RESUMO
Objective: To validate an Arabic version of the Danish Prostatic Symptom Score (DAN-PSS), a self-administered quality-of-life questionnaire. Patients and methods: The reliability of the Arabic DAN-PSS was assessed by determining the internal consistency (Cronbach's α coefficient) and by assessing the test-retest reliability (Kappa [κ] test). Inter-domain associations were examined using Spearman's correlation coefficient (r). The discrimination validity was evaluated using receiver operating characteristic (ROC) curves. The sensitivity to change of the questionnaire and its individual items was assessed before and after intervention using a paired t-test. Results: In all, 106 men (55 patients with BPH and 51 without BPH symptoms) were included. A high level of internal consistency amongst the three domains of the answered Arabic DAN-PSS questionnaire was observed (Cronbach's α > 0.70). Also, there was a good correlation between storage and voiding (r = 0.75; P < 0.001) and post-micturition symptoms domains (r = 0.51; P < 0.001). Voiding and post-micturition symptoms domains also had a good correlation (r = 0.51; P < 0.001). The agreement between the test and retest scores had a κ value of 0.83 (P < 0.001). The ROC curve had an area under the curve of 0.98. The sensitivity to change comparing patients with BPH who received medical or surgical intervention revealed Arabic DAN-PSS mean (SD) scores of 34.7 (17.7) and 17 (8.7) before and after the intervention, respectively (P < 0.001). Conclusion: The Arabic DAN-PSS is a clear questionnaire, valid, reliable, and responsive that can be used for BPH associated with lower urinary tract symptoms assessment and follow-up in clinical practice and research in Arabic-speaking patients. Abbreviations: AUC: area under the curve; BPH: benign prostatic hyperplasia; CI: confidence interval; DAN-PSS: Danish Prostatic Symptom Score; DRE: digital rectal examination; ICIQ-MLUTS: International Consultation on Incontinence Male LUTS Questionnaire; ICS: international continence society; IPSS: international Prostatic Symptom Score; IPSS-Arb: Arabic version of the IPSS; LUTS: lower urinary tract symptoms; PSA: prostatic specific antigen; PSS: prostatic symptom score; QoL: quality of life; ROC: receiver operating characteristic; UTI: urinary tract infection.
RESUMO
PURPOSE: We assessed the effect of mebeverine in the enhancement of the orthotopic bladder substitute continence. MATERIALS AND METHODS: A randomized trial was carried out for incontinent adult male patients during the first year post-orthotopic bladder substitute surgery. Patients were allocated to receive mebeverine 135 mg or placebo 3 times a day for only 3 months. The primary outcome was to compare the continence improvement between groups, assessed by the urinary domain of the Bladder Cancer Index and sanitary pad use. The secondary outcomes were to assess the safety of the drugs used. RESULTS: In placebo group 47 and in mebeverine group 52 patients completed followup. The median (range) interval time between orthotopic bladder substitute surgery and starting treatment was 7 (3-10) months and 6.5 (3-10) months in the placebo and mebeverine group, respectively (p=0.3). Compared to the baseline evaluation, the 3-month urinary domain of Bladder Cancer Index scores improved in both groups with significant improvement in the mebeverine group. The mean±SD 3-month urinary domain of Bladder Cancer Index was 67.79±13.05 and 83.27±12.21 in the placebo and mebeverine group, respectively (p <0.001). Also, the 3-month patient pad use decreased to 30 (63.8%) and 19 (36.5%) patients in the placebo and mebeverine group, respectively (p=0.007). Constipation occurred in 1 (2.1%) and 3 (5.8%) patients in the placebo and mebeverine group, respectively; abdominal distention occurred in 2 (3.8%) in the mebeverine group (p=0.25). CONCLUSIONS: Mebeverine accelerated continence development in male patients with ileal orthotopic bladder substitute during the first year post-orthotopic bladder substitute construction.