الفهرس | Only 14 pages are availabe for public view |
Abstract Background: Non-neurogenic voiding dysfunction is a common problem in pediatric population. It affects 17-22% of children above the age of 5 years. Diagnosis of voiding dysfunction depends mainly on symptoms, voiding diary and specific questionnaires. Antimuscarinic drugs have been widely used as first line medical treatment for these children. The limited efficacy and serious side effects of antimuscarinic drugs in some children necessitated the recent use of beta 3 agonists. Aim of the work: The purpose of this study is to evaluate the efficacy and safety of the Beta 3 agonist drug (Mirabegron) in comparison to the anticholinergic drug (Solifenacin) for children with non-neurogenic voiding dysfunction refractory to behavioral therapy. Patients and Methods: A Prospective randomized controlled trial was conducted between February 2022 and January 2023 on children with non-neurogenic voiding dysfunction not responding to behavioral therapy. Patients were randomized into 2 groups: group 1 (Mirabegron) and group 2 (Solifneacin). Patients were assessed using dysfunctional voiding scoring system (DVSS), flow curve and voiding diary at the beginning and end of the study. Adverse effects were specifically recorded. Results: A total of 72 patients completed the study with a mean age of (9.2 ± 2.3). At the end of treatment, both groups showed significant improvement in DVSS and voiding diary compared to baseline data (p <0.001). Mirabegron group showed significantly better efficacy than Solifenacin group based on DVSS score. Improvement ≥ 50% of the score of the DVSS questionnaire was achieved in 34 of 36 (94%) patients on Mirabegron versus 27 of 36 (75%) patients on Solifenacin (P=0.02). Complete improvement of symptoms down to a score of 0 in DVSS was observed in 8 of 36 patients in Mirabegron group (22%) compared to 3 of 36 patients in Solifenacin group (8%). Moreover, Mirabegron group had significantly better safety profile. Side effects were reported in 7 of 36 (19.4%) of Mirabegron group compared to 17 of 36 (47.2%) of Solifenacin group (p=0.01). Conclusion: Mirabegron appears to be more effective than Solifenacin in treatment of children with voiding dysfunction especially when considering it as a complex problem comprising different aspects of urinary and bowel symptoms as based on validated questionnaires. It is also more safe and tolerable especially in children who are expected to be subjected to medical treatment for an extended period of time. Recommendations: Beta 3 agonists (Miabegron) should be recommended as a standard treatment for children with voiding dysfunction refractory to behavioral therapy. |