Ann-Sophie Page

Chapter 3.1 34 DISCUSSION In women with symptomatic stage 2 and 3 anterior and/or posterior wall prolapse, the treatment response four months from baseline to vaginal laser was comparable to that to PFE. Although initially the majority of women were at least satisfied, 24 months after the last treatment, more than half of patients sought additional, yet alternative, treatments. This study has several strengths, including its design. It was an assessor-blinded RCT with concealed allocation of participants and pre-determined sample size, and used relevant patientreported outcomes. To our knowledge, this is the first RCT logically comparing laser therapy to another standard conservative therapy that patients can choose. It has a meaningful longer term follow-up period to evaluate the durability and safety of both treatments. Secondly, validated methods of outcomes assessment according to the International Continence Society (ICS)/ International Urogynecological Association (IUGA) guidelines were used. We also recorded all outcomes at each treatment and follow-up visit, minimizing the risk of recall bias. Thirdly, inclusion and exclusion criteria were clearly defined. For instance, previous studies57-59 did not state whether previous vaginal surgery patients were excluded: the role of laser in scarred or fibrosed tissue compared to intact tissue may impact its efficacy. Finally, there were no missing data for the primary outcome, and results were interpreted on an intention-to-treat basis. We acknowledge some weaknesses. Laser was not compared to sham application, so we cannot rule out placebo effects of laser, which have been reported.70-72 We opted to compare to PFE, as this is the standard of conservative care in our setting. PFE were not standardized but offered within the clinical “real life” setting, consisting of pelvic floor muscle training supervised by an experienced physiotherapist.14 One could also argue the non-inferiority design given the typically higher costs of laser therapy compared to PFE. However, based on the available evidence, we did not expect superiority of laser.58 The clinical aim of our study was therefore to evaluate whether laser could be a worthy alternative non-surgical treatment for women with bothersome POP symptoms. Another limitation is the we only treated Caucasian women, who constitute the vast majority in our clinic. Finally, although adequately powered, the number of patients remains small, which may underestimate the occurrence of uncommon adverse events. At first glance, these results contrast with those of Athanasiou et al, who randomised women with symptomatic stage 2 or 3 prolapse between Er:YAG laser and watchful waiting. They did not report any objective nor subjective improvement over a four month period in either group.58 They concluded therefore that laser was not a treatment option in symptomatic POP-patients. In that study however, only menopausal women, who failed earlier conservative therapy, and were already scheduled for surgery, were included. Conversely, our study population were patients with bothersome POP seeking conservative treatment. Moreover, we excluded patients who had undergone PFE or vaginal laser therapy 12 months before enrollment. It is plausible that the patient profile and their expectations played a role in the perceived efficacy of conservative therapy.73,74 Another difference

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