Efficacy and safety of intraprostatic temperature-controlled microwave thermotherapy in patients with benign prostatic hyperplasia: Results of a prospective, open-label, single-center study with 1-year follow-up

Background and Purpose: Different devices for transurethral microwave thermotherapy (TUMT) are currently available for the treatment of benign prostatic hyperplasia (BPH). We evaluated the efficacy and safety of the Prostalund Feedback Treatment(R) (PLFT(R)), which continuously records the intraprostatic temperature, and its impact on sexual function of the patients. Patients and Methods: A total of 41 patients with lower urinary tract symptoms attributed to BPH were entered in this prospective open-label, single-center study of PLET. The initial evaluation was performed according to a standard protocol. At 3, 6, and 12 months, the International Prostate Symptom Score (IPSS), bother score, sexual function, and peak flow rate (Q(max)) were recorded. In addition, determination of prostate volume by transrectal ultrasonography (TRUS) and measurement of residual urine volume were repeated at the 6- and 12-month visits. All adverse events were also recorded. Patients with IPSS of less than or equal to7, greater than or equal to50% improvement in IPSS from baseline, a Q(max) of greater than or equal to15 mL/sec, or greater than or equal to50% improvement in Q(max) from baseline were judged responders to the treatment. Results: Thirty-three of the patients completed the 12-month visit. The response rate was 88% (29 of 33 patients). There was a statistically significant decrease in IPSS at the 12-month visit, the mean IPSS being 7.1 v 21.9 at baseline (P <0.001). The mean IPSS was 10.3 and 7.6 at the 3- and 6-months' follow-up, respectively. The bother score presented a similar improvement, with a decrease from a mean of 4.2 at baseline to a mean of 1.4 after 12 months (P <0.001). The mean Q(max) improved from 8.4 mL/sec at baseline to 15.9 mL/sec, 19.2 mL/sec, and 17.8 mL/sec at 3, 6, and 12 months, respectively (P <0.001). The mean change in prostate volume, as determined by TRUS, was 16 mL at 6 months and 19 mL at 12 months (P <0.001). The procedure was well tolerated. The mean post-treatment catheterization time was 17.90 days. Bladder spasms and urinary tract infection were the most common adverse events. Coitus ability remained practically unchanged after treatment (from 71% to 74.3%), but the number of patients with ejaculation decreased (from 78% to 51.4%). Conclusion: Our results indicate that PLFT is an effective and safe treatment for most patients with BPH