Introduction: Five US centers are conducting an IDE study with the Cooled ThermoCath^® (CTC) from Urologix, Inc. The CTC has an advanced cooling system that is intended to allow it to achieve the same or better outcomes and tissue necrosis as a Targis 60-minute treatment, in a 28.5-minute high-temperature treatment. We previously presented treatment tolerance data and 6-month outcome data that supported this intent. Long-term outcome data is now becoming available.
Methods: 66 patients received a single 28.5-minute high temperature CTC treatment in an outpatient setting with oral and topical analgesia only. Primary enrollment criteria included AUA Symptom Score ≥ 8 and peak urinary flow rate (Qmax) ≤ 15 mL/sec. Follow-up evaluations were scheduled for 1 week, 6 weeks, 3, 6, and 12 months using AUA Symptom Score (AUASS), quality of life score (QOL), and Qmax. Patient satisfaction was also recorded beginning at 6 weeks post-treatment.
Results: At 12 and 24 months (n=62 and 33 to date), the improvement in Qmax, AUASS and QOL continues to be highly significant (all p<0.0001). Qmax increased from 8.3 ml/s at screening to 12.9 and 11.8; AUASS decreased from 20.8 to 8.5 and 9.9; and QOL improved from 3.9 to 1.7 and 1.9. Additionally at 12 and 24 months, 83.9% and 84.9% of patients expressed satisfaction with CTC treatment, while 77.4% and 75.8% of patients would probably or definitely recommend CTC treatment to others. None of the adverse events reported to date were considered severe, and rates have been similar to those reported for Targis patient cohorts from previous published studies.
Conclusion: The CTC 28.5-minute treatment previously demonstrated similar or improved treatment comfort and safety compared to Targis 60-minute treatment, as well as impressive outcomes at 6 months. At 24 months post-treatment, the CTC continues to provide significant symptom improvement and patient satisfaction. Data will continue to be collected through 60 months to further support this conclusion.

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