PURPOSE: We assessed the efficacy and most appropriate dosage of trospium chloride (TCl) for managing bladder instability in children as compared with a placebo. MATERIALS AND METHODS: A total of 58 patients with bladder instability were allocated at random to 1 of 5 groups-10, 15, 20 or 25 mg TCl, or placebo administered daily in a multicenter, randomized, single-blind clinical study. Patients were treated for 21 days, and current symptoms, voiding diary and urodynamic values were collected at the beginning and end of the treatment period. All adverse events were recorded at the last visit. RESULTS: Of 50 patients treated with TCl 41 (82%) had a positive therapeutic result (excellent, good or fair) versus only 3 of 8 patients with improvement in the placebo group (37.5%, p = 0.006). In all responding patients clinical symptoms either resolved or decreased markedly, and in 37 (74%) this improvement was accompanied by urodynamic improvement. In these 37 children the average number of uninhibited contractions decreased by 54.3% (p <0.0001) and the volume at first contraction increased by 71.4% (p = 0.001). There were no statistically significant differences with regard to therapeutic efficacy between TCl dosages. Fourteen patients (9 with TCl, 5 with placebo) showed no clinical improvement, although some had improved urodynamic parameters. Furthermore, TCl was well tolerated with few patients (10%) experiencing adverse effects. CONCLUSIONS:Trospium chloride (10 to 25 mg total daily dosage, split into 2 doses) is an effective option for the management of detrusor instability in children.
RCT Entities:
PURPOSE: We assessed the efficacy and most appropriate dosage of trospium chloride (TCl) for managing bladder instability in children as compared with a placebo. MATERIALS AND METHODS: A total of 58 patients with bladder instability were allocated at random to 1 of 5 groups-10, 15, 20 or 25 mg TCl, or placebo administered daily in a multicenter, randomized, single-blind clinical study. Patients were treated for 21 days, and current symptoms, voiding diary and urodynamic values were collected at the beginning and end of the treatment period. All adverse events were recorded at the last visit. RESULTS: Of 50 patients treated with TCl 41 (82%) had a positive therapeutic result (excellent, good or fair) versus only 3 of 8 patients with improvement in the placebo group (37.5%, p = 0.006). In all responding patients clinical symptoms either resolved or decreased markedly, and in 37 (74%) this improvement was accompanied by urodynamic improvement. In these 37 children the average number of uninhibited contractions decreased by 54.3% (p <0.0001) and the volume at first contraction increased by 71.4% (p = 0.001). There were no statistically significant differences with regard to therapeutic efficacy between TCl dosages. Fourteen patients (9 with TCl, 5 with placebo) showed no clinical improvement, although some had improved urodynamic parameters. Furthermore, TCl was well tolerated with few patients (10%) experiencing adverse effects. CONCLUSIONS:Trospium chloride (10 to 25 mg total daily dosage, split into 2 doses) is an effective option for the management of detrusor instability in children.