BACKGROUND: This is the first head-to-head randomized clinical comparison of 2 transurethral microwave therapy (TUMT) devices for the treatment of benign prostatic hyperplasia (BPH). Results are presented for the 30 patients treated with either the Prolieve^® System or the Targis System. The study compares objective measures (catheterization rates), subjective measures (patient pain, AUA Symptom Score), and safety events.
METHODS: Males ≥45 years old with symptomatic BPH were randomized to single-treatment with either the Prolieve System or Targis System. Patients were treated according to the device manufacturers’ recommendations and followed for 6 months. All patients’ bladders were filled post-treatment with ≥200mL of saline. Patients were catheterized if unable to void by 2 hours or if post void residual was >150mL. All subsequent catheter use was documented at follow-up visits.
RESULTS: On study, 15/16 (94%) Prolieve patients remained catheter-free after treatment vs. 3/14 (21%) Targis patients (p=0.0001). The mean Visual Analog Scale (VAS) score during the total treatment period for Prolieve was 2.7 versus 4.6 for Targis. Device-related adverse events (AEs) were experienced by 31% (Prolieve) vs. 64% (Targis) of patients. The most prevalent AEs were urinary retention (1 Prolieve, 7 Targis), dysuria (1 Prolieve, 3 Targis), and hematuria (4 Targis). No device-related serious adverse events occurred on study. AUA Symptom scores improved by 55% (Prolieve) and 22% (Targis) at 1 month over baseline and 60% (Prolieve) and 52% (Targis) at 6 months over baseline.
CONCLUSIONS: Study results demonstrate that, compared with the Targis System, Prolieve treated patients required significantly fewer catheterizations (P=0.0001). Study results also suggest that Prolieve patients experienced faster initial symptomatic relief and had better treatment tolerability. To statistically demonstrate these endpoints, further research is required.