REPLY BY AUTHORS
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LONG-TERM RESULTS OF LOWER ENERGY TRANSURETHRAL MICROWAVE THERMOTHERAPY 1973 older software for providing microwave thermotherapy energy to the prostate and decreasing lower urinary tract symptoms appears to provide early symptomatic improvement, which is significantly dif- ferent from placebo. However, the measured parameters, including flow rate, symptom score and residual urine, return to baseline between 24 and 60 months following treatment. While an argument can certainly be made that repeat treatments every 5 years with a low morbidity procedure may be reasonable for some patients, the cost of this technology requires significant capital outlay for initial use and does not appear to provide cost-effective treatment for BPH in men with lower urinary tract symptoms. We await further long- term studies with ProstasoR 2.5 to evaluate outcomes using more energy. These results should discourage urologists from significant investment in current transurethral microwave thermotherapy equipment, which appears to have durable improvement only in a minority of patients with lower urinary tract symptoms from BPH. Culley C. Carson, III Department of Urology University of North Carolina School of Medicine Chapel Hill, North Carolina REPLY BY AUTHORS At the outset of thermotherapy little was known about the ideal inclusion criteria, and large unselected groups of patients with vary- ing degrees of obstruction were treated. We did that to become familiar with the technology and to identify the most adequate responding group to this early, low energy generation of thermother- apy. The approval of transurethral microwave thermotherapy 2.0 by the Food and Drug Administration in May 1996 was based on 4 prospective clinical studies, including a 4-year followup study. The long-term safety and effectiveness of low energy thermotherapy were assessed and confirmed at that time as well as the treatment related morbidity. We now have confirmation that the more symptomatic andor obstructive patients do not respond well to low energy microwave thermotherapy. The prostate probably has been insufficiently heated for inducing longlasting clinical response. However, we also have confirmation that the symptomatic patients with moderate obstruc- tion do respond well to low energy transurethral microwave thermo- therapy, with minimal morbidity. To our knowledge, the low energy transurethral microwave thermotherapy 2.0 is reserved in the United States for patients with the indications previously described, thus, limiting significantly the number of nonresponders. High energy thermotherapy 2.5 was approved by the Food and Drug Administration in November 1997, confirming the safety and effectiveness of microwave thermotherapy with the Prostatron. High energy microwave thermotherapy is now proposed to patients with a higher degree of obstruction who would not have responded ade- quately to the low energy program. The high energy program is also associated with the use of a urethral treatment catheter which focuses the microwave energy in the bladder neck, a key factor for obtaining steady and sustained relief of obstruction. Our center is currently gathering 3-year followup data on our first patients treated with the high energy 2.5 program. Our preliminary results clearly indicate the sustainability of the clinical outcome, even in the seri- ously obstructed cases. We recognize the limitations of lower energy thermotherapy treat- ment. Proper patient selection is the key issue in this respect. How- ever, proper selection accounts for any given treatment, including the gold standard transurethral prostatic resection. One should re- frain from resecting large prostates while the outcome following resection in symptomatic nonobstructed patients is also not favor- able. We believe that microwave thermotherapy represents an excit- ing alternative in these cases. Moreover, patients in whom drug therapy has failed but who do not wish to undergo transurethral prostatic resection and high risk patients not suitable for transure- thral prostatic resection may be considered for this low energy trans- urethral microwave thermotherapy.
Transcript of REPLY BY AUTHORS
LONG-TERM RESULTS OF LOWER ENERGY TRANSURETHRAL MICROWAVE THERMOTHERAPY 1973 older software for providing microwave thermotherapy energy to the prostate and decreasing lower urinary tract symptoms appears to provide early symptomatic improvement, which is significantly dif- ferent from placebo. However, the measured parameters, including flow rate, symptom score and residual urine, return to baseline between 24 and 60 months following treatment. While an argument can certainly be made that repeat treatments every 5 years with a low morbidity procedure may be reasonable for some patients, the cost of this technology requires significant capital outlay for initial use and does not appear to provide cost-effective treatment for BPH in men with lower urinary tract symptoms. We await further long- term studies with ProstasoR 2.5 to evaluate outcomes using more energy. These results should discourage urologists from significant investment in current transurethral microwave thermotherapy equipment, which appears to have durable improvement only in a minority of patients with lower urinary tract symptoms from BPH.
Culley C. Carson, III Department of Urology University of North Carolina School of Medicine Chapel Hill, North Carolina
REPLY BY AUTHORS
At the outset of thermotherapy little was known about the ideal inclusion criteria, and large unselected groups of patients with vary- ing degrees of obstruction were treated. We did that to become familiar with the technology and to identify the most adequate responding group to this early, low energy generation of thermother- apy. The approval of transurethral microwave thermotherapy 2.0 by the Food and Drug Administration in May 1996 was based on 4 prospective clinical studies, including a 4-year followup study. The long-term safety and effectiveness of low energy thermotherapy were assessed and confirmed a t that time as well as the treatment related morbidity.
We now have confirmation that the more symptomatic andor
obstructive patients do not respond well to low energy microwave thermotherapy. The prostate probably has been insufficiently heated for inducing longlasting clinical response. However, we also have confirmation that the symptomatic patients with moderate obstruc- tion do respond well to low energy transurethral microwave thermo- therapy, with minimal morbidity. To our knowledge, the low energy transurethral microwave thermotherapy 2.0 is reserved in the United States for patients with the indications previously described, thus, limiting significantly the number of nonresponders.
High energy thermotherapy 2.5 was approved by the Food and Drug Administration in November 1997, confirming the safety and effectiveness of microwave thermotherapy with the Prostatron. High energy microwave thermotherapy is now proposed to patients with a higher degree of obstruction who would not have responded ade- quately to the low energy program. The high energy program is also associated with the use of a urethral treatment catheter which focuses the microwave energy in the bladder neck, a key factor for obtaining steady and sustained relief of obstruction. Our center is currently gathering 3-year followup data on our first patients treated with the high energy 2.5 program. Our preliminary results clearly indicate the sustainability of the clinical outcome, even in the seri- ously obstructed cases.
We recognize the limitations of lower energy thermotherapy treat- ment. Proper patient selection is the key issue in this respect. How- ever, proper selection accounts for any given treatment, including the gold standard transurethral prostatic resection. One should re- frain from resecting large prostates while the outcome following resection in symptomatic nonobstructed patients is also not favor- able. We believe that microwave thermotherapy represents an excit- ing alternative in these cases. Moreover, patients in whom drug therapy has failed but who do not wish to undergo transurethral prostatic resection and high risk patients not suitable for transure- thral prostatic resection may be considered for this low energy trans- urethral microwave thermotherapy.
