A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of terazosin in the treatment of benign prostatic hyperplasia.

OBJECTIVES: This study was designed to evaluate the safety and efficacy of the selective alpha 1-adrenoceptor blocker terazosin in the treatment of benign prostatic hyperplasia (BPH). METHODS: Two hundred twenty-four patients aged 50 to 80 years, who had a diagnosis of BPH based on medical history, physical examination, and digital palpation, were recruited from 11 different sites between January 1992 and January 1994. The study consisted of a screening phase, a placebo phase, a double-blind dose-titration phase, and a double-blind maintenance phase. RESULTS: Of the patients recruited, 164 entered the double-blind phase and of these 134 were evaluable. Only 11 patients withdrew because of an adverse event, 7 in the terazosin and 4 in the placebo group. Compared to placebo, terazosin significantly increased peak and mean urine flow rates without significantly affecting voided volume or postvoid residual volume. It significantly improved both the obstructive and irritative symptoms associated with BPH. Fifty-one patients from the terazosin group reported a total of 120 adverse events compared with 83 reported by 42 patients in the placebo group. The majority of these events were mild to moderate. Seventeen terazosin-treated patients reported hypotension-related adverse events and 4 withdrew from the study. However, concurrent treatment with antihypertensive agents did not affect the blood pressure response of the terazosin group. CONCLUSIONS: Overall, this study showed terazosin to be safe and effective in relieving the signs and symptoms of BPH and should be considered as a treatment alternative.

Safety and efficacy of high kV biliary lithotripsy: preliminary experience.

Despite intense interest in laparoscopic cholecystectomy, biliary lithotripsy (BL), by avoiding the need for general anesthesia, could remain a useful alternative in approximately 10% of patients with symptomatic gallstones. The poor stone clearance rates reported by the Dornier National Biliary Lithotripsy Study has led to disenchantment with biliary lithotripsy. However, the results may reflect the relatively low kV (18.7 +/- 1.7) used. We have compared symptomatic gallbladder stone/cholecystolithiasis patients with one to five stones of aggregate diameter < 60 mm treated with one to three sessions on an MPLS 9000 (Dornier) lithotripter at moderate kV (22.7 +/- 1.7 kV; mean number of shocks 1473 +/- 356) with a similar group treated with high kV (26 kV, mean number of shocks 1357 +/- 507). Ultrasound stone diameter measurements were made pre- and post-BL; 12-wk results are reported. Treatment safety was assessed by recording adverse experiences and serum, urine, hematology, and chemistry. For patients with single stones, the high kV treatment took significantly (p < 0.05) less time (74 +/- 30 min) than moderate kV treatment (118 +/- 33 min). At 3 months, the moderate kV-treated single-stone group had a residual maximum fragment size of 3.2 +/- 3.3 mm versus 1.8 +/- 2.3 mm in the high kV-treated single-stone group. The 3-month stone-free rate for patients with single stones treated at high kV was 44% compared with 46% for the moderate kV-treated group (NS). At 1 wk, 11 patients had microscopic or macroscopic hematuria and six patients had mildly elevated liver function tests. At 6 wk, however, all urine and hematological measurements had returned to normal. Two patients suffered pancreatitis, one in each group. High kV BL appears to be safe and, for patients with single stones, gives better fragmentation and takes less time to administer than moderate kV. Whether a high kV treatment protocol can achieve improved long-term stone-free rates remains to be assessed.

Optimizing gallbladder stone lithotripsy: an international survey.

Rates of stone clearance with extracorporeal shock wave cholecystolithotripsy (biliary lithotripsy [BL]) initially reported by European groups were encouraging. An American multicenter BL study (the Dornier National Biliary Lithotripsy Study [DNBLS]) did not reproduce these results. The BL treatment strategies and 6-month stone clearance rates of six leading European and Japanese centers were compared with those of DNBLS. All foreign centers used adjuvant oral chemolitholysis and greater shock wave energies from the same lithotriptor as that in DNBLS. Six months after BL, the stone clearance rates at all six centers were higher than those of DNBLS. There were no significant differences in complication rates between centers. These findings suggest that the poor results of DNBLS were chiefly due to the use of low kilovoltage and few BL sessions. Increased energy levels and a fragment size end point of less than 5 mm optimize BL. Despite the popularity of laparoscopic cholecystectomy, BL can be recognized as a successful treatment alternative for patients with a low burden of radiolucent stones.

The Koch pouch: radiographic evaluation of the orthotopic and cutaneous forms.

The Koch pouch is a continent ileal reservoir. It has several advantages over the standard ileal conduit. The pouch can be attached to the skin (cutaneous type) or the male urethra (orthotopic type). Both variations have special imaging considerations. The suggested imaging protocol is based upon experience with 47 patients (22 with orthotopic and 25 with cutaneous pouches). The normal appearance of the new and mature pouch and its complications and their management are presented.

Kock to urethra: continent functional bladder replacement.

Since 1950 when Bricker first described the construction of the ileal conduit, this procedure has become a standard method of urinary diversion after pelvic exenteration. Recently, increasing interest in continent diversions has resulted in the development of several new procedures, using both small bowel and large bowel to produce and internal urinary reservoir. Such reservoirs still maintain a urinary stoma which requires periodic catheterization for emptying. With the development of the Kock low-pressure urinary reservoir, it has now become possible to re-establish the continuity of the urinary system by anastomosing this internal reservoir to the posterior urethra. This procedure utilizes the distal urethral sphincter as a continence mechanism and allows functional bladder emptying without a stoma. An antireflex valve is constructed to protect the kidneys. The authors report their experience with 20 such diversions, describing the operative technique, detailing the perioperative complications and providing urodynamic evidence of restored bladder function.

Estrogen and progesterone binding sites in renal cell carcinoma.

Twenty-five renal cell carcinomas were assayed for estrogen and progesterone receptor levels. Estrogen specific binding was present in only 4 patients (16%) and progesterone specific binding in 7 patients (28%). In all cases these receptors were present in very low titers, less than 10 fm/mg. We believe that earlier reports citing significant estrogen and progesterone binding activity may reflect high levels of nonspecific protein binding.

Urinary diversion using the Kock ileal reservoir in patients with irradiated bowel.

The creation of a Kock ileal reservoir is the most common method of continent urinary diversion. The procedure utilizes a metre of distal small bowel. Preoperative pelvic irradiation in patients who are to undergo radical cystectomy for invasive bladder cancer frequently results in thickening of the bowel and its mesentery. This change makes construction of the Kock reservoir somewhat more difficult and could theoretically increase the potential for complications. The authors have found, in a series of 16 such cases, that there is no increased complication rate as a result of preoperative irradiation and that this should not be considered a contraindication to the Kock procedure.

Megestrol acetate plus minidose diethylstilbestrol in the treatment of carcinoma of the prostate.

A multicenter randomized trial comparing megestrol acetate 120 mg/d, plus diethylstilbestrol (DES) 0.1 to 3 mg/d in patients with stage D2 prostate cancer was undertaken to compare the efficacy and toxicity of these two regimens. Pretreatment characteristics, including pathologic grade, performance status, age, and disease-related symptoms were similar in the two groups. Of 81 patients who have been entered in the study, 77 are evaluable for response and toxicity at a mean follow-up of 13.3 months. Using National Prostate Cancer Project (NPCP) criteria, no difference in response rate is noted (73% v 76%) or in disease-free survival and overall survival. The ability to suppress serum testosterone to castration levels and to maintain this suppression is equivalent in both treatment groups. However, treatment-related toxicity, including edema, hypertension, and gynecomastia, occurred at a significantly greater frequency, severity, and after a shorter treatment period in the DES-treated group. No difference in major cardiovascular events was noted. Since megestrol acetate plus minidose DES is equivalent to DES in achieving treatment responses in patients with carcinoma of the prostate, it is a preferable treatment because of its improved side-effect profile.

Economic evaluation of extracorporeal shock wave lithotripsy, percutaneous ultrasonic lithotripsy, and standard surgical treatment of urolithiasis--a Canadian perspective.

In order to provide information for decision making regarding urolithiasis treatment programs for the population of the Central West Region (population 1.8 million) of Ontario, we conducted an incremental cost-effectiveness analysis of standard surgery, percutaneous ultrasonic lithotripsy, and extracorporeal shock wave lithotripsy for the removal of renal and ureteric stones. Estimates of costs and effects were calculated for a 5-year period, beginning in 1985. Direct medical costs estimated were fees, both professional and technical, operating costs, and hospitalization costs for standard surgery, percutaneous ultrasonic lithotripsy, and extracorporeal shock wave lithotripsy. Capital costs, opportunity costs, and depreciation were included for extracorporeal shock wave lithotripsy, but not for standard surgery or percutaneous ultrasonic lithotripsy, thus creating a bias against extracorporeal shock wave lithotripsy. All costs were expressed in 1985 Canadian dollars; both costs and effects from years 2-5 were discounted using a rate of 5%. The effects estimated were disability days. Failure rates, complication rates, length of hospital stay, and disability days were median values reported in the medical literature. Assuming 400 procedures per year (based on previous experience in the Central West Region), the total 5-year costs in millions of dollars, were 8.86 for standard surgery, 7.84 for extracorporeal shock wave lithotripsy, and 7.51 for percutaneous ultrasonic lithotripsy. Costs per procedure were 4,429 for standard surgery, 3,918 for extracorporeal shock wave lithotripsy, and 3,756 for percutaneous ultrasonic lithotripsy. The total disability days generated were 69,098 for standard surgery, 18,184 for percutaneous ultrasonic lithotripsy, and 9,092 for extracorporeal shock wave lithotripsy. Because standard surgery costs more and generates more disability days than either percutaneous ultrasonic lithotripsy or extracorporeal shock wave lithotripsy, it is clearly the least desirable alternative. At 400 procedures per year, the cost of each disability day averted by extracorporeal shock wave lithotripsy, compared to percutaneous ultrasonic lithotripsy, is $35.60. At 500 procedures per year, extracorporeal shock wave lithotripsy costs less and generates fewer disability days than percutaneous ultrasonic lithotripsy and is therefore the desired alternative. Sensitivity analyses demonstrate that cost effectiveness results are most affected by the number of procedures performed, the length of stay, and the number of disability days generated.

Carcinoma of the prostate.

Prostatic carcinoma is the third most common cause of death from cancer among males. Selection of appropriate therapy and evaluation of results is often difficult, since patients present at different stages of the disease. Methods of staging, diagnosis, treatment of localized tumor, radiation, surgery and treatment of metastases are described.

Osseous metastases secondary to renal cell carcinoma.

We present the distribution of metastases and clinical course of 252 patients with osseous metastases secondary to renal cell carcinoma. Symptoms of the metastases were the presenting complaint in 48 per cent of patients (including 37 with pathologic fractures); the axial skeleton was the most commonly involved site. Despite earlier reports that nephrectomy lengthened survival for patients with osseous metastases, our data showed this to be true only for patients with a solitary osseous metastasis. Patients with multiple osseous metastases had survival rates no better than patients with soft tissue or mixed lesions-whether or not nephrectomy was performed.

Liver scanning in malignant genitourinary tumours.

To assess the value of liver scanning as a routine pretreatment screening test for metastatic spread in patients with malignant genitourinary tumours, the authors reviewed the records of 68 such patients who underwent liver scanning. Of 74 scans obtained, 10 gave positive results. There was a 6% false-positive rate and in five of six true-positive scans other clinical and laboratory data indicated the presence of distant metastatic spread. The liver scan provided new information in only one case. The authors conclude that routine liver scanning before treatment is not warranted in patients with malignant genitourinary tumours.

Transurethral electroincision of bladder neck in female patients with neurogenic bladder.

Transurethral electroincision of the bladder neck in female patients with neurogenic bladders has not been widely reported. We have performed this operation on 21 patients who have failed to achieve balanced bladder function through other treatment modalities and who have presented with recurrent urinary tract infections, high postvoid residual urine, and evidence of upper urinary tract deterioration. Eighty-five per cent of female patients treated in this fashion have demonstrated significant improvement in bladder emptying. The rate of complication has been low, and no cases of persistent incontinence have occurred. We recommend this operation in difficult cases of neurogenic bladder in females.

Testicular scanning: its efficacy in diagnosing intrascrotal lesions.

Radionuclide scanning is a relatively new diagnostic aid for evaluating intrascrotal lesions. The authors present a retrospective analysis of 34 patients who underwent testicular scanning from 1973 to 1978. While the technique may be helpful, misleading results are not uncommon and caution should be exercised in interpreting the results. In this series 22% of scans obtained in cases of testicular torsion and acute epididymitis failed to provide the correct diagnosis. In view of the serious consequence of testicular loss when surgical exploration is delayed, testicular scanning should not be relied upon to the exclusion of other more traditional methods.