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Paris-Microwave thermotherapy is a safe, noninvasive treatment modality that challenges transurethral resection of the prostate as a first-line choice of treatment in patients with BPH, Scandinavian researchers said here at the European Association of Urology annual congress.
Anders Mattiasson MD, professor of urology, Lund University Hospital, Lund, Sweden, reported on results of a prospective, randomized, multicenter study comparing the safety and efficacy of CoreTherm (ProstaLund, Inc., Culver City, CA) microwave treatment (PLFT) and TURP procedures, with a follow-up of 5 years.
"Long-term follow-up of adverse events during the post-treatment period up to 5 years did not demonstrate any major safety concerns for the ProstaLund CoreTherm microwave treatments in patients with BPH. Therefore, it may be one of the best minimally invasive procedures that can be performed in an outpatient setting, and [it] challenges TURP as the preferred first-line routine treatment of patients with symptomatic BPH," Dr. Mattiasson said.
TURP procedures were carried out using standard routines at each center.
The primary efficacy value in patients was determined using the International Prostate System Score (IPSS). Secondary variables were bother score, Qmax, prostate volume, residual urine volume, and adverse events.
Patients were followed up at 3, 6, 12, 24, 36, 48, and 60 months post-treatment. The 4-to 5-year follow-up period included data on 104 patients (68%) included in the study (69 patients in the microwave group and 35 in the TURP group).
Subjective improvement, based on IPSS results, was similar in both groups. At 3 months, researchers observed a significant decrease in the mean IPSS from 21 to 8 in the microwave therapy group, and from 20 to 7 in the TURP group, sustained over the 5 years, ultimately revealing no statistical difference between the two treatment methods. The same pattern also was seen in patients' bother scores. Although Qmax values were slightly better in patients in the TURP group, no significant statistical difference was seen between the two groups, Dr. Mattiasson reported.
At the end of the 5-year study, the frequency of severe treatment-related adverse events was 5% in the microwave therapy group and 17% in the TURP group, a statistically significant difference. Severe adverse events in the microwave therapy group included hematuria, urinary retention, and bladder stones.
In the TURP group, severe adverse events included hematuria, urinary tract infections, urosepsis, TURP syndrome, and clot retention. During the 1-to 5-year follow-up period, the number of non-serious adverse events was less in the microwave therapy group (31%) than in the TURP group (54%), researchers said.
Jacob Ramon, MD, a panelist hosting the session, asked which treatment technique is more advantageous postoperatively.
"There are advantages and disadvantages for both methods, the disadvantages with TURP being well known," Dr. Mattiasson responded. "However, with PLFT, we see that the patients normally need a catheter for 2 weeks after treatment. At present, we are in the process of developing a stent that the patient can self-monitor, and so avoid the need for a regular catheter.
"Another disadvantage with PLFT is that tissue is not removed post-PLFT, so that when you remove the catheter after 2 weeks, patients complain of more urgency initially, compared to the TURP patients," he added. "However, these symptoms subside relatively quickly in the first few months post-PLFT. Also, after 1 to 5 years post-treatment, the occurrence of urgency is much lower in the PLFT group (less than 3%) compared to 30% in the TURP group."