Five-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study.

OBJECTIVES: To compare the efficacy and safety of transurethral microwave thermotherapy (TUMT) with ProstaLund Feedback Treatment, using the CoreTherm device, with transurethral resection of the prostate (TURP) 5 years after treatment. METHODS: This prospective, randomized, multicenter study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to TUMT or TURP in a 2:1 ratio. Patients were followed up at 3, 6, 12, 24, 36, 48, and 60 months after treatment. The intermediate results at 12 and 36 months have been previously reported. The treatment outcome at 5 years was evaluated with the International Prostate Symptom Score (IPSS), quality of life question (QOL), peak urinary flow rate (Qmax), postvoid residual urine volume, and prostate volume. The CoreTherm device differs from other microwave devices in that the intraprostatic temperature is constantly measured during the procedure to guide the treatment. RESULTS: Of the 154 patients, 66% completed the 60 months of follow-up. Statistically significant improvements in the TUMT and TURP groups were observed for IPSS, QOL, and Qmax at 60 months. The average values for the TUMT group were an IPSS of 7.4, QOL score of 1.1, and Qmax of 11.4 mL/s. The values for the TURP group were IPSS of 6.0, QOL score of 1.1, and Qmax of 13.6 mL/s. No statistically significant differences were found in any of these variables between the two treatment groups. In the TUMT group, 10% needed additional treatment versus 4.3% in the TURP group. CONCLUSIONS: The clinical outcome 5 years after TUMT using the CoreTherm device was comparable to the results seen after TURP. The safety of TUMT using the CoreTherm device compared favorably with that of TURP.

Three-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study.

OBJECTIVES: To compare, in a prospective randomized multicenter study, the efficacy and safety of transurethral microwave thermotherapy with ProstaLund Feedback Treatment (PLFT), using the CoreTherm device, with transurethral resection of the prostate (TURP) 36 months after treatment. METHODS: The study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to PLFT or TURP in a 2:1 ratio. The treatment outcome was evaluated on the basis of the International Prostate Symptom Score (IPSS), the quality-of-life question (QOL) of the IPSS, peak urinary flow rate (Qmax), urodynamics, and adverse events. The microwave power and treatment time were adjusted according to each patient's response to the supplied energy (ie, the intraprostatic temperature guided the PLFT). RESULTS: Statistically significant improvements in both the TURP and the PLFT groups were observed for IPSS, QOL, and Qmax at 36 months. The average value for the PLFT group was 8.2, 1.2, and 11.9 mL/s for IPSS, QOL, and Qmax, respectively. The corresponding values for the TURP group were IPSS 5.0, QOL 1.0, and Qmax 13.5 mL/s. The difference in IPSS outcome was statistically significant; however, no statistically significant differences were found in QOL or Qmax between the two treatment groups. The degree of improvement was in the same range as that observed after 12 and 24 months for both groups. During the 12 to 36-month period, the most frequent adverse events in the TURP group were impotence (15%), micturition urgency (13%), and urethral disorder (8%); in the PLFT group, impotence (8%), prostate-specific antigen increase (5%), and hematuria (4%) were the most common. CONCLUSIONS: The clinical outcome 3 years after microwave thermotherapy with PLFT was comparable to the results seen after TURP. The safety of PLFT compared favorably to that of TURP in this study.

Feedback microwave thermotherapy versus TURP for clinical BPH--a randomized controlled multicenter study.

OBJECTIVES: To compare the outcome of a microwave thermotherapy feedback system that is based on intraprostatic temperature measurement during treatment (ProstaLund Feedback Treatment or PLFT) with transurethral resection of the prostate (TURP) for clinical benign prostatic hyperplasia (BPH) in a randomized controlled multicenter study. The safety of the two methods was also investigated. METHODS: The study was performed at 10 centers in Scandinavia and the United States. A total of 154 patients with clinical BPH were randomized to PLFT or TURP (ratio 2:1); 133 of them completed the study and were evaluated at the end of the study 12 months after treatment. Outcome measures included the International Prostate Symptom Score (IPSS), urinary flow, detrusor pressure at maximal urinary flow (Qmax), prostate volume, and adverse events. Patients were seen at 3, 6, and 12 months. Responders were defined according to a combination of IPSS and Qmax: IPSS 7 or less, or a minimal 50% gain, and/or Qmax 15 mL/s or greater or a minimal 50% gain. RESULTS: No significant differences in outcome at 12 months were found between PLFT and TURP for IPSS, Qmax, or detrusor pressure. The prostate volume measured with transrectal ultrasonography was reduced by 30% after PLFT and 51% after TURP. Serious adverse events related to the given treatment were reported in 2% after PLFT and in 17% after TURP. Mild and moderate adverse events were more common in the PLFT group. With the criteria mentioned above, 82% and 86% of the patients were characterized as responders after 12 months in the PLFT and TURP groups, respectively. The post-treatment catheter time was 3 days in the TURP group and 14 days in the PLFT group. CONCLUSIONS: The outcome of microwave thermotherapy with intraprostatic temperature monitoring was comparable with that seen after TURP in this study. From both a simplicity and safety point of view, PLFT appears to have an advantage. Taken together, our findings make us conclude that within a 1-year perspective microwave thermotherapy with PLFT is an attractive alternative to TURP in the treatment of BPH.