VELSUI 41 Incontinence severity was categorised by the four-level Sandvik Severity Index Score (SIS).90 Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12). Patients could have concomitant urge incontinence as long it was not the leading factor. Exclusion criteria encompassed insensible loss, any PFMT or vaginal laser therapy 12 months prior to inclusion, previous surgery for urinary incontinence or prolapse, prolapse grade 3 or 4, pregnancy or within 12 months after delivery, vaginal bleeding, injuries or infection in the treated area, or any condition that could interfere with study compliance. The study was executed at a single university centre, its protocol was approved by its Ethics Committee on Clinical Research and was registered at ClinicalTrials.gov. Randomisation and masking After determining eligibility and obtaining written informed consent, participants were randomised (1:1) by the study coordinator, who was not involved in subsequent treatment or clinical assessment. A secure website facilitated randomization using a single block computer-generated list (https://www.sealedenvelope.com/simple-randomiser/v1/trials/velsui-2). Procedures Laser therapy was performed using a 2940 nm vaginal erbium laser (SP Spectro, Fotona, Ljubljana, Slovenia) with SMOOTH mode setting, allowing non-ablative, thermal-only operation. Parameters were set according to the standard manufacturer instructions, which are based on preclinical and clinical studies.55-57 Participants in the laser group received three applications at monthly intervals with an option to request additional treatment courses, up to a maximum of six applications. Treatment was administered by an experienced physician not further involved in the management or follow up of patients, and involved full vaginal canal irradiation (using a 360° circular adapter), additional irradiation of the anterior vaginal wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule (using a straight handpiece). Each application lasted around 15 minutes and was performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia. In our country, standard conservative management consists of a course of nine PFMT sessions supervised one-to-one by a pelvic floor physiotherapist, chosen by the women and general practitioner at their discretion (http://bicap.be). Again, patients could request up to nine additional PFMT courses if they felt the need for this. After assessment of the primary outcome, i.e. 4 months after randomisation, participants could ask for additional or alternative treatments within the current local standard of care. All treatments within this study were free of charge to the patients. Clinical assessments occurred at baseline, treatment and follow-up visits, by an independent and experienced urogynecologist. Study participants self-reported outcomes at baseline and before each treatment visit. Follow-up visits were at 1, 6, 12 and 24 months after the last therapeutic session.
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