Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000

David M. Albala, Joseph Nuzzarello, Chandru Sundaram, Brant R. Fulmer, Thomas M.T. Turk, Fernando Koleski, Gerald Andriole, Bradley E. Davis, Gregg R. Eure, John N. Kabalin, James E. Lingeman

Research output: Contribution to journalArticle

13 Scopus citations

Abstract

Background and Purpose: Transurethral microwave thermotherapy (TUMT) is an effective therapy for symptomatic benign prostatic hyperplasia (BPH), but the trade-off between the magnitude of clinical improvement and side effects and patient tolerance has limited its appeal to patients and urologists. This study, using the TherMatrx TMx-2000, a TUMT device that directly heats the transition zone to greater than 50°C, has been focused on resolving these issues and developing a truly office-based therapy that is well tolerated with a benign post-treatment course. Patients and Methods: This study was multi-institutional and designed as a blinded, randomized, and sham-controlled trial. A series of 200 patients with an AUA Symptom Index (AUASI) of >12, a peak flow rate of <12 mL/sec, and cystoscopic evidence of BPH were randomized 2:1 (active to sham) and treated in seven physician offices under a Food and Drug Administration-supervised and audited premarket approval protocol. No intravenous sedation was used in any patient. Follow-up for the sham-treatment group was 3 months, at which time, patients could cross over to an active treatment. A total of 119 patients have completed 1-year follow-up. Results: The active and sham groups were statistically identical at baseline. The 1-hour total treatment was extremely well tolerated using urethral lidocaine and oral medications; not a single prostate block or parental dose of medication was required. The active-treatment group demonstrated a statistically significant reduction (p < 0.05) in AUASI at 3 months compared with sham treatment, with an AUASI decrease from 22.4 to 12.4 (n = 124) for active v 22.9 to 17 for sham (n = 62). For the 119 patients in the active arm who have reached 12 months, the AUASI has fallen to 10.6 points (47.1% decrease), and the peak flow rate has increased 5.0 mL/sec (58.1%). Postprocedure catheterization was typically 2 or 3 days, and the 16.8% of patients who failed their first voiding trial all voided within 1 week. No major adverse events such as stricture, rectal findings, or ejaculatory changes have been reported. Conclusions: This study demonstrates that the TherMatrx TMx-2000 TUMT effectively treats symptomatic BPH in the physician office with minimal morbidity.

Original languageEnglish (US)
Pages (from-to)57-61
Number of pages5
JournalJournal of Endourology
Volume16
Issue number1
DOIs
StatePublished - Feb 2002
Externally publishedYes

ASJC Scopus subject areas

  • Urology

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    Albala, D. M., Nuzzarello, J., Sundaram, C., Fulmer, B. R., Turk, T. M. T., Koleski, F., Andriole, G., Davis, B. E., Eure, G. R., Kabalin, J. N., & Lingeman, J. E. (2002). Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000. Journal of Endourology, 16(1), 57-61. https://doi.org/10.1089/089277902753483745