9% to a total volume of 5ml. All patients received five injections of 1mL of the BoNT-A solution, including two injections in each lateral lobe (one proximal and one distal) and one injection in the selleck chemical medium lobe. The injection depth was 7�C10mm. After the procedure, patients remained under observation until they were able to void spontaneously without hematuria. Oral levofloxacin (500mg once a day) was administered for five days. 2.2. FollowupEvaluations were performed 3 and 6 months after treatment and included a clinical assessment of LUTS with the IPSS score as well as measurement of peak urinary flow rate, postvoid residual volume, serum PSA levels, and prostate volume. The primary endpoint was improvement of IPSS scores. 2.3. Statistical AnalysesData were expressed as means �� standard deviation (SD) and range or absolute values and fractions.

Intergroup changes from baseline of continuous variables were analyzed with analysis of variance for repeated measurements. Intragroup comparisons were performed using the Student’s paired t-test. Fisher’s test was used for categorical variables. A sample size of 17 in each group has 80% power to detect a difference between means of 3.00 (units in the IPSS score), at a two-tailed significance level of 0.05 or less. Data were processed using commercially available statistical software (GraphPad Prism, version 5.00 for Windows, San Diego, CA, USA).3. ResultsWe prospectively enrolled 36 patients in this 6-month open-label study. Two patients that failed to return for the follow-up evaluations were excluded.

A total of 34 patients completed the study, including 17 in the BoNT-A 100U group and 17 in the BoNT-A 200U group. No differences were found at baseline between the two groups, including age, IPSS, Qmax , PVR, PSA, and PV (Table 1).Table 1Baseline characteristics of patients treated with intraprostatic BoNT-A.The comparison between baseline characteristics Brefeldin_A and outcome measures 3 and 6 months after treatment are demonstrated in Table 2. Statistically significant changes in IPSS, Qmax , and PVR were observed at 3rd and 6th months evaluations with both doses of BoNT-A (Figures (Figures1,1, ,2,2, and and3).3). Figure 1Mean IPSS of 34 patients treated with 100 and 200U of intraprostatic BoNT-A.Figure 2Mean Qmax of 34 patients treated with 100 and 200U of intraprostatic BoNT-A.Figure 3Mean PVR of 34 patients treated with 100 and 200U of intraprostatic BoNT-A.Table 2Mean and percentage change from baseline of International Prostatic Symptom Score (IPSS), maximum urinary flow rate (Qmax ), pos-void residual volume (PVR), PSA levels and prostate volume after 3 and 6 months of treatment.PSA levels were significantly reduced after six months of BoNT-A 100U injection but not after three months.