- Email: [email protected]
Discussion following Dr. Blute’S presentation
37. Ramsey EW, Miller PD, and Parsons K: Durability of results with transurethral microwave thermotherapy for symptomatic benign prostatic hyperplasia using the Targis (T3) system. J Urol 159: 304, 1998. Abstract 1175. 38. Blute ML, Larson TR, Hanson KA, et al: Current status of transurethral thermotherapy at the Mayo Clinic. Mayo Clin Proc 73: 597– 602, 1998. 39. Blute ML, Hanson K, Lynch J, et al: United States Prostatron TUMT study: 4 year follow-up and quality of life. J Urol 155: 403A, 1996. Abstract 370. 40. Walden M, Dahlstrand C, Schafer W, et al: How to select patients suitable for transurethral microwave thermo-
therapy: a systematic evaluation of potentially predictive variables. Br J Urol 81: 817– 822, 1998. 41. Blute M, Ackerman SJ, Rein AL, et al: Cost-effectiveness of microwave thermotherapy in patients with benign prostatic hyperplasia. II. Results. Urology 56: 981–987, 2000. 42. D’Ancona FC, Fracisca EA, Witjes WP, et al: Transurethral resection of the prostate vs high-energy thermotherapy of the prostate in patients with benign prostatic hyperplasia: long-term results. Br J Urol 81: 259 –264, 1988. 43. Naslund MJ, and Stitcher MF: A cost comparison of TUNA v TURP. J Urol 157(suppl): 155A, 1997.
DISCUSSION FOLLOWING DR. BLUTE’S PRESENTATION Michael P. O’Leary, MD, MPH (Boston, Massachusetts): It is particularly intriguing that reimbursement may be better for conducting a microwave procedure in the office than for a radical prostatectomy in the operating room. Steven A. Kaplan, MD (New York, New York): Histologically, the microwave procedure looks very similar to waterinduced thermotherapy. For the most part, the data are about the same in terms of improvement in the experience. However, a urologist who practices in the community would look at the reimbursement rate—the water-induced thermotherapy machine will be approximately $8000 or $10000, and the catheter costs will be somewhat less. Will that become the driving factor in the decision-making process? Michael L. Blute, MD (Rochester, Minnesota): I think that urologists are going to go for the most tolerable treatment that they can provide in their office for the least amount of bother. The transurethral microwave therapies are powerful devices that destroy and ablate prostate tissue, but patients have to be selected carefully. The safety profile of the hot water balloon is probably somewhat better than that of the transurethral microwave thermal therapy. However, we have to determine if patients can tolerate 1 to 3 weeks of catheterization. Franklin C. Lowe, MD, MPH (New York, New York): Is there a difference in length of time for catheterizations for the various thermal therapies? Dr. Blute: Yes, in our experience, 36% were found to have prolonged catheterization with the Prostatron (EDAP Technomed, Cambridge, MA) compared with only 3% with the target system. William D. Steers, MD (Charlottesville, Virginia): In 1 of the longest studies on thermotherapy using the high-energy 3.5 protocol, a cost analysis was conducted comparing thermotherapy with transurethral resection of the prostate (TURP). Patients were randomized to 1 of the 2 treatments, and the conclusion was that thermotherapy is cost-effective. Length of stay is much higher for TURP, which makes a major difference, but an examination of the data will show that significant flow rates and symptom scores after 4 years continued to decrease in the group that received microwave thermotherapy, whereas those who underwent TURP remained the same. Dr. O’Leary: Based on our collective experience, it is plausible that the durability of response for these minimally invasive therapies is not the same as it is for the “gold standard,” TURP. We can hope that the minimally invasive surgical therapy trial that the National Institutes of Health (NIH) is intend40
ing to fund will answer some of those questions. Among the most powerful issues that will intervene is the question of reimbursement. For the average urologist, a durability period of 2 or 3 years may be acceptable, because the reimbursement factor will become an incentive to repeat treatment. Claus G. Roehrborn, MD (Dallas, Texas): This is a wonderful opportunity for the NIH to conduct these technology assessment trials. However, if the NIH findings are not favorable, the insurance companies will not reimburse such treatment. Dr. Steers: We cannot make decisions based on a study of 100 or 150 patients. There are other risks that have to be considered, such as anesthesia and anticoagulation factors, among others. If any of these therapies are conducted on a 50-year-old patient, it is highly likely that the patient will need treatment again 15 years later. Such long-term ramifications have to be studied. Dr. Blute: A most crucial safety element of these thermotherapies is the energy levels that are used. Sometimes high energy levels, such as the 3.5 protocol, are used, which affects nontarget tissues, and it can become almost as invasive as resection. Our goal with these treatments is to make them as minimally invasive as possible, and actually conduct them as an outpatient or office procedure. I think an important aspect about this treatment is that it can be done without any sedation and anesthesia. Dr. O’Leary: In my experience, the only procedure described here that is truly an outpatient procedure is the microwave therapy. The transurethral needle ablation (TUNA) is a procedure that needs some sedation. Also, the indigo laser is not very different from TURP. So instead of using these, it would be better to use the resectoscope, because the improvement in symptom response with the latter is dramatic. Dr. Kaplan: Clearly, the interstitial laser and TUNA procedures are much harder to use in a local procedure. Community urologists are not going to invest the time when they can conduct a procedure, such as the microwave therapy, which can be done in the office and is much easier to reproduce. So given that and the economic concerns, are the interstitial laser and TUNA on their deathbed? Dr. Blute: I don’t think so. I think that they are going to retain their place for use in a combination of minimally invasive therapies. Dr. Roehrborn: Based on the data shown here, minimally UROLOGY 58 (Supplement 6A), December 2001
invasive therapies are probably more effective than medical therapy, but the fundamental problem is introduced by the US Food and Drug Administration and the rules and regulations under which phase 2 trials are done. Every medication currently available has come to market with pivotal trials in which the value of the symptom score at the time of randomization forms the baseline from which the effect is calculated. However, at that time, the placebo is already in effect and can easily
UROLOGY 58 (Supplement 6A), December 2001
change the findings by a couple of points. How do you account for such placebo effects? Dr. Blute: Yes, unfortunately the patients we see are all receiving medical therapy. It is very apparent that we are not seeing most patients with problems with benign prostatic hyperplasia (BPH). There is definitely a risk-averse and non– risk-averse population of patients with BPH, and we are seeing the non–risk-averse population.
41
therapy: a systematic evaluation of potentially predictive variables. Br J Urol 81: 817– 822, 1998. 41. Blute M, Ackerman SJ, Rein AL, et al: Cost-effectiveness of microwave thermotherapy in patients with benign prostatic hyperplasia. II. Results. Urology 56: 981–987, 2000. 42. D’Ancona FC, Fracisca EA, Witjes WP, et al: Transurethral resection of the prostate vs high-energy thermotherapy of the prostate in patients with benign prostatic hyperplasia: long-term results. Br J Urol 81: 259 –264, 1988. 43. Naslund MJ, and Stitcher MF: A cost comparison of TUNA v TURP. J Urol 157(suppl): 155A, 1997.
DISCUSSION FOLLOWING DR. BLUTE’S PRESENTATION Michael P. O’Leary, MD, MPH (Boston, Massachusetts): It is particularly intriguing that reimbursement may be better for conducting a microwave procedure in the office than for a radical prostatectomy in the operating room. Steven A. Kaplan, MD (New York, New York): Histologically, the microwave procedure looks very similar to waterinduced thermotherapy. For the most part, the data are about the same in terms of improvement in the experience. However, a urologist who practices in the community would look at the reimbursement rate—the water-induced thermotherapy machine will be approximately $8000 or $10000, and the catheter costs will be somewhat less. Will that become the driving factor in the decision-making process? Michael L. Blute, MD (Rochester, Minnesota): I think that urologists are going to go for the most tolerable treatment that they can provide in their office for the least amount of bother. The transurethral microwave therapies are powerful devices that destroy and ablate prostate tissue, but patients have to be selected carefully. The safety profile of the hot water balloon is probably somewhat better than that of the transurethral microwave thermal therapy. However, we have to determine if patients can tolerate 1 to 3 weeks of catheterization. Franklin C. Lowe, MD, MPH (New York, New York): Is there a difference in length of time for catheterizations for the various thermal therapies? Dr. Blute: Yes, in our experience, 36% were found to have prolonged catheterization with the Prostatron (EDAP Technomed, Cambridge, MA) compared with only 3% with the target system. William D. Steers, MD (Charlottesville, Virginia): In 1 of the longest studies on thermotherapy using the high-energy 3.5 protocol, a cost analysis was conducted comparing thermotherapy with transurethral resection of the prostate (TURP). Patients were randomized to 1 of the 2 treatments, and the conclusion was that thermotherapy is cost-effective. Length of stay is much higher for TURP, which makes a major difference, but an examination of the data will show that significant flow rates and symptom scores after 4 years continued to decrease in the group that received microwave thermotherapy, whereas those who underwent TURP remained the same. Dr. O’Leary: Based on our collective experience, it is plausible that the durability of response for these minimally invasive therapies is not the same as it is for the “gold standard,” TURP. We can hope that the minimally invasive surgical therapy trial that the National Institutes of Health (NIH) is intend40
ing to fund will answer some of those questions. Among the most powerful issues that will intervene is the question of reimbursement. For the average urologist, a durability period of 2 or 3 years may be acceptable, because the reimbursement factor will become an incentive to repeat treatment. Claus G. Roehrborn, MD (Dallas, Texas): This is a wonderful opportunity for the NIH to conduct these technology assessment trials. However, if the NIH findings are not favorable, the insurance companies will not reimburse such treatment. Dr. Steers: We cannot make decisions based on a study of 100 or 150 patients. There are other risks that have to be considered, such as anesthesia and anticoagulation factors, among others. If any of these therapies are conducted on a 50-year-old patient, it is highly likely that the patient will need treatment again 15 years later. Such long-term ramifications have to be studied. Dr. Blute: A most crucial safety element of these thermotherapies is the energy levels that are used. Sometimes high energy levels, such as the 3.5 protocol, are used, which affects nontarget tissues, and it can become almost as invasive as resection. Our goal with these treatments is to make them as minimally invasive as possible, and actually conduct them as an outpatient or office procedure. I think an important aspect about this treatment is that it can be done without any sedation and anesthesia. Dr. O’Leary: In my experience, the only procedure described here that is truly an outpatient procedure is the microwave therapy. The transurethral needle ablation (TUNA) is a procedure that needs some sedation. Also, the indigo laser is not very different from TURP. So instead of using these, it would be better to use the resectoscope, because the improvement in symptom response with the latter is dramatic. Dr. Kaplan: Clearly, the interstitial laser and TUNA procedures are much harder to use in a local procedure. Community urologists are not going to invest the time when they can conduct a procedure, such as the microwave therapy, which can be done in the office and is much easier to reproduce. So given that and the economic concerns, are the interstitial laser and TUNA on their deathbed? Dr. Blute: I don’t think so. I think that they are going to retain their place for use in a combination of minimally invasive therapies. Dr. Roehrborn: Based on the data shown here, minimally UROLOGY 58 (Supplement 6A), December 2001
invasive therapies are probably more effective than medical therapy, but the fundamental problem is introduced by the US Food and Drug Administration and the rules and regulations under which phase 2 trials are done. Every medication currently available has come to market with pivotal trials in which the value of the symptom score at the time of randomization forms the baseline from which the effect is calculated. However, at that time, the placebo is already in effect and can easily
UROLOGY 58 (Supplement 6A), December 2001
change the findings by a couple of points. How do you account for such placebo effects? Dr. Blute: Yes, unfortunately the patients we see are all receiving medical therapy. It is very apparent that we are not seeing most patients with problems with benign prostatic hyperplasia (BPH). There is definitely a risk-averse and non– risk-averse population of patients with BPH, and we are seeing the non–risk-averse population.
41