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Purpose: We study toxicity and efficacy of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin (BCG) in patients with intermediate or high risk superficial bladder cancer compared to the use of intravesical mitomycin C alone., Materials and Methods: Patients with intermediate and high risk papillary superficial bladder cancer and carcinoma in situ were randomized after transurethral resection between 4 weekly instillations with 40 mg. mitomycin C followed by 6 weekly instillations with BCG (group 1, 90 patients) or 10 weekly instillations with mitomycin C (group 2, 92 patients)., Results: The frequency of bacterial and chemical cystitis, and other local side effects was similar in both groups. Allergic reactions, including skin rash, were more frequent in the mitomycin C only group (12 of 92 patients versus 5 of 90, p = 0.08), and other systemic side effects were more frequent in the sequential group (16 of 90 versus 8 of 92, p = 0.07). After a median followup of 32 months the number of recurrences (sequential 35 of 90 patients versus mitomycin C only 42 of 92, p = 0.36) and progression (5 of 90 versus 4 of 92 respectively, p = 0.70) were similar in both groups., Conclusions: We did not find any major differences in toxicity or treatment efficacy with intravesical mitomycin C and the sequential use of BCG or mitomycin C for intermediate and high risk superficial papillary bladder cancer.

Purpose: We compared the outcome of transurethral resection of the prostate and high energy microwave thermotherapy in patients with benign prostatic hyperplasia., Materials and Methods: Of 52 patients with symptomatic benign prostatic hyperplasia 21 (mean age plus or minus standard deviation 69.6 +/- 8.5 years) were treated with transurethral resection of the prostate and 31 (mean age 69.3 +/- 5.9 years) were treated with high energy microwave thermotherapy. Patients were assessed using the Madsen symptom score, measurements of voiding parameters, transrectal ultrasound and cystometry, including pressure-flow analyses. Examinations were repeated at fixed intervals for up to 12 months after treatment., Results: After transurethral resection and thermotherapy there was significant improvement in all clinical parameters. At 1 year of followup symptomatic improvement was 78% in the transurethral resection group versus 68% in the thermotherapy group, with improvements in free flow rate of 100 and 69%, respectively. Both groups had significant relief of bladder outlet symptoms. No serious complications occurred in either group, while 1 patient in each group required repeat treatment., Conclusions: Satisfactory results were obtained after both treatments, with improvements following high energy microwave thermotherapy being in the same range as those after transurethral resection of the prostate.

Purpose: We investigated the international differences in the reporting of lower urinary tract symptoms and related bother in patients with symptoms suggestive of bladder outlet obstruction., Materials and Methods: Multiple logistic regression analysis was used to evaluate international differences in the reporting of lower urinary tract symptoms and related bother in 1,271 patients from 12 countries who participated in the International Continence Society "benign prostatic hyperplasia" study., Results: Country of origin was significantly associated with the prevalence of a large number of lower urinary tract symptoms (10 of 20), even after adjusting for potentially confounding variables, including physical and socio-demographic factors. Country of origin was also significantly associated with the reporting of bother but for a much smaller number of symptoms (2)., Conclusions: In different countries lower urinary tract symptoms may be reported to different extents. Therefore, the results of studies in particular countries may not be generally applicable to other countries. It is likely that symptom scores will conceal this variation, necessitating consideration of individual symptoms (as in the International Continence Society "benign prostatic hyperplasia" study) or the development of country specific scoring systems. An alternative would be to focus on bother, which appeared to be much less sensitive to international differences.

Purpose: We quantified the physiological variability of clinical and pressure-flow study variables in patients with symptomatic benign prostatic enlargement., Materials and Methods: Symptom scores were measured, and advanced urodynamic studies with pressure-flow analysis were performed in 178 patients before and 6 months after a period a watchful waiting., Results: Patients without bladder outlet obstruction experienced significant symptomatic improvement. Symptoms in patients with obvious bladder outlet obstruction did not improve significantly. The reproducibility of mean pressure-flow variables was evident. However, there was an important intra-individual variability. Patients with obvious bladder outlet obstruction showed a significant decreases in detrusor pressure at maximal flow of 14cm. water, a significant decrease in the urethral resistance factor of 7 cm. water and a significant decrease of 1 obstruction class on the linear passive urethral resistance relation nomogram, indicating less severe bladder outlet obstruction., Conclusions: Mean differences among therapy groups must be regarded critically, especially when the difference are slight and possibly within physiological variability.

Purpose: We evaluated the urodynamic and clinical effects of terazosin in patients with symptomatic benign prostatic hyperplasia (BPH)., Materials and Methods: A total of 45 patients who participated in a multicenter trial was evaluated with urodynamic pressure-flow studies before and after 26 weeks of treatment., Results: Maximum flow rate and symptom score improved significantly in 22 patients with and 11 without bladder outlet obstruction who completed 26 weeks of treatment. In patients with bladder outlet obstruction the condition was significantly reduced and in patients without obstruction, significant urodynamic changes could not be detected., Conclusions: Terazosin treatment results in symptomatic relief and improved urinary flow in patients with and without bladder outlet obstruction, and in significant improvement in patients with urodynamically proved obstruction.

Purpose: To assess the pharmacodynamic equivalence of the new 10.8 mg. goserelin depot with the current 3.6 mg. depot 3 studies were performed in patients with advanced prostate cancer., Materials and Methods: In 2 comparative studies 160 patients were randomized for dosing every 12 weeks using the 10.8 mg. depot or every 4 weeks using the 3.6 mg. depot. In the noncomparative study 35 patients received the 10.8 mg. depot. Blood sampling for serum testosterone and evaluation of toxicity was done during the 48-week study period., Results: Serum testosterone profiles of the 10.8 and 3.6 mg. goserlin depots were similar with testosterone levels decreasing into the castrate range by day 21 after depot administration. The safety profile of 10.8 mg. goserelin is comparable to that of the current monthly depot with the main side effects related to androgen deprivation., Conclusions: The new long acting depot was pharmacologically equivalent, and well tolerated locally and systemically, and will offer added convenience to patients and health care personnel.

Results of a randomized prospective study are reported in which mitomycin C, Tice bacillus Calmette-Guerin (BCG) and RIVM-BCG were compared in 437 patients with primary or recurrent pTa and pT1 bladder tumors, including carcinoma in situ. The followup (or time in study) varied from 2 to 81 months (mean 36 months). After complete transurethral resection of all visible tumors the patients were treated with 30 mg. mitomycin C once a week for 4 consecutive weeks and thereafter every month for a total of 6 months, and 5 x 10(8) colony-forming units Tice BCG or RIVM-BCG once a week for 6 consecutive weeks. For papillary tumors mitomycin C and RIVM-BCG treatments were equally effective (p = 0.53), and mitomycin C was more effective than Tice BCG therapy (p = 0.01).