Chapter 3.1 30 Other secondary outcomes were patient reported and objective measures that assess the short and long-term (24 months) effect of treatment, its adverse events, the degree of discomfort of the treatment procedure by the patient and the operator reported degree of difficulty, if any, encountered during laser application. Patients were clinically assessed at baseline, treatment and follow-up visits, by an independent and experienced urogynecologist, blinded for the allocated treatment. Anatomical success was assessed by means of the POP-Q System and defined as POP-Q = stage 0 (no prolapse) or stage 1 (leading edge <-1cm).5,52 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 and urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).66 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 treatment was measured by means of a continuous VAS-score (0100mm) 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). Statistics and ethics The primary objective of this study was to show the absence of a clinically relevant different POPDI-6 score in patients treated with laser compared to patients treated with PFE as standard treatment. A non-inferiority analysis was performed for the primary endpoint, adopting an 11-point non-inferiority margin.62 A pooled variance t-test was used for the analysis. Sample size to demonstrate with 80% of power that laser is not inferior to PFE with respect to the 4-month POPDI-6 score resulted in 23 patients per arm. The calculation was performed using sealed envelope, assuming a 11-point non-inferiority margin, equal mean POPDI-6 scores in both treatment arms, and an SD of 13.2.67,68 Superiority analyses were applied for testing differences between treatment arms on secondary outcomes. Changes versus baseline were calculated for POP-Q scores, the PISQ-IR score and UDI6 score. and compared using a linear model. The analysis of PGI was performed using a logistic regression model for ordinal data, or, proportional odds model, its results presented as odds ratio (OR). The score test was then used for testing the proportional odds assumption. Linear mixed models for repeated measurements were used for estimating time evolutions. A random intercept was modelled to deal with data clustering. Normality of model residuals was checked graphically. Continuous variables are reported as mean (Standard deviation (SD)) or median (interquartile ranges (IQR)) for ordinal or skewly distributed variables. Categorical variables are reported as frequencies with percentages. This article follows the CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting parallel group randomised trials.69 This study was executed at the University Hospitals Leuven, Belgium, its protocol was approved by its Ethics Committee on Clinical Research (S64093), and registered at ClinicalTrials.gov (NCT04523298).
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