Aims of the study: The aim of this double-blind, randomised, prospective, multicentre trial was to evaluate the ecacy of propiverine in patients suering from detrusor hyperre¯exia caused by spinal cord injury in comparison to placebo. Study design: The treatment period of 14 days comprised visits at baseline (V1) and after 14 days treatment (V2). Fifteen mg propiverine t.i.d. or placebo t.i.d. were administered as medication. The following ecacy parameters were adopted: the urodynamic parameters maximal cystometric bladder capacity, bladder volume on onset of the ®rst as well as duration and amplitude of the maximum detrusor contraction, bladder compliance and residual urine, and subjective assessment of ecacy by physicians. For the evaluation of the safety of propiverine the incidence rate of adverse events by directly questioning as well as laboratory parameters were investigated. For biometrical evaluation t-test for independent groups was applied. Results: One hundred and thirteen patients were investigated. The maximal cystometric bladder capacity increased signi®cantly in the propiverine group, on average by 104 ml (V1: 262+132 ml. V2: 366+143 ml, P50.001). The changes in bladder capacity during the ®rst contraction and the maximum detrusor contraction in the verum group were both statistically signi®cant. The bladder compliance documented a more pronounced increase under propiverine in comparison to placebo. Residual urine increased by 37+71 ml in the propiverine group, signi®cantly more than in the placebo group (P=0.01). Sixty-three per cent of the patients expressed subjectively an improvement under propiverine in comparison with 23% of the placebo group. Expected anticholinergic adverse events occurred: dryness of the mouth (37% in the verum and 8% in the placebo group), accommodation disorders (28% and 2% respectively). Nausea, constipation, headache, dizziness, tiredness and palpitations were reported in almost comparable incidence rates between 3 and 13% in both treatment groups.Eight drop-outs were registered in the propiverine group (®ve due to adverse events) and three in the placebo group (one due to adverse events). The laboratory parameters revealed no changes. Conclusion: Propiverine proved its ecacy in detrusor hyperre¯exia with regard to the urodynamic parameters of the maximal cystometric bladder capacity and detrusor contractility. Anticholinergic adverse events such as dryness of the mouth and accommodation disorders were considered being tolerable. The increase in residual urine re¯ects the therapeutically desired eect of detrusor relaxation because the majority of patients normally practise intermittent catheterisation for bladder emptying.

The efficacy and tolerability of propiverine hydrochloride (15, off 45, 60 mg/d) were evaluated in the treatment of 185 patients suffering from urgency/urge incontinence in an open, randomized, multicentre parallel-group trial lasting 21 days. The effects on bladder volume and pressure were assessed on the basis of urodynamics and micturition frequency. Subjective adverse reactions were recorded. The bladder capacity and compliance increased and bladder pressure decreased in a dose dependent manner following therapy with 15, 30, 45 and 60 mg/d. In 70% of the patients a decrease in micturition frequency was observed after 15 mg/d, and in 80% after 30 to 60 mg/d. Subjective anticholinergic symptoms were reported by 21, 40 and 28% of the patients following therapy with 30, 45 and 60 mg/d. 15 and 30 mg were the daily doses with the most favourable ratio of efficacy in micturition frequency to tolerability. The results suggest that propiverine is a safe and effective drug for the treatment of urgency and urge incontinence. Individual treatment with an initial dosage of 30 mg/d should be recommended.

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With the introduction of integrated semiconductor pressure pick-ups into the urodynamic methodology of analysis, the bladder and urethral manometry has been optimized, since the measuring transducer is positioned directly inside the lumen of the bladder. In this way, it is possible to eliminate the errors of conventional measuring methods with the liquid-filled or gas-filled catheter system, for example movements, vibrations, hydrostatic influences on the coupling medium by different vertical positions of the catheter or connecting tube, as well as cloggings due to haematuria or secretion of mucus. Owing to its dimensions and radiopaque properties, the IBW 78 tip manometer is suitable also for the pressure measurement in the upper urinary passages including the pyelon. The pressure signals obtained are further processed in a special plug-in unit for the biomonitor system, and thus they can be recorded on any multiple recorder.