Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia

The primary objectives are:

  1. to assess the overall efficacy of PDE5 compared to placebo;
  2. to compare the efficacy of PDE5 to the existing medical treatments (α1-blockers and 5ARI);
  3. to compare the relative efficacy of PDE5 alone and in combination of PDE5 with other existing treatments in people with LUTS consistent with BPH.

The secondary objectives are:

  1. to assess the efficacy of PDE5 on BPH-LUTS used at different doses;
  2. to compare the efficacy of PDE5 in patients with ED versus those who do not have ED;
  3. to evaluate the effect of PDE5 on LUTS in patients who had previously been treated with α1-blockers versus treatment naive patients;
  4. to analyse the long term efficacy of PDE5 on LUTS;
  5. to assess the safety of PDE5 in the short term (used at least for 4 weeks) as well as long term (used at least for 1 year).

This is a protocol.