- Patient is diagnosed with symptomatic Benign Prostatic Hyperplasia based on detailed medical history, physical examination, including a urinalysis, and the assessment of renal function, Uroflowmetry, and Post-Void Residual urine measurements (PVR).
- Patient has defined lower and upper size limits of the prostate (set by sponsor’s expectation of therapy)
- The AUA symptom Index value should be a total score of > 13
- Peak urine flow rate < 12 ml/sec (Based on a voided volume > 150 ml).