Mid-term results of newer cooled TUMT device called 'encouraging'

May 26, 2005

Midpoint results of a 5-year multi-center IDE study comparing a new cooled transurethral microwave thermotherapy device against the conventional 60-minute Targis treatment (both from Urologix, Minneapolis) were announced here on Wednesday, and the data appear promising.

Midpoint results of a 5-year multi-center IDE study comparing a new cooled transurethral microwave thermotherapy device against the conventional 60-minute Targis treatment (both from Urologix, Minneapolis) were announced here on Wednesday, and the data appear promising.

The five-center study of 70 patients (mean age, 67.2 years +/-8.3 years) with BPH symptoms for 6.9+/-4.2 years and pretreatment prostate size of 49.4+/-21.5 grams were enrolled as outpatients to receive a single treatment with the new device, known as Cooled Thermocath (CTC). Patients received only oral and topical analgesia.

Enrollment criteria included a AUA Symptom Score ≥9 and a peak urinary flow rate (Qmax) ≤15 mL/sec. Treatment tolerance was measured with a visual analog scale of 0 to 10; follow-up consisting of AUA Symptom Scores (AUASS), quality of life (QoL) score, and Qmax was performed at 1 and 6 weeks, and 3, 6, and 12 months, and annually for 5 years.

Paired outcome data indicated similarities in AUASS, Qmax, and QoL scores for both treatments over time, although patients' average VAS pain score at the most uncomfortable point in the 28-minute CTC treatment was 2.9, compared with 4.5 for a previous 60-minute Targis treatment cohort, said lead study author Claus G. Roehrborn, MD, professor and chairman of urology at the University of Texas Southwestern, Dallas. He noted that 47.6% of patients did not require post-treatment catheterization, 39.7% required only intermittent self-catheterization, and 12.7% (one patient for more than 1 week) required indwelling catheterization.

"The MRIs show that the area of necrosis induced by the shorter treatment was comparable with that of the older 60-minute treatment," Dr. Roehrborn told Urology Times. "Efficacy results were comparable with those of the longer treatment, but this catheter was better tolerated, no doubt about it.

"I was not surprised by the results. I am sure more patients will require re-treatment, and I am certain that it will be at a minimum of 5% per year, but that is true for every microwave treatment, every ILC, for TUNA, and the rest. It is the price you pay for efficacy."