G. Frohlich et al., INTRAVESICAL TROSPIUM CHLORIDE, OXYBUTYNI N AND VERAPAMIL FOR RELAXATION OF DETRUSOR MUSCLE - A PLACEBO-CONTROLLED, RANDOMIZED CLINICAL-TRIAL, Arzneimittel-Forschung, 48(5), 1998, pp. 486-491
Therapy of detrusor hyperactivity with anticholinergic agents often is
followed by adverse drug reactions. Intravesical application may be a
n interesting alternative. A randomised, single-blind, placebo-control
led, mono-centre clinical trial was carried out in 84 patients with ur
gency or urge incontinence. Due to intravesical administration of oxyb
utynin (CAS 5633-20-5) (n = 21) and trospium chloride (CAS 10405-02-4)
(n = 21), respectively, a significant increase in maximum bladder cap
acity and decrease of detrusor pressure accompanied by an increase of
residual urine were found in comparison to placebo in urodynamical inv
estigations. Improvement of uninhibited bladder contractions occured l
eading to higher filling volume. Under verapamil (CAS 152-11-4) (n = 2
1) no marked changes in the efficacy variables were found compared wit
h placebo. All patients completed the study and were assessed with reg
ard to efficacy and safety. No adverse events or marked changes in the
vital signs were reported. The immediate onset of effect and the lack
of adverse drug reactions suggest that treatment with topical oxybuty
nin or trospium chloride is an effective alternative in patients with
intolerable side effects when orally treated. In addition, intravesica
l administration may be indicated in patients with bladder spasms due
to indwelling catheter or in order to increase bladder capacity before
percutaneous cystostomy.