Abstract

For more than 20 years emepronium bromide has been used in the treatment of urgency and urge incontinence. Different dosages have been used and several studies made, but a real double-blind controlled study has never been performed in patients with the same urodynamic findings. Two studies have been carried out: (A) A double-blind controlled crossover clinical trial, estimating the effect of emepronium bromide 200 t.i.d. against 100 mg t.i.d. and one placebo. (B) An open clinical trial where urodynamic parameters were combined under treatment with emepronium bromide in the two doses mentioned. Renal and liver function was also tested and finally the level of the drug in serum was determined. The results of investigation A showed: (1) the patients (statistically significant) preferred the effect of the emepronium medication, 200 mg t.i.d., whereas it was impossible to separate the effect of 100 mg t.i.d. from the placebo effect, and (2) the result was in accordance with the reduction of frequency of micturition, which dereased significantly with 10–20%. The results of investigation B showed: (1) no increase of residual urine; (2) the total volume at first bladder contraction has statistically increased in patients with detrusor hyperreflexia; (3) bladder capacity was increased in patients with left-shift cystometrograms; (4) the urethral closure pressure profile showed no changes under medication; (5) renal and liver function was not influenced by emepronium, and (6) a minimum concentration of emepronium in serum – about 20–30 µg/l – is necessary to give a satisfactory effect on the bladder. This level is only reached under treatment with emepronium bromide 200 mg t.i.d.

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