The primary objectives are:
- to assess the overall efficacy of PDE5 compared to placebo;
- to compare the efficacy of PDE5 to the existing medical treatments (α1-blockers and 5ARI);
- 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:
- to assess the efficacy of PDE5 on BPH-LUTS used at different doses;
- to compare the efficacy of PDE5 in patients with ED versus those who do not have ED;
- to evaluate the effect of PDE5 on LUTS in patients who had previously been treated with α1-blockers versus treatment naive patients;
- to analyse the long term efficacy of PDE5 on LUTS;
- 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.