PURPOSE: We validated the Italian version of the Ureteral Stent Symptoms Questionnaire in male and female patients with an indwelling ureteral stent. MATERIALS AND METHODS: A double-back translation of the original Ureteral Stent Symptoms Questionnaire was performed by 3 urologists and 4 professional translators. A total of 78 patients (cases) with and 35 healthy subjects without (controls) an indwelling ureteral stent were asked to complete the Italian version of the Ureteral Stent Symptoms Questionnaire and a visual analog scale for pain as well as the International Prostate Symptom Score (men) and Urogenital Distress Inventory-6 plus Incontinence Impact Questionnaire-7 (women). Cases were evaluated at weeks 1 and 4 after stent placement, and at week 4 after removal, while controls were evaluated once. The psychometric properties of the questionnaire were analyzed. RESULTS: A total of 66 cases and 30 controls were suitable for analysis. The questionnaire showed good internal consistency in all domains except global quality of life compared with that of the International Prostate Symptom Score (Cronbach's alpha >0.75). Test-retest reliability was good except for the sexual matters domain (Pearson's coefficient >0.7). Relatively high correlation coefficients (greater than 0.65) were found for the visual analog scale for pain, the International Prostate Symptom Score, the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 with the corresponding Ureteral Stent Symptoms Questionnaire domains, suggesting good convergent validity. Sensitivity to change and discriminant validity were also good (p <0.001). CONCLUSIONS: The Italian version of the Ureteral Stent Symptoms Questionnaire is a reliable and robust instrument that can be self-administered to male and female Italian patients with an indwelling ureteral stent in the clinical and research settings.
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