VELPOP 29 vaginal bleeding, injuries or infection in the treated area, or conditions that could affect study compliance. Following assessment of eligibility criteria and written informed consent, participants were randomised (1:1) by the study coordinator, who was not further involved in the treatment nor clinical assessment of study participants via a secure website using a single block computergenerated list (https://www.sealedenvelope.com/simple-randomiser/v1/trials/velpop-2). Procedures Laser was applied using a 2940 nm vaginal erbium laser (SP Spectro, Fotona, Ljubljana, Slovenia) with SMOOTH mode setting, allowing for non-ablative, thermal-only operation.54 The parameters were the standard settings defined by the manufacturer, based on preclinical and clinical studies.55-57 We used the erbium laser rather than the CO2-laser to enable comparison with other trials on prolapse, which all reported on the erbium laser.57-59 Participants in the laser group received three applications at monthly intervals with the option to request additional treatment courses, up to a maximum of six applications. Laser treatment was performed by an independent physician experienced with vaginal laser application. An application consisted of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed vaginal wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area (using a straight handpiece). In Belgium, the standard conservative management consists of a course of nine PFE sessions supervised one-to-one by a pelvic floor physiotherapist, chosen by the women at their discretion (http://www.bicap.be). Again, patients could request nine additional PFE courses if they felt the need for this. Crossover was permitted four months after the first treatment. Patients were clinically assessed at baseline, treatment and followup visits, by an independent and experienced urogynecologist. Study participants self-reported outcomes at baseline and prior to each treatment visit. Follow-up visits were scheduled at 1, 6, 12 and 24 months after the last therapeutic session. Outcomes Primary outcome was subjective improvement of POP symptoms, measured through the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) as suggested by the International Consultation on Incontinence (ICI) guideline, comparing scores at baseline to those four months after first treatment.60,61 Participants answered to six questions on POP-symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The total score (range:0-100) was obtained by multiplying the mean value of all items by 25 with Higher scores indicate more distress. A mean difference of 11 points in the POPDI-6 has been reported as a clinically relevant difference between groups.62 Secondary, subjective success defined as a reduction of at least 25% compared to baseline was measured.63
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