BPH is an extremely common condition that affects most men age 55 yr and older. BPH develops almost exclusively in the periurethral and transition zone tissues within the prostate gland. The cause of BPH is not known; androgens are necessary but not sufficient to initiate and maintain subsequent growth. Histologically, hyperplastic nodules develop in part as a result of prolonged exposure of prostatic tissue to androgens (1,21). Clinical symptoms compatible with BPH are present in most men over 60 yr of age. These lower urinary tract symptoms often include obstructive symptoms such as diminished force of stream, hesitancy, and postvoid dribbling (22). Over time, these obstructive changes can lead to bladder dysfunction, with related symptoms such as urgency, straining, and urgency incontinence. In severe cases, hydronephrosis and chronic renal impairment may develop.
Urinary tract symptoms and urinary flow rates tend to worsen over time, although there is not a direct correlation between an individual's prostate size and his symptoms (23). This is logical because a patient may have profound enlargement of the transition zone without accompanying urethral obstruction. Conversely, obstruction is seen in some men without much overall change in their prostate volume. The topographic arrangement and possibly the capsular tone of the gland seem to be more important than the actual prostate volume in determining onset of secondary urinary tract symptoms.
Three clinical parameters that are commonly measured in patients with BPH at baseline and after initiation of treatment include prostate size, urinary flow rate, and symptom scores. Prostate size and flow rate are objective variables that can be readily assessed by the physician during routine office visits. Patient symptom scores and other questionnaires are also widely used to delineate symptoms. Many of these are modified versions of the symptom index survey designed by Boyarsky and associates (24). Obtaining baseline measurements before initiating therapy allows longitudinal tracking of specific symptoms. The decision to actively treat the patient is often based on the degree of bother that the patient experiences. As described in the following section, these symptom questionnaires are an important component of patient follow-
up and have been routinely used in finasteride clinical trials, along with assessment of change in prostate size and uroflow rate.
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