Chapter 3.2 42 Outcomes The primary outcome was the self-reported cure or improvement of SUI symptoms, measured through the validated Urogenital Distress Inventory (UDI-6), comparing the score at baseline to the score four months after the first treatment.66 In this score, cure is defined as answering “No” (0) to the question “Do you experience urine leakage related to physical activity, coughing or sneezing?”. Converted UDI-6 scores range from 0 to 300, with a defined minimum important difference (MID) of 11.91,92 Secondary outcomes included adverse events and patient reported and objective measures to measure the short and long-term (24 months) treatment effects. Objective success was assessed by means of the International Continence Society (ICS) uniform cough stress test (ICS-UCST) by an independent assessor.93 The patient was first asked to cough forcefully 1-4 times in supine/lithotomy position with 200-400ml of fluid in the bladder (assessed by bladder scan). In case the examiner did not visualize leakage from the urethral meatus, the test was repeated in upright position. Patient satisfaction was measured by means of the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better).64 Sexual function was assessed by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR).65 The longevity of the effect was measured by the need for, and the timing for repeating the same, or initiating an alternative therapy. Patient-reported discomfort of the laser procedure was measured using a continuous VAS-score (0-100 mm, with 0 presenting no discomfort and 100 the worst possible discomfort) and the degree of difficulty encountered by the operator by means of a 5-point Likert scale (1=very difficult, 2=difficult, 3=neutral, 4=easy, 5=very easy). Adherence to PFMT was measured by recording if the women had completed their PFMT sessions as prescribed or, conversely, had discontinued the sessions prematurely, either because of success, or if applicable, another reason. Statistical analysis The primary objective was to demonstrate the absence of a clinically relevant lower UDI-6 score in patients treated with laser compared to patients treated with PFMT as the standard treatment. A non-inferiority analysis was performed for the primary endpoint adopting a 11-point non-inferiority margin. The analysis involved estimating the 95% confidence interval around the difference in means between laser and PFMT-treatment groups. Non-inferiority was demonstrated if the upper limit was lower than the non-inferiority margin of 11. A linear model was used for data analysis, correcting for baseline UDI-6 score. A sample size calculation for a non-inferiority analysis, to show that laser is
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