16

8.

9.

1.

2.

3.

4.

5.

6.

7.

8.

9.

TREATMENT OUTCOME OF BENIGN PROSTATIC HYPERPLASIA

0 = no, 1 = mild, 2 = moderate, 3 = severe,

Nocturia 0 = 0 to 1, 1 = 2, 2 = 3 to 4, 3 = greater than 4 Diuria 0 = less than every 3 hours, 1 = less than once every 2

hours and up to every 3 hours, 2 = less than once an hour and up to every 2 hours, 3 = once an hour or more

(incontinent)

APPENDIX 2: BOTHER FROM GENITOURINARY DIFFICULTIES

’ Overall, how bothersome has your trouble with urina- tion been?

1 = bother me a lot or bothers me some 0 = bothers me a little or not bothersome a t all In general, has your urinary problem interfered with

1 = yes, a lot or some 0 = very little or no, not at all In general, has your urinary problem interfered with

your normal social activity? 1 = yes, a lot or some 0 = very little or no, not a t all Have you ever had to urinate without being able to con-

1 = yes, a t least once or twice a month 0 = no, never Have you ever wet your pants? 1 = yes, at least once or twice a month 0 = no, never Over the past month how much have the following been

Dripping urine or wetting your pants 1 = very small to big problem 0 = no problem Feeling uncomfortably full in your bladder 1 = very small to big problem 0 = no problem Worry that you would block up and not be able to uri-

nate a t all 1 = very small to big problem 0 = no problem Concern about being too far away from a bathroom 1 = very small to big problem 0 = no Droblem

your normal physical activity?

trol it?

problems for you?

10. Embarrassment about having to go to a bathroom too oRen

1 = very small to big problem 0 = no problem

11. Over the past 2 or 3 months or so, would you say your urinary difficulties have gotten worse, better or stayed the same?

1 = gotten a little or much worse 0 = gotten much or a little better, or stayed about the

Scores are summed and then scaled so that the maximum same

is 100.

REFERENCES

1. Wasson, J. H., M a , D. J., Bruskewitz, R. C., Elinson, J., Keller, A. M., Henderson, W. G., and the Veterans Affairs Cooperative Study Group on Transurethral Resection of the Prostate: A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. New. Engl. J. Med., 332: 75, 1995.

2. The Department of Veterans Affairs Cooperative Study of trans- urethral resection for benign prostatic hyperplasia: A compar- ison of quality of life with patient reported symptoms and objective findings in men with benign prostatic hyperplasia. J. Urol., part 2, 1iW 1696, 1993.

3. Woolson, R. F.: Statistical Methods for the Analysis of Biomed- ical Data. New York John Wiley, 1987.

4. Cox, D. R. and Oakes, D.: Analysis of Survival Data. London: Chapman and Hall, 1984.

5. Diggle, P., Liang, K. and Zeger, S.: Analysis of Longitudinal Data. Oxford: Clarendon Press, 1994.

6. SAS Institute, Inc.: SASBTAT User’s Guide, version 6, 4th ed. Cary, North Carolina: SAS Institute, 1989.

7. Barry, M. J., Fowler, F. J., Jr., Bin, L., Pitts, J . C., Jr., Harris, C. J. and Mulley, A. G., Jr.: The natural history of patients with benign prostatic hyperplasia as diagnosed by North American urologists. J . Urol., 157: 10, 1997.

8. Oesterling, J. E.: Benign prostatic hyperplasia. Medical and minimally invasive treatment options. New. Engl. J . Med., 332 99, 1995.

9. Bruskewitz, R. C., Reda, D. J., Wasson, J. H., Barrett, L. and Phelan, M.: Testing to predict outcome after transurethral resection of prostate. J. Urol., 157: 1304, 1997.

10. Andersen, J. T., Nickel, J. C., Marshall, V. R., Schulman, C. C. and Boyle, P.: Finasteride significantly reduces acute urinary retention and need for surgery in patients with symptomatic benign prostatic hyperplasia. Urology, 49 839, 1997.

EDITORIAL COMMENTS

This study comparing transurethral prostatic resection versus watchful waiting represents a landmark in the management of BPH. One of the challenges in the design of a long-term outcomes study is to identify appropriate end points that reflect treatment failure. In general, the options are to establish an absolute or percentage change in the primary outcomes measures that represents treatment failure. Two end points for treatment failure in this study were a post-void residual of 350 cc and a symptom score greater than 24. According to this definition of treatment failure, a subject with a baseline post-void residual of 50 cc who then has a post-void residual of 340 cc would not be considered a treatment failure, whereas a subject with a baseline post-void residual of 340 cc who then has a post-void residual of 350 cc would be considered a treatment failure. Similarly, a subject with a baseline symptom score of 13 who then has a symptom score of 20 would not be considered a treatment failure, whereas a subject with a baseline symptom score of 23 who then has a symptom score of 25 would be considered a treatment failure. Since the primary reasons for treatment failures in this study were symptom score and post-void residual progression, the progression rates may reflect subjects experiencing slight and insig- nificant changes in study end points. More information about the failures would have been of interest. Although the present study provides a wealth of information, personally, I was a bit disappointed by the limited extent of the data analysis and the implications related to the natural history and surgical management of BPH.

The data provide insights into the natural history of BPH as it relates to the development of urinary retention. Only 3.6% of the men in the watchful waiting arm had urinary retention, which is considerably less than the urinary retention rates reported in the placebo group of the PLESS study. This finding is somewhat unex- pected since the watchful waiting group in the present study appears to have more severe symptoms, lower urinary flow rates and larger post-void residual urine volumes than the placebo arm of the PLESS study. The men in the placebo group in the PLESS study had larger prostates. A comparison of urinary retention rates in the aforemen- tioned watchful waiting and placebo groups suggests that prostate size is likely a significant predisposition for the development of urinary retention.

Herbert Lepor Department of Urology New York University Medical Center New York, New York

This study comparing watchful waiting and transurethral resec- tion of the prostate in men with moderate symptoms of BPH gives us a unique insight into the long-term outcomes of both treatment strategies for patients suffering from this common condition. In addition, we gain insight into what triggers patient decision for or against invasive surgical treatment. In this most recent update the authors report an average followup of 3.4 years for the transurethral prostatic resection and of 3.6 years for the watchful waiting treated patients. It is remarkable that during this, only 24% of the trans-