[Clinical trial to evaluate trospium chloride (Uraplex) effectiveness and tolerance in patients with detrusor instability incontinence and its impact on quality of life].

OBJECTIVE

To determine the efficacy, tolerance and quality-of-life effects of trospium chloride in women with overactive bladder.

METHODS

An open, prospective multicenter trial was conducted on 75 women with urinary incontinence from overactive bladder (ICS criteria, urodynamic evaluation). Trospium chloride was administered at a dose of 20 mg twice daily for 8 weeks. Neurological examination and cystometry were performed at the start of the trial. Quality of life was evaluated by analogue visual scales (faces scale) and EUROQOL (health status scale). At the 4th week, urodynamic, clinical, quality-of-life and tolerance evaluations were performed. Clinical and tolerance data and quality of life index were assessed at the 8th week.

RESULTS

8 of the 75 patients did not complete the study. Thus, analysis of the therapeutic efficacy was performed in 67 patients, while description and tolerance analyses were performed for the overall group of patients. Urodynamic parameters significantly improved at 4 weeks: maximum bladder capacity (232.09 ml pre-treatment vs 315.83 ml post-treatment) and first desire to void (100.9 ml pre-treatment vs 156.7 ml post-treatment). Incontinence clinical items also improved. All quality-of-life indixes significantly increased at the 4 and 8 weeks control evaluation. Excellent or very good tolerance was observed in 89.5% of the patients.

CONCLUSIONS

The results of the study corroborate the efficacy and tolerance of trospium chloride in the management of overactive bladder in women. Improvement in patient quality of life was also observed.