A controlled, randomized, head-to-head comparison of the Prolieve thermodilatation System versus the Targis System for benign prostatic hyperplasia: safety, procedural tolerability, and clinical results

Abstract

Purpose: Compare safety and tolerability of the Prolieve(®) System with the Targis(®) System using objective and subjective measures.

Patients and methods: Thirty-four men with symptomatic benign prostatic hyperplasia (BPH) were randomized to a single treatment with either the Prolieve or Targis system; 30 were treated and then followed for 6 months. After post-treatment bladder fill with ≥200 mL saline, patients were catheterized if they could not void after 2 hours or had a postvoid residual >150 mL. Catheter use, visual analog scale (VAS) tolerability scores, American Urological Association scores, and safety were assessed.

Results: After treatment, 15/16 (94%) Prolieve patients remained catheter-free compared with 3/14 (21%) Targis patients (P = 0.0001). Foley catheter indwelling time was 58.8 hours for the one Prolieve patient compared with 103.9 hrs (range 54-270 h) for the Targis patients (n = 9). Targis patients' catheterization requirements were: Seven Foley only, two intermittent self-catheters only, and two needing both. Intermittent self-catheterization continued for 1 month in two Targis patients. VAS tolerability scores were 24% to 50% lower during Prolieve treatment vs Targis (P < 0.05). Mean AUA scores for Prolieve improved from 21.2 at baseline to 12.3 and 7.9 at week 2 and month 6, respectively; for Targis, AUA scores improved from 22.9 at baseline to 17.9 and 10.9, respectively (P > 0.05). Overall, the incidence of device-related adverse events was 31% (Prolieve) compared with 64% (Targis) (P > 0.05)-most prevalently, urinary retention, dysuria, and hematuria. No device-related serious adverse events occurred.

Conclusions: Prolieve provided enhanced near-term therapeutic benefit over Targis as assessed by catheterization, tolerability, and symptom relief, which may assist physician and patient decision-making when selecting an office-based transurethral microwave therapy option for patients.