Propiverine hydrochloride immediate and extended release: comparison of efficacy and tolerability in patients with overactive bladder.

INTRODUCTION: This study aims to compare the efficacy of propiverine hydrochloride immediate release (IR), propiverine hydrochloride extended release (ER) and placebo for the treatment of overactive bladder syndrome. The primary outcome measure is incontinence episode frequency, with secondary outcome measures including mean volume per void and quality of life as assessed on King's Health Questionnaire. MATERIAL AND METHODS: The double-blind, double-dummy, randomized study compared IR 15 mg twice daily, ER 30 mg once daily and placebo in 3 parallel groups. After a run-in period of 7 days, the patients were treated for 32 days. Nine hundred and eighty-eight patients were randomized, and 910 patients completed the protocol without major violations. RESULTS: The number of incontinence episodes/24 h decreased by 2.26 in the IR group (p < 0.001 vs. placebo), by 2.46 in the ER group (p < 0.0001 vs. placebo) and by 1.75 in the placebo group. The most frequent adverse event was dry mouth with 22.8% of the patients in the IR group, 21.7% in the ER group and 6.4% in the placebo group. The overall tolerability was rated 'very good' or 'good' by more than 80% of the investigators and patients in all 3 groups. CONCLUSIONS: Propiverine ER 30 mg once daily and propiverine IR 15 mg twice daily significantly reduce the number of incontinence episodes/24 h within a treatment period of 32 days. Both formulations are safe and well tolerated. The extended release formulation of propiverine is a suitable new option for the treatment of the overactive bladder.

Ciprofloxacin 250 mg twice daily versus ofloxacin 200 mg twice daily in the treatment of complicated urinary tract infections in women.

In a multicenter, prospective, double-blind, double-dummy randomized study conducted in Israel and Germany, the efficacy and safety of ciprofloxacin 250 mg b.i.d. versus ofloxacin 200 mg b.i.d. was compared in the treatment of women with complicated lower urinary tract infection. A total of 465 women were enrolled in the study, 427 of whom were included in the intent-to-treat analysis. Two hundred fourteen received ciprofloxacin 250 mg b.i.d. and 213 received ofloxacin 200 mg b.i.d. Both regimens were administered for 7 days. The primary efficacy parameter was the microbiologic result obtained 5-9 days after cessation of therapy; secondary efficacy parameters were urine cultures obtained 28-42 days after the end of therapy and clinical outcome 5-9 days and 28-42 days post-therapy. There were no relevant differences in the primary efficacy parameter or in any secondary efficacy parameter between the average response rate of patients who received ciprofloxacin and that of patients who received ofloxacin: 90.1% of the ciprofloxacin group and 87.2% of the ofloxacin group had sterile urine 5-9 days after the end of therapy; 77.1% and 76.1% had sterile cultures, respectively. Clinical cure was achieved in 97.2% of both groups 5-9 days after cessation of therapy and a month later in 87.7% and 87.3%, respectively. Adverse events were mild and similar in both groups. In conclusion, for the primary efficacy parameter as well as for all secondary efficacy parameters, ciprofloxacin 250 mg b.i.d. is at least as effective as ofloxacin 200 mg b.i.d. in women with complicated lower urinary tract infection.