Efficacy and safety of propiverine in SCI-patients suffering from detrusor hyperreflexia--a double-blind, placebo-controlled clinical trial.
AIMS OF THE STUDY: The aim of this double-blind, randomised, prospective, multicentre trial was to evaluate the efficacy of propiverine in patients suffering from detrusor hyperreflexia 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 efficacy parameters were adopted: the urodynamic parameters maximal cystometric bladder capacity, bladder volume on onset of the first as well as duration and amplitude of the maximum detrusor contraction, bladder compliance and residual urine, and subjective assessment of efficacy 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 significantly in the propiverine group, on average by 104 ml (V1: 262+/-132 ml. V2: 366+/-143 ml, P<0.001). The changes in bladder capacity during the first contraction and the maximum detrusor contraction in the verum group were both statistically significant. 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, significantly 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 (five 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 efficacy in detrusor hyperreflexia 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 reflects the therapeutically desired effect of detrusor relaxation because the majority of patients normally practise intermittent catheterisation for bladder emptying.