cervix or vault (C>Ba/Bp), stage 4 prolapse, any previous PFE or vaginal laser therapy 12 months prior to inclusion, previous POP surgery, pregnancy or within 12 months after delivery,

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