The Hytrin Community Assessment Trial study: a one-year study of terazosin versus placebo in the treatment of men with symptomatic benign prostatic hyperplasia. HYCAT Investigator Group.

OBJECTIVES: To determine the clinical effectiveness and safety of alpha(1)-blockade therapy versus placebo in the treatment of men with moderate to severe symptoms of prostatism in a community-based population under usual care conditions. METHODS: The Hytrin Community Assessment Trial is a prospective, placebo-controlled, randomized, double-blinded, 1-year clinical trial, conducted at 15 academic medical centers (regional sites) and 141 private urology practices (satellite sites). A total of 2084 men at least 55 years old with moderate to severe symptoms of benign prostatic hyperplasia (BPH) as determined by an American Urological Association (AUA) Symptom Score (AUA-SS) of 13 or more points and a bother score (AUA-BS) of 8 or more were enrolled. Randomized patients at regional sites were required to have a peak urinary flow rate less that 15 mL/s with voided volume of at least 150 mL. Treatment with terazosin was initiated with 1 mg daily for 3 days, followed by 2 mg daily for 25 days. Thereafter, patients were titrated stepwise to 5 or 10 mg if they failed to achieve a 35% or greater improvement in the AUA-SS. Primary outcome measures were AUA-SS, AUA-BS, BPH Impact Index (BII), disease-specific quality of life (QQL) score, and treatment failure as defined as discontinuation due to persistent or worsening symptoms or need for surgical intervention for BPH. Secondary outcome measures were peak urinary flow rate and postvoid residual urine volume. RESULTS: AUA-SS (0 to 35 point scale) improved from a baseline mean of 20.1 points by 37.8% during terazosin (n=976) and by 18.4% during placebo (n=973) treatment (P<0.001). Similarly, statistically superior improvements were observed in regard to the AUA-BS, BII, and the QQL score in the terazosin-treated patients. Peak urinary flow rate improved from a baseline of 9.6 mL/s (both regional treatment groups) by 2.2 mL/s in the terazosin group (n=137) and by 0.7 mL/s in the placebo group (n=140) (P< or = 0.05). Treatment failure occurred in 11.2% of terazosin- and 25.4% of placebo-treated patients (P<0.001; Kaplan-Meier adjusted withdrawal rates of 365 days). Withdrawal from study drug treatment due to adverse events occurred in 19.7% of terazosin- and 15.2% of placebo-treated patients (P<0.001). CONCLUSIONS: Terazosin given once daily in a dose ranging from 2 to 10 mg in community-based urology practices under conditions simulating usual care is effective in reducing the symptoms, perception of bother, and the impairment of QQL due to urinary symptoms in men with moderate to severe symptoms of prostatism. This effect is superior to placebo and maintained over 12 months of follow-up. Clinical research outcome studies in BPH can be conducted in community-based practices, thus simulating as closely as possible "usual care" conditions.

A comparative assessment of cryosurgical devices: application to prostatic disease.

OBJECTIVES: To determine the comparative freezing ability of the Cryotech (CT) and AccuProbe (CMS) cryosurgical systems. METHODS: Four conditions designed to model clinical situations were produced: (1) Single-probe performance in water at 17 degrees C; (2) five-probe performance in water at 17 degrees C; (3) single-probe performance in gel at 22 degrees C; and (4) single-probe performance in bovine liver. Parameters evaluated included temperatures at various time points (rates to and final low temperature), configuration of a freeze zone, and shaft freezing characteristics. In addition, isotherms were measured at predetermined distances from the center of the freeze zone. RESULTS: Both systems provided freezing of various media under operational conditions. In water, the CMS 3-mm probe delivered more rapid freezing temperature rates than the 3-mm CT probe, with a 110 degrees C difference in probe surface temperature. In gel, the CMS probe increased freeze volume fourfold versus a twofold increase for the CT probe. In bovine liver, there was nearly equivalent performance with respect to geometry of the freeze ball. Extrapolation of the CT cooling curve indicated temperature equivalence at 30 minutes. A larger shaft diameter 4.9-mm CT probe produced results similar to the CMS probe in all the tested media. In addition, the freeze configuration of the CMS probe was spherical; the CT configuration was more cylindrical. CMS probe (equivalent diameter) tip temperatures were on average 100 degrees C lower. CONCLUSIONS: Our tests demonstrated differences between the CMS and CT probe. The major differences are in the configuration of the freeze zone and shaft freezing. In equivalent conditions, the CMS 3-mm probe delivered more rapid cooling rates, a more spherical freeze ball, and lower absolute temperatures than the CT 3-mm probe. The larger CT probe produces equivalent freezing temperatures to the CMS probe, albeit with a more spherical shape. However, these in vitro systems may not adequately reflect varied prostate morphology. Further research is under way to determine if these differences affect relative efficacy of cryotherapy of the prostate.

Persistence or recurrence of symptoms after transurethral resection of the prostate: a urodynamic assessment.

Approximately 15 to 20% of patients who undergo transurethral resection of the prostate for benign prostatic hyperplasia have persistent or recurrent voiding symptoms requiring further therapy. To elucidate the etiology of these voiding abnormalities, the urodynamic findings of 129 consecutive men (mean age 72 years) with post-transurethral resection voiding symptoms were retrospectively analyzed with respect to symptoms, uroflowmetry and synchronous video pressure-flow cystometry. Our findings revealed obstruction in 38% of the patients, impaired contractility in 25% and intrinsic sphincter deficiency in 8%. Among 80 patients without neurological disorders involuntary bladder contractions were detected in 50%. However, in 49 patients with neurological disorders involuntary bladder contractions were detected in 76%. This difference was statistically significant. There were 15 patients who failed 2 or more transurethral resections of the prostate, and involuntary bladder contractions were detected in 80%, obstruction in 27%, impaired contractility in 27% and sphincteric incontinence in 20%. Our study reveals residual or recurrent obstruction to be a contributing factor in less than half of all patients who fail transurethral resection of the prostate. Furthermore, patients with a concomitant neurological disorder and those who have undergone more than 1 transurethral resection of the prostate have a significantly higher incidence of involuntary bladder contractions. These results underscore the importance of obtaining complete urodynamic assessment in patients with persistent or recurrent voiding symptoms following transurethral resection of the prostate to guide appropriate therapy.