2
HEAT SHOCK HIGH ENERGY MICROWAVE THERMOTHERAPY FOR BENIGN PROSTATIC HYF'ERPLASIA APPENDIX: INCLUSION AND EXCLUSION CRITERIA FOR TRANSURETHRAL MICROWAVE THERMOTHERAPY 781 Inclusion Criteria Exclusion Criteria Prostate vol. 25-70 ml. Madsen score 8 or greater Maximum flow rate 15 ml./sec. or less Residual urine vol. less than 350 ml. No median lobe Prostate Ca Urethral stricture Bacterial prostatitis Urinary tract infection Previous transurethral prostatic resection or bladder neck incision Dementia Bladder stones History of rectal surgery (except hemorrhoidectomy) Invasive rectal pathology (invasive Ca) Neurological disorders that might affect bladder function Neurogenic bladder dysfunction Use of drugs influencing bladder function Previous use of finasteride REFERENCES 1. Devonec, M., Berger, N. and Pemn, P.: Transurethral micro- wave heating of the prostateor from hyperthermia to ther- motherapy. J . Endourol., 5 129, 1991. 2. de la Rosette, J. J. M. C. H., de Wildt, M. J. A. M., Hofner, K., Carter, S. St. C., Debruyne, F. M. J . and Tubaro, A,: High energy thermotherapy in the treatment of benign prostatic hyperplasia: results of the European benign prostatic hyper- plasia study group. J. Urol., 156 97, 1996. 3. de la Rosette, J. J . M. C. H., de Wildt, M. J. A. M., Hofner, K., Carter, S. St. C., Debruyne, F. M. J. and Tubaro, A,: Pressure- flow study analyses in patients treated with high energy ther- motherapy. J. Urol., 156 1428, 1996. 4. Javle, P., Blair, M., Palmer, M., Jenkins, S. A. and Parsons, K. F.: The role of an advanced thermotherapy device in pros- tatic voiding dysfunction. Brit. J. Urol., 78: 391, 1996. 5. Mauroy, B., Chive, M., Stefaniak, X., Demetriou, D., Prevost, B., Hattab, B., Sozanski, J. P., Carpentier, B., Biserte, J. and Mazeman, E.: Study of the effects of thermotherapy in benign prostatic hypertrophy. Eur. Urol., 32: 198, 1997. 6. Blute, M.: Transurethral microwave thermotherapy: refining treatment strategy for benign prostatic hyperplasia. Curr. Opin. Urol., 6 14, 1996. 7. Larson, T. R. and Collins, J. M.: Increased prostatic blood flow in response to microwave thermal treatment: preliminary find- ings in two patients with benign prostatic hyperplasia. Urol- ogy, 46 584, 1995. 8. Devonec, M., Ogden, C., Perrin, P. and Carter, S. St. C.: Clinical response to transurethral microwave thermotherapy is ther- mal dose dependent. Eur. Urol., 23 267, 1993. 9. Larson, T. R., Bostwick, D. G. and Corica, A.: Temperature- correlated histopathologic changes following microwave ther- moablation of obstructive tissue in patients with benign pros- tatic hyperplasia. Urology, 47: 463, 1996. 10. Bolmsjo, M., Wagrell, L., Hallin, A,, Eliasson, T., Erlandsson, B.-E. and Mattiasson, A.: The heat is on-but how? A compar- ison of TUMT devices. Brit. J . Urol., 78: 564, 1996. 11. Eliasson, T. U., Abramsson, L. B., Pettersson, G. T. and Damber, J.-E.: Responders and non-responders to treatment of benign prostatic hyperplasia with transurethral microwave thermo- therapy. Scand. J. Urol. Nephrol., 29 183, 1995. 12. Eliasson, T. U., Abramsson, L. B., Pettersson, G. T. and Damber, J.-E.: Sexual function before and after transurethral micro- wave thermotherapy for benign prostatic hyperplasia. Scand. J. Urol. Nephrol., 30 99, 1996. 13. Chive, M.: Use of microwave radiometry for hyperthermia mon- itoring and as a basis for thermal dosimetry. In: Methods of Hyperthermia Control. Clinical Thermology Series. Edited by M. Gautherie. Berlin: Springer-Verlag, pp. 113-128, 1990. 14. Eliasson, T., Terio, H. and Damber, J.-E.: Transurethral micro- wave thermotherapy for benign prostatic hyperplasia- experience with the Prostcare. World J. Urol., 16 109, 1998. 15. Eliasson, T., Abramsson, L. and Damber, J.-E.: Importance of thermal dose and antenna localization in transurethral micro- 16. 17. 18. 19 wave thermotherapy for benign prostatic hyperplasia. J. En- dourol., in press. Huskisson, E. C.: Measurement of pain. J. Rheumatol., 9 768, 1982. Norusis, M. J.: SPSS for Windows. Chicago: SPSS Inc., 1993. Francisca, E. A. E., d'Ancona, F. C. H., Hendriks, J. C. M., Kiemeney, L. A. L. M., Debruyne, F. M. J. and de la Rosette, J. J. M. C. H.: Quality of life assessment in patients treated with lower energy thermotherapy (ProstasoR 2.0): results of a randomized transurethral microwave thermotherapy versus sham study. J. Urol., 158 1839, 1997. McConnell, J. D., Barry, M. J., Bruskewitz, R. C., Bueschen, A. J., Denton, S. E., Holtgrewe, H. L., Lange, J. L., Mcclennan, B. L., Mebust, W. K., Reilly, N. J., Roberts, R. G., Sacks, S. A. and Wasson, J. H.: Benign Prostatic Hyperplasia: Diagno- sis and Treatment. Clinical Practice Guidelines, No. 8, Publi- cation 94-0582. Rockville, Maryland: U.S. Department of Health and Human Services, Agency for Health Care Policy and Research, 1994. EDITORIAL COMMENT The authors report the initial results of transurethral thermother- apy with a Prostcare device, and a noninvasive intraprostatic radio- metric temperature measurement. In addition, they introduce the concept of a heat shock strategy. Previously to obtain appropriate intraprostatic temperatures, that is greater than 45C, microwave energy was applied incrementally and slowly. The authors maintain that a rapid attainment of high intraprostatic temperatures may induce small blood vessel thrombosis, and an alteration in neuro- muscular elements that will lessen discomfort and enhance volume heating of the transition zone adenoma. This concept is intriguing and leads to the potential consideration of altering treatment strat- egies, particularly in terms of length of sessions. If high tempera- tures can be quickly reached deep within prostate adenoma, then it is possible that the length of treatment sessions may be reduced. However, questions regarding patient tolerance largely shape this issue. The data suggest that high energy thermotherapy and a heat shock strategy produce slightly greater morbidity, and a certain number of prostatic urethras demonstrate cavity formation. The 87% urinary retention rate is certainly in the range of that of other so-called high energy protocols that produce tissue slough- ing. Mean peak flow rates and symptom score improvements are only incrementally better than those of the reported low energy protocol, thus, leading to the question of whether incremental improvement in symptom score and peak flow rate is worth the morbidity and decreased tolerability of the treatment. Significant volume heating of adenoma that produces coagulation necrosis will result in high initial response rates and durability of trans- urethral thermotherapy. However, the concept of minimally inva- sive thermotherapy embodied by transurethral thermotherapy is to produce significant reduction in symptoms related to bladder outlet obstruction caused by BPH. Only debulking procedures will

EDITORIAL COMMENT

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HEAT SHOCK HIGH ENERGY MICROWAVE THERMOTHERAPY FOR BENIGN PROSTATIC HYF'ERPLASIA

APPENDIX: INCLUSION AND EXCLUSION CRITERIA FOR TRANSURETHRAL MICROWAVE THERMOTHERAPY

781

Inclusion Criteria Exclusion Criteria Prostate vol. 25-70 ml. Madsen score 8 or greater Maximum flow rate 15 ml./sec. o r less Residual urine vol. less than 350 ml. No median lobe

Prostate Ca Urethral stricture Bacterial prostatitis Urinary tract infection Previous transurethral prostatic resection or bladder neck incision Dementia Bladder stones History of rectal surgery (except hemorrhoidectomy) Invasive rectal pathology (invasive Ca) Neurological disorders that might affect bladder function Neurogenic bladder dysfunction Use of drugs influencing bladder function Previous use of finasteride

REFERENCES

1. Devonec, M., Berger, N. and Pemn, P.: Transurethral micro- wave heating of the p r o s t a t e o r from hyperthermia to ther- motherapy. J . Endourol., 5 129, 1991.

2. de la Rosette, J. J . M. C. H., de Wildt, M. J . A. M., Hofner, K., Carter, S. St. C., Debruyne, F. M. J . and Tubaro, A,: High energy thermotherapy in the treatment of benign prostatic hyperplasia: results of the European benign prostatic hyper- plasia study group. J . Urol., 156 97, 1996.

3. de la Rosette, J. J . M. C. H., de Wildt, M. J. A. M., Hofner, K., Carter, S. St. C., Debruyne, F. M. J . and Tubaro, A,: Pressure- flow study analyses in patients treated with high energy ther- motherapy. J . Urol., 156 1428, 1996.

4. Javle, P., Blair, M., Palmer, M., Jenkins, S. A. and Parsons, K. F.: The role of an advanced thermotherapy device in pros- tatic voiding dysfunction. Brit. J. Urol., 78: 391, 1996.

5. Mauroy, B., Chive, M., Stefaniak, X., Demetriou, D., Prevost, B., Hattab, B., Sozanski, J. P., Carpentier, B., Biserte, J . and Mazeman, E.: Study of the effects of thermotherapy in benign prostatic hypertrophy. Eur. Urol., 32: 198, 1997.

6. Blute, M.: Transurethral microwave thermotherapy: refining treatment strategy for benign prostatic hyperplasia. Curr. Opin. Urol., 6 14, 1996.

7. Larson, T. R. and Collins, J. M.: Increased prostatic blood flow in response to microwave thermal treatment: preliminary find- ings in two patients with benign prostatic hyperplasia. Urol- ogy, 4 6 584, 1995.

8. Devonec, M., Ogden, C., Perrin, P. and Carter, S. St. C.: Clinical response to transurethral microwave thermotherapy is ther- mal dose dependent. Eur. Urol., 2 3 267, 1993.

9. Larson, T. R., Bostwick, D. G. and Corica, A.: Temperature- correlated histopathologic changes following microwave ther- moablation of obstructive tissue in patients with benign pros- tatic hyperplasia. Urology, 47: 463, 1996.

10. Bolmsjo, M., Wagrell, L., Hallin, A,, Eliasson, T., Erlandsson, B.-E. and Mattiasson, A.: The heat is on-but how? A compar- ison of TUMT devices. Brit. J . Urol., 78: 564, 1996.

11. Eliasson, T. U., Abramsson, L. B., Pettersson, G. T. and Damber, J.-E.: Responders and non-responders to treatment of benign prostatic hyperplasia with transurethral microwave thermo- therapy. Scand. J . Urol. Nephrol., 2 9 183, 1995.

12. Eliasson, T. U., Abramsson, L. B., Pettersson, G. T. and Damber, J.-E.: Sexual function before and after transurethral micro- wave thermotherapy for benign prostatic hyperplasia. Scand. J. Urol. Nephrol., 3 0 99, 1996.

13. Chive, M.: Use of microwave radiometry for hyperthermia mon- itoring and as a basis for thermal dosimetry. In: Methods of Hyperthermia Control. Clinical Thermology Series. Edited by M. Gautherie. Berlin: Springer-Verlag, pp. 113-128, 1990.

14. Eliasson, T., Terio, H. and Damber, J.-E.: Transurethral micro- wave thermotherapy for benign prostatic hyperplasia- experience with the Prostcare. World J. Urol., 16 109, 1998.

15. Eliasson, T., Abramsson, L. and Damber, J.-E.: Importance of thermal dose and antenna localization in transurethral micro-

16.

17. 18.

19

wave thermotherapy for benign prostatic hyperplasia. J. En- dourol., in press.

Huskisson, E. C.: Measurement of pain. J . Rheumatol., 9 768, 1982.

Norusis, M. J.: SPSS for Windows. Chicago: SPSS Inc., 1993. Francisca, E. A. E., d'Ancona, F. C. H., Hendriks, J. C. M.,

Kiemeney, L. A. L. M., Debruyne, F. M. J . and de la Rosette, J . J. M. C. H.: Quality of life assessment in patients treated with lower energy thermotherapy (ProstasoR 2.0): results of a randomized transurethral microwave thermotherapy versus sham study. J . Urol., 158 1839, 1997.

McConnell, J. D., Barry, M. J. , Bruskewitz, R. C., Bueschen, A. J. , Denton, S. E., Holtgrewe, H. L., Lange, J. L., Mcclennan, B. L., Mebust, W. K., Reilly, N. J., Roberts, R. G., Sacks, S. A. and Wasson, J. H.: Benign Prostatic Hyperplasia: Diagno- sis and Treatment. Clinical Practice Guidelines, No. 8, Publi- cation 94-0582. Rockville, Maryland: U.S. Department of Health and Human Services, Agency for Health Care Policy and Research, 1994.

EDITORIAL COMMENT

The authors report the initial results of transurethral thermother- apy with a Prostcare device, and a noninvasive intraprostatic radio- metric temperature measurement. In addition, they introduce the concept of a heat shock strategy. Previously to obtain appropriate intraprostatic temperatures, that is greater than 45C, microwave energy was applied incrementally and slowly. The authors maintain that a rapid attainment of high intraprostatic temperatures may induce small blood vessel thrombosis, and an alteration in neuro- muscular elements that will lessen discomfort and enhance volume heating of the transition zone adenoma. This concept is intriguing and leads to the potential consideration of altering treatment strat- egies, particularly in terms of length of sessions. If high tempera- tures can be quickly reached deep within prostate adenoma, then i t is possible that the length of treatment sessions may be reduced. However, questions regarding patient tolerance largely shape this issue.

The data suggest tha t high energy thermotherapy and a heat shock strategy produce slightly greater morbidity, and a certain number of prostatic urethras demonstrate cavity formation. The 87% urinary retention ra te is certainly in the range of t ha t of other so-called high energy protocols that produce tissue slough- ing. Mean peak flow rates and symptom score improvements are only incrementally better t han those of the reported low energy protocol, thus, leading to the question of whether incremental improvement in symptom score and peak flow ra te is worth the morbidity and decreased tolerability of the treatment. Significant volume heating of adenoma tha t produces coagulation necrosis will result in high initial response rates and durability of trans- urethral thermotherapy. However, the concept of minimally inva- sive thermotherapy embodied by transurethral thermotherapy is to produce significant reduction in symptoms related to bladder outlet obstruction caused by BPH. Only debulking procedures will

782 HEAT SHOCK HIGH ENERGY MICROWAVE THERMOTHEWY FOR BENIGN PROSTATIC HYPERPLASIA

attain the flow rate improvement seen with transurethral resec- tion of the prostate. Transurethral thermotherapy that produces debulking results in surgical morbidity, decreased tolerability and a need for sedative analgesia.

If tolerability is improved and morbidity is lessened, minimally invasive therapy need not have the same effectiveness as transure- thral resection of the prostate to be a successful BPH management strategy. In my opinion the goal of transurethral thermotherapy

should not be debulking, which should be reserved for surgical op- tions. The goal of significant symptom reduction with no need for anesthesia and risk of surgical morbidity is an achievable goal for transurethral thermotherapy.

Michael L. Blute Department of Urology Mayo Clinic Rochester, Minnesota