Statistical methodology
mild/moderate, prostate
PROSTATE
Subjects were randomized in 2:1 ratio to either iTind or control (sham) group, respectively. Randomization was conducted using permuted blocks stratified by center by using a central electronic data program.Subjects were divided into subgroups according to age (three subgroups: 50–60, 61–70, >70), prostate volume (three subgroups: ≤40, 41–60, >60), and baseline total SHIM score (five subgroups: no function, severe ED, moderate, mild/moderate, mild, and no ED). Within each subgroup, change from baseline in total IIEF score was compared between iTind and sham at 3 months visit, and within the iTind group at 12 months visit.Differences between the groups at 3 months were analyzed using a mixed linear model with group, baseline total IIEF score, and subgroup as predictors. Differences within the iTind group at 12 months were analyzed using a mixed linear model with baseline total IIEF score and subgroup as predictors. Only patients who arrived at 3 or 12 months visits were included in the analysis. Additionally, any patients that required BPH-related medications during the follow-up period were excluded from the analysis.Statistical analysis was done using SAS 9.4 (SAS Institute, Inc., Cary, NC, USA). Statistical significance was accepted at 