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CORRELATION OF SYMPTOM SCORE WITH BENIGN PROSTATIC HYPERPLASIA 679

followup in transurethral resection of the prostate using the computer program CLIM: a prospective study. J . Urol., 148: 111, 1992.

22. Neal, D. E., Ramsden, P. D., Sharples, L., Smith, A, Powell, P. H., Styles, R. A. and Webb, R. J.: Outcome of elective prostatectomy. Brit. Med. J., 299: 762, 1989.

23. Abrams, P., Blaivas, J., Nordling, J., Griffiths, D. J., Kondo, A., Koyanagi, T., Neal, D., Schafer, W. and Yalla, S. V.: The objective evaluation of bladder outlet obstruction. In: The Sec- ond International Consultation on Benign Prostatic Hyperpla- sia (BPH). Edited by A. T. K. Cockett, S. Khoury, Y. Aso, C. Chatelain, L. Denis, K. Griffiths and G. Murphy. Channel Islands: Scientific Communication International Ltd., pp. 153-209, 1993.

24. Griffiths, D., van Mastrigt, R. and Bosch, R.: Quantification of urethral resistance and bladder function during voiding, with special reference to the effects of prostate size reduction on urethral obstruction due to benign prostatic hyperplasia. Neurourol. Urodynam., 8: 17, 1989.

25. Schiifer, W., Noppeney, R., Rubben, H. and Lutzeyer, W.: The value of free flow rate and pressurdflow-studies in the routine investigation of BPH patients. Neurourol. Urodynam., 7: 219, abstract 42, 1988.

26. Abrams, P. and Griffiths, D. J.: The assessment of prostatic obstruction from mdynamic measurements and from residual urine. Brit. J. Urol., 61: 129, 1979.

27. Chancellor, M. B., Blaivas, J . G., Kaplan, S. A. and Axelrod, S.: Bladder outlet obstruction versus impaired detrusor contractility: the role of uroflow. J. Urol., 145: 810, 1991.

New York: MacMillan Publishing Co., chapt. 19, pp. 303-330, 1988.

2. Dyro, F. M., DuBeau, C. E., Sullivan, M. P., Cravalho, E. G. and Yalla, S. V.: Covert co-morbid neurologic abnormalities in patients presenting with symptoms of prostatism. J . Urol., part 2, 147: 269A, abstract 223, 1992.

3. Elbadawi, A. E., Yalla, S. V. and Resnick, N. M.: Structural basis of geriatric voiding dysfunction 11. Aging detrusor: normal versus impaired contractility. J. Urol., 160 1657, 1993.

4. Coolsaet, B. and Elbadawi, A.: Urodynamics in the management of benign prostatic hypertrophy. World J . Urol., 6 215, 1989.

5. Boyarksy, S., Jones, G., Paulson, D. F. and Prout, G. R., Jr.: A new look at bladder neck obstruction by the Food and Drug Administration regulators: guidelines for investigation of benign prostatic hypertrophy. Trans. Amer. Ass. Genito-Uh. Surg., 68 29, 1977.

6. Madsen, P. 0. and Iversen, P.: A point system for selecting operative candidates. In: Benign Prostatic Hypertrophy. Ed- ited by F. Hinman, Jr. and S. Boyarsky. New York Springer- Verlag, chapt. 79, pp. 763-765, 1983.

7. Fowler, F. J., Jr., Wennberg, J. E., Timothy, R. P., Barry, M. J., Mulley, A. G., Jr. and Hanley, D.: Symptom status and quality of life following prostatectomy. J.A.M.A., 259 3018, 1988.

8. O'Leary, M. P., Barry, M. J. and Fowler, F. J., Jr.: Hard measures of subjective outcomes: validating symptom indexes in urology. J. Urol., 148 1546, 1992.

9. Barry, M. J., Fowler, F. J., Jr., O'Leary, M. P., Bruskewitz, R. C., Holtgrewe, H. L., Mebust, W. K., Cockett, A. T. K. and The Measuring Committee of the American Urological Association: The American Urological Association symptom index for benign prostatic hyperplasia. J. Urol., 148 1549, 1992.

10. The International Prostate Symptom Score (I-PSS) and Quality of Life Assessment. In: The 2nd International Consultation of Benign Prostatic Hyperplasia (BpH), paris, June 27-30, 1993. Jersey, Channel Islands: Scientific Communication Interna- tional, Ltd. pp. 554455, 1993.

11. McConnell, J. D., Bany, M, J., Bruskewitz, R. c., et al.: ~ ~ n i ~ prostatic hyperplasia: diagnosis and treatment. Quick Ref- erence Guide for Cli,y,cians. Rockville, Agency for Health care policy and public ~ d t h states Department ofHealth and H~ services, m c p ~ pub- lication No. 94-0583, February, 1994.

12. Sullivan, M. P. and Yalla, S. V.: Urodynamic assessment of benign prostatic hypertrophy. In: Alternate Methods in the Treatment of Benign Prostatic Hyperplasia. Edited by N. A. Romas and E. D. Vaughan, Jr. New York Springer-Verlag, pp. 66-89, 1993.

13. Y a a , s. v. and B ~ & ~ , H,: ~h~~~ ofthe spa cod affecting the urinary tract, ~ n : clinical urography. Edited by H. M. Pollack. Philadelphia: W. B. Saunders Co., pp. 2017-2025,1989.

14. Yalla, S. V., Cravalho, E., Resnick, N., Chiang, R., Gilliam, J. and Brown, K.: ~ l ~ ~ t i ~ jump in male during voiding:

studies in dogs. J. Urol., 134: 907, 1985.

15. yalla, s. v,, Shams, G. v. R. K. and mi^, E. M.: w c ~ - tional static profile: a method of recording urethral pressure profile during voiding and the implications. J. Urol., 124: 649, 1980.

16. Yalla, S. V., Blute, R., Waters, W. B., Snyder, H. and Fraser, L.: Ur0dyn-c evaluation of prostatic enlargements with micturitional vesicourethal static press- profiles. J. urol., 125 685,1981.

17. Yalla, S. V., Cravalho, E., Resnick, N. M. and Chiang, R.: Ex- perimental studies with total and static uTethral pressures in canine urethra and their significance. ~ ~ ~ ~ ~ l . urodynam., 6 439, 1988.

18. Desmond, A. D. and Ramayya, G. R.: Comparison of pressurd flow studies with micturitional urethral pressure profiles in the diagnosis of urinary outflow obstruction. Brit. J. Urol., 61:

EDITORIAL COMMENTS

This article Presents several interesting hdings. First, among consecutive men with prostatism referred for urodynamies, a careful history and Physical e x e a t i o n Were able to Patients into 2 groups with different probabilities of physiological obstruction. Men without co-morbidities had physiological obstruction 80% of the time, while men with co-morbidities raising the probability of alternate diagnoses had Obstlvdion only 58% Of the time. This finding supports the importance of a Careful clinical assessment of such patients, as recommended by the recently released BPH guidelines. Presumably, however, there were reasons these men were referred for WOdyn-Cs, Which may make them different from ConSe~tiVe men seen in a general urological Setting.

Moreover, amOng both groupS W P b m levels as measured with the AuA index could not te between men with and without obstruction, or for that matter, between men with and without detrusor overactivity. Separathg the index into obstructive and irritative sub- scales did no better. While time honored, the d i 6 o n of lower urinary tract Symptoms *to Obstructive and irritative -PS aPpearS invalid and PmbablY should be abandoned.

Assuming that men with neurological co-morbidities or residual symptoms after treatment are more likely to benefit from physiological study, should full urodynamics be recommended for men without clinical evidence of problems other than BPH? Two types of studies are needed to answer this question. To prove reliable results can be obtained outside of a few specialty centers, a group of community urnlogists should be trained to perform the various tests and a group of older men with lower urinary tract Symptom Should be examined twice a few days apart, with different blinded examiners. The test (if my) that yields the most reliable results can then be used in a clinical trial to determine whether patient outcomes are improved at reasodde cost with routine urodyn-c Study compared to care. Such a study would have to be large, since any improvement in outcomes for men without co-morbidities would be generated by offering (presumably) more effective treatment for only 1 of 5 men Who Proved not to have PhYsiolO@cal obstruction.

observations in male subjects and

Michael J. Barry Medical Pmctices Eualuatwn Center

224, 1988. 19. DuBeau, C. E., Sullivan, M. P., Venegas, J. G., Resnick, N. M.

and Yalla, S. V.: Correlations between pressure-flow and micturitional urethral pressure profile parameters. J. Urol., part 2, 161: 324A, abstract 385, 1994.

20. Abrams, P., Blaivas, J. G., Stanton, S. L. and Andersen, J. T.: Standardisation of terminology of lower urinary tract function. Neurourol. Urodynam., 7: 403,1988.

21. Rollema, H. J. and van Mastrigt, R.: Improved indication and

Massachusetts Gene& Hospital Boston, Massachusetts

This carefully done study demonstrates minimal correlation between symptoms (measured by the AUA symptom index) and urodynamic obstruction (measured by micturitional urethral pressure profilometry). Previous studies have shown poor correlation amow symptoms, uroflowmetry, post-void residual urine and pressure-flow d y n a m i c studies in men with presumed BPH. Many Urodynamic

680 CORRELATION OF SYMPTOM SCORE WITH BENIGN PROSTATIC HYF'ERPLASIA

experts believe that this lack of correlation limits the value of symp tom assessment, while others argue that poor correlation calls into question the value of dynamics . Indeed, poor correlation exists between individual objective parameters, such as uroflowmetry and pressure-flow studies. Lack of correlation does not invalidate any of these measurement tools but, rather, suggests that the relationship among prostate growth, bladder function and symptoms is far more compli- cated than previously believed.

The AUA symptom index cannot be used to diagnose bladder outlet obstruction secondary to BPH. Neither the authors of the symptom score nor the AHCPR guidelines have suggested otherwise. Elderly men and women with a variety of lower urinary tract diseases may exhibit high symptom scores. The AUA symptom index was designed as an objective, reproducible tool to measure symptoms and response to therapy. It is now time to lay to rest this raging debate about symptom scores and urodynamics, and move on to the important question of whether the routine or selective performance of invasive urodynamics alters the ultimate outcome of treatment.

Patients are interested in outcomes that affect them directly, such as direct health outcomes, which include symptom improvement, incontinence, impotence, pain and discomfort. Bladder pressures and micturitional urethral pressure profile measurements (indirect or physiological outcomes) are important only to the extent that they serve as predictors of direct outcomes, for example symptom improvement. The authors suggest that patients should be informed of the failure rates of therapy in "obstructed and nonobstructed BPH so that they can appropriately participate in the treatment decision." Presently, no data in the literature suggest that the probability of a patient doing well on watchful waiting or medical therapy is at all altered by the presence or absence of urodynamic obstruction. In contrast, studies indicate a decrease in treatment failure iftransure- thral resection of the prostate is reserved for patients with obstruction. However, the probability of failure of transurethral resection of the prostate is small. In the recent multicenter Veterans Adminis- tration cooperative trial of transurethral resection of the prostate versus watchfid waiting, which did not use invasive urodynamic studies for patient selection, only 10% of the patients failed to have symptomatic improvement. Moreover, the majority of patients without urodynamic obstruction undergoing transurethral resection of the prostate enjoy symptomatic improvement.

The authors suggest that until randomized studies provide the necessary data, invasive urodynamic evaluation should be performed routinely. However, given the outcomes currently enjoyed by available treatment options, it seems more reasonable to suggest that urodynamics not be performed routinely until randomized prospective studies clearly indicate their value and cost- effectiveness.

Urodynamic obstruction is not an outcome. The urodynamic community should focus their efforts on the design of multicenter, prospective trials to define the predictive value of the tests, for example the International Continence Society trial. The standard of BPH care currently mandates that treatment options be tested in randomized clinical trials before they are unleashed on the general population. Invasive urodynamic testing should be subject to the same level of scrutiny. The ability of urodynamics to decrease the failure rate of intervention must be proved before any recommendations can be made concerning widespread use.

John D. McConnell Division of Urology Southwestern Medical School Dallas, Texas

REPLY BY AUTHORS

We would like to thank Doctors Barry and McConnell for their insightfid comments. Although most of the concerns raised in their editorial comments have already been addressed in our discussion, perhaps this reply will clarify some of these issues. Furthermore, the primary intent of our report was to determine whether any correlations exit between the AUA symptom index and obstructive BPH but not to digress into a debate on the impact of d y n a m i c s on the treatment outcomes. Nevertheless, we will respond to the issues raised.

We agree with Doctor Barry about the need to design a prospective study for determining the impact of urodynamic assessment on BPH treatment outcomes. In fact, we recently reported our results on patient perceptions of treatments predicated on the urodynamic results.' Our retrospective study of 140 patients suggests the favor- able impact of our urodynamic assessment techniques in appropri-

ately managing voiding dysfunctions. Certainly, prospective studies are needed to confirm our observations.

Regarding the patient population that was subjected to dynamics , all patients with voidmg dysfunction underwent d y n a m i c evaluation as part of mutine clinical evaluation. No selection of patients was involved. Therefore, this population would not be substantially different h m consecutive men seen in a general urological setting.

Although Doctor McConnell reminds us of the original intent of the AUA symptom index, this has already been adequately addressed in our article. However, we once again emphasize that the Patient's Guide published by the AHCPR (consumer version, clinical practice guideline number 8, page 2) clearly stated that symptoms of BPH are caused by prostatic narrowing (obstruction). This premise has con- tributed to much confusion and has fueled the continuing "raging debate." Since many clinical urologists continue to believe that symptoms are caused by obstruction as stated in these guidelines, it is important that these issues continue to be discussed until they are adequately resolved, Until now, there has been no substantial literature to support that the AUA symptom index cannot simply be equated with obstruction in patients presumed to have BPH. Al- though the question of whether urodynamics alters the outcome of treatment is reasonable and should be further examined, we would submit that the more important question is whether urodynamics can prevent unnecessary surgical interventions. In this regard, urodynamic parameters need not be "predictors of direct outcomes" but must (and do) provide objective evidence of functional abnormalities.

We have not suggested that comprehensive urodynamics be routinely performed, as implicated by Doctor McConnell. Instead, we have discussed the use of urodynamics particularly in those for whom interventional procedures are planned and also in frail, elderly subjects who are prone to adverse reactions following any form of treatment. We do not agree that morbid prone treatment options, including interventional procedures designed to relieve prostatic obstruction, should continue to be recommended without objectively establishing the presence of prostatic obstruction. This becomes more crucial in frail, elderly patients who are prone to voiding dysfunctions that may not be caused by lower urinary tract pathol- ogy. Because of the high prevalence of nonobstructive voiding dysfunction in this age group (nearly 30% in our series), unnecessary interventions on the prostate will continue if all dysfunctions in the elderly are presumed to be due to obstructive BPH. Also, there is no evidence that interventional procedures in elderly symptomatic patients with no outlet obstruction will result in better outcomes than conservative measures. As active participants of the Veterans Administration cooperative

study on BPH, including the planning (the executive committee), we would mention that the presence or absence of outlet obstruction was not addressed in this highly select patient group. Admittedly, the majority of patients improved regardless of the conduit status of the outlet. However, it does not answer whether patients without obstruction could have been more appropriately managed with conservative watchfid waiting than transurethral resection of the prostate. Notwithstanding this discussion, we reemphasize that we are less concerned if relatively benign, inexpensive pharmacological measures that yield fairly quick clinical responses are used without objective functional assessment.

The currently practiced urodynamic techniques are based on sound physical principles of fluid and muscle mechanics, and can rationally characterize the lower urinary tract function. Further- more, our own methods of micturitional urethral pressure profile for assessing outlet obstruction have been validated with animal and bench models, and supported by clinical followup. The argument to defer all rational functional assessments until we find accurate an- swers concerning the clinical validity of urodynamics can only lead to continued unnecessary interventional procedures on nonobstructive prostates and in patients whose symptoms may not even be of prostatic origin. We agree with Doctor McConnell that the standard of BPH care mandates the testing of treatment options in randomized clinical trials without the support of some form of rational, objective functional assessments can only lead to erroneous assumptions and inaccurate conclusions. Nevertheless, we believe that efforts to sim- plify and validate urodynamic methods must continue while judi- ciously using urodynamics for characterizing outlet obstruction.

1. Lecamwasam, H. S., Sullivan, M. P., Desireddi, N., Cravalho, E. G. and Yalla, S. V.: Voiding profilometry as a diagnostic aid in patients with prostatism: assessment with post therapeutic symptom evaluation. Neurourol. Urodynam., 13: 391, 1994.

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