Hypothesis / aims of study
LUTS affect the quality of life (QOL) of patients and it is important to know which symptoms bother patients. Symptom score such as IPSS and OABSS are useful to assess the severity of LUTS; however, the symptom-severity does not always correlate with patient-reported QOL (bother or satisfaction). The aim of this study is to evaluate the efficacy of tadalafil in men suggestive of benign prostatic hyperplasia with lower urinary tract symptoms and/or chronic prostatitis-like symptoms, focusing on patient-reported bother.
Study design, materials and methods
In this multicenter and prospective study, men ≥40 years with lower urinary tract symptoms and/or chronic prostatitis-like symptoms received 5 mg of tadalafil once daily for 4 weeks. This study was approved by the Institutional Review Board and informed consent to participate was received from all enrolled patients. We assessed the change from baseline to week 4 in the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and Visual Analog Scale (VAS) specific to each symptom. The most bothersome symptom at baseline was defined as the symptom with the highest VAS measures before treatment with tadalafil. When there were the multiple highest VAS measures, all the symptoms were considered to be the most bothersome. ∆VAS was calculated as post-treatment VAS measure minus pre-treatment VAS measure. If patients complained of perineal and/or ejaculatory pain or discomfort, and their total index pain score was 4 or greater, they were considered as having prostatitis-like symptoms. Patients who had prostatitis-like symptoms were evaluated between pre- and post-treatment using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
Results
190 patients were analyzed to compare the efficacy of Tadalafil between pre- and post-treatment. Of 190 patients, 73 had prior treatment with alpha-blockers and 117 had no prior treatment on LUTS. At the baseline, the mean (SD; standard deviation) patient age was 70 (9.3) years, the mean (SD) post-void residual urine volume was 34 (42) ml, and the mean (SD) prostate volume was 39 (23) ml. We found significant improvements in the post-treatment total IPSS (pre vs post, mean(SD) values; 18(6.5) vs 16(7.0), p<0.0001), including voiding symptoms (10(4.8) vs 8.8(4.9), p<0.0001), storage symptoms (7.8(3.0) vs 6.9(3.1), p<0.0001), and QOL (4.6(1.0) vs 4.0(1.4), p<0.0001). All VAS measures corresponding to each symptom in IPSS and OABSS were also significantly improved (p<0.001). The most bothersome symptoms at baseline evaluated by VAS improved significantly after treatment (p<0.001) (Table 1). Patients whose most bothersome symptoms at baseline included IPSS-Q1 (incomplete emptying) and Q3 (intermittency) showed significantly larger improvement on the considered symptom (incomplete emptying and intermittency) after treatment than those without them. On the other hand, patients whose most bothersome symptoms at baseline included IPSS-Q7 (nocturia) showed significantly smaller improvement after treatment than those without it (Table 2). On analysis of 29 patients with prostatitis-like symptoms, NCI-CPSI mean (SD) pain score (pre vs post; 9.6 (3.5) vs 6.1 (4.2), p<0.001) significantly improved after treatment.
Interpretation of results
In this study, we used the validated VAS-questionnaire to evaluate the patient-reported bother specific to each symptom of LUTS; and found that tadalafil significantly improved the bother. All symptoms in IPSS and OABSS which were the most bothersome at baseline significantly improved after treatment (p<0.001). Patients whose most bothersome symptoms at baseline included IPSS-Q7 (nocturia) showed significantly smaller improvement after treatment than those without it (p=0.024). Nocturia is affected by a lot of kind of medical condition, including heart failure, kidney disease, and OAB, which are both urologic and non-urologic in origin. These multiple factors may have affected lower improvement with bother on nocturia which assessed by patient reported bother.