Clinical Study

Botulinum Neurotoxin Type A for the Treatment of Benign Prostatic Hyperplasia: Randomized Study Comparing Two Doses

Table 2

Mean and percentage change from baseline of International Prostatic Symptom Score (IPSS), maximum urinary flow rate ( ), pos-void residual volume (PVR), PSA levels and prostate volume after 3 and 6 months of treatment.

BoNT-A 100 UChange %BoNT-A 200 UChange %P value

IPSS
 Baseline22.1 ± 6.422.8 ± 6.9
 3rd month8.0 ± 4.4*−64%9.5 ± 4.2*−58%0.767
 6th month7.5 ± 4.3*−66%9.2 ± 3.4*−60%0.657
(mL/s)
 Baseline8.6 ± 3.18.4 ± 3.2
 3rd month12.8 ± 3.6*49%11.2 ± 4.8*33%0.564
 6th month10.9 ± 3.4*27%11.4 ± 3.2*36%0.927
PVR (mL)
 Baseline131.8 ± 65.0121.1 ± 73.7
 3rd mo39.1 ± 33.5*−70%48.1 ± 24.4*−60%0.466
 6th mo38.5 ± 31.2*−69%51.7 ± 24.7*−57%0.311
PSA (ng/dL)
 Baseline3.9 ± 4.14.1 ± 2.7
 3rd mo3.2 ± 3.3 ns−18%3.0 ± 2.1*−27%0.426
 6th mo3.0 ± 2.5*−23%2.7 ± 1.7*−34%0.421
Prostate volume (mL)
 Baseline42.3 ± 18.543.1 ± 19.7
 3rd mo38.9 ± 16.1 ns−8%39.8 ± 17.7 ns−8%0.961
 6th mo38.6 ± 16.6 ns−9%37.8 ± 15.5*−13%0.561

Statistical significance between groups (intergroup comparison) (Student's t-test).
Statistical significance within groups: *P < 0.05 versus baseline, ns (not significance versus baseline).
(Repeated measures ANOVA and Dunnett's posttest).