PURPOSE: This randomized blinded clinical study was designed to compare the efficacy of tolterodine treatment combined with behavioral modification, behavioral modification alone and behavioral modification plus placebo in children with nonneurogenic, nonanatomical voiding dysfunction. MATERIALS AND METHODS: A total of 72 children meeting inclusion criteria were randomly allocated to 1 of 3 groups. One group received tolterodine (1 mg twice daily) along with behavioral modification, 1 received behavioral modification only and 1 received placebo with behavioral modification. A dysfunctional voiding scoring system questionnaire was completed for all patients at the beginning of the study, and at 1 and 3 months of treatment. RESULTS:A total of 71 patients were evaluated. The groups did not differ with respect to age, gender and symptom score before study enrollment (p >0.05). Repeated calculations of symptom scores at 1 month of the treatment revealed a significant decrease in symptoms in all 3 groups, with a significant decrease in patients receiving tolterodine. In addition, at month 3 the symptom score of the tolterodine group was significantly lower compared to month 1, while scores remained steady in the behavioral modification and behavioral modification plus placebo groups. CONCLUSIONS:Tolterodine combined with behavioral modification for voiding dysfunction in children without neurological or anatomical abnormality can be recommended as a first line treatment before invasive evaluation.
RCT Entities:
PURPOSE: This randomized blinded clinical study was designed to compare the efficacy of tolterodine treatment combined with behavioral modification, behavioral modification alone and behavioral modification plus placebo in children with nonneurogenic, nonanatomical voiding dysfunction. MATERIALS AND METHODS: A total of 72 children meeting inclusion criteria were randomly allocated to 1 of 3 groups. One group received tolterodine (1 mg twice daily) along with behavioral modification, 1 received behavioral modification only and 1 received placebo with behavioral modification. A dysfunctional voiding scoring system questionnaire was completed for all patients at the beginning of the study, and at 1 and 3 months of treatment. RESULTS: A total of 71 patients were evaluated. The groups did not differ with respect to age, gender and symptom score before study enrollment (p >0.05). Repeated calculations of symptom scores at 1 month of the treatment revealed a significant decrease in symptoms in all 3 groups, with a significant decrease in patients receiving tolterodine. In addition, at month 3 the symptom score of the tolterodine group was significantly lower compared to month 1, while scores remained steady in the behavioral modification and behavioral modification plus placebo groups. CONCLUSIONS:Tolterodine combined with behavioral modification for voiding dysfunction in children without neurological or anatomical abnormality can be recommended as a first line treatment before invasive evaluation.