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

Abstract

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^® (PLFT^®), 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 PLFT. 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 ≤7, ≥50% improvement in IPSS from baseline, a Q_max of ≥15 mL/sec, or ≥50% 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.