Elsevier

Urology

Volume 64, Issue 4, October 2004, Pages 698-702
Urology

Adult urology
Three-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: A prospective randomized multicenter study

https://doi.org/10.1016/j.urology.2004.05.030Get rights and content

Abstract

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.

Section snippets

Study design

This controlled multicenter study involved 10 centers in Scandinavia and the United States. A total of 154 patients were enrolled in the study from October 1998 to November 1999 and were randomized in a 2:1 ratio to PLFT versus TURP. Eight patients (five in the TURP and three in the PLFT group) were withdrawn before treatment, resulting in a total of 146 patients treated: 100 with PLFT and 46 with TURP. The ethical committees in each respective country approved the study protocol, and all

Results

The results from the 12-month follow-up visit, which was the primary endpoint of the study, have previously been reported for the available 133 patients (91 PLFT and 42 TURP) of the 146 enrolled in the study.9 Thereafter, the study was extended, and the patients were asked to come for yearly follow-up visits until 5 years after treatment. Eleven patients in the PLFT group and three in the TURP group wished to withdraw from the study. We present the 24-month results for the 118 (79 PLFT and 39

Comment

Although microwave thermotherapy systems without intraprostatic temperature monitoring have demonstrated statistically significant clinical outcomes, especially for subjective variables, these results have not been in the same range as those after TURP when comparing objective variables such as flow and detrusor pressure.4, 5, 6

The long-term results from studies comparing transurethral microwave thermotherapy with TURP are sparse. However, the available evaluations of different transurethral

Conclusions

This is the first prospective randomized multicenter study comparing PLFT with TURP. Three years after treatment, considerable improvements were found in all outcome parameters (IPSS, QOL, Qmax, postvoid residual urine volume, and prostate volume) for both study groups compared with baseline. The difference in the IPSS was statistically significant between the PLFT and TURP groups; however, no statistically significant differences were found in QOL and Qmax between the two treatment groups. The

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This study was sponsored by ProstaLund.

L. Wagrell, S. Schelin, T. R. Larson, and A. Mattiasson are paid consultants to the sponsor.

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