Athanasios E Dellis1, Athanasios G Papatsoris2, Francis X Keeley3, Aristotelis Bamias4, Charalambos Deliveliotis2, Andreas A Skolarikos2. 1. 1 Second Department of Surgery, School of Medicine, Aretaieion Hospital, National and Kapodistrian University of Athens , Maroussi, Greece . 2. 2 Second Department of Urology, School of Medicine, Sismanogleion Hospital, National and Kapodistrian University of Athens , Maroussi, Greece . 3. 3 Southmead Hospital, Bristol Urological Institute , Bristol, United Kingdom . 4. 4 Department of Therapeutics, School of Medicine, Alexandra Hospital, National and Kapodistrian University of Athens , Athens, Greece .
Abstract
PURPOSE: To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents. MATERIALS AND METHODS: After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p < 0.05. RESULTS: Patients receiving tamsulosin or solifenacin expressed significantly lower urinary (p < 0.001), pain (p < 0.001 with stent in situ), and general health index (p = 0.002 in first and p < 0.001 in fourth week with stent in situ) scores. Sexual life and quality of work were also positively influenced. Patients on combination therapy expressed lower urinary (p < 0.001) and pain (p < 0.001) scores in the fourth week with stent in situ and work performance in the first week and with stent in situ (p = 0.001) and after stent removal (p = 0.005). No patients had to discontinue medication due to side effects. CONCLUSIONS: Stent-related morbidity is a reality in the majority of patients. Simple medication, such as tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.
RCT Entities:
PURPOSE: To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents. MATERIALS AND METHODS: After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p < 0.05. RESULTS:Patients receiving tamsulosin or solifenacin expressed significantly lower urinary (p < 0.001), pain (p < 0.001 with stent in situ), and general health index (p = 0.002 in first and p < 0.001 in fourth week with stent in situ) scores. Sexual life and quality of work were also positively influenced. Patients on combination therapy expressed lower urinary (p < 0.001) and pain (p < 0.001) scores in the fourth week with stent in situ and work performance in the first week and with stent in situ (p = 0.001) and after stent removal (p = 0.005). No patients had to discontinue medication due to side effects. CONCLUSIONS: Stent-related morbidity is a reality in the majority of patients. Simple medication, such as tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.
Authors: M May; M Schönthaler; C Gilfrich; I Wolff; J Peter; A Miernik; H-M Fritsche; M Burger; M Schostak; S Lebentrau Journal: Urologe A Date: 2018-02 Impact factor: 0.639