Fábio Quintiliano1, Maria Luiza Veiga1, Marília Moraes1, Carolina Cunha1, Liliana Fajardo de Oliveira1, Patrícia Lordelo1, José Murillo Bastos Netto1, Ubirajara Barroso Júnior2. 1. Division of Pediatric Urology, Department of Urology, Bahia School of Medicine, Salvador, Bahia, Brazil; Divisions of Urology, Departments of Surgery, Federal University of Juiz de Fora and School of Health and Medical Sciences of Juiz de Fora, Juiz de Fora (LFdO, JMBN), Minas Gerais, Brazil. 2. Division of Pediatric Urology, Department of Urology, Bahia School of Medicine, Salvador, Bahia, Brazil; Divisions of Urology, Departments of Surgery, Federal University of Juiz de Fora and School of Health and Medical Sciences of Juiz de Fora, Juiz de Fora (LFdO, JMBN), Minas Gerais, Brazil. Electronic address: ubarroso@uol.com.br.
Abstract
PURPOSE: We determined the effectiveness of 2 methods to treat overactive bladder in children using intragroup and intergroup comparisons in a randomized clinical trial. MATERIALS AND METHODS:Nine boys and 19 girls with a mean ±SD age of 6.4 ± 2.18 years were randomly divided into group 1-parasacral transcutaneous electrical stimulation with placebo drug and group 2-oxybutynin with sham scapular electrical therapy. Success was assessed by 1) the rate of complete symptom resolution, 2) a visual analog scale of 0 to 10, 3) the dysfunctional voiding score system, 4) voiding diary records, 5) Rome III criteria and 6) side effect frequency in each group. RESULTS:A total of 13 and 15 patients were randomized to groups 1 and 2, respectively. Symptoms completely resolved in 6 patients in group 1 (46%) and 3 in group 2 (20%) (p = 0.204). A statistically significant improvement was found in the 2 groups in the dysfunctional voiding score system and voiding diary records. However, no statistically significant difference was found between the groups in the visual analog scale score, voiding frequency, and maximum and meanvoided volume (p = 0.295, 0.098, 0.538 and 0.650, respectively). Constipation improved in 100% of group 1 patients but in only 55% in group 2 (p = 0.031 vs 0.073). Group 1 showed no side effects while dry mouth, hyperthermia and hyperemia developed in 58%, 25% and 50% of group 2 patients (p = 0.002, 0.096 and 0.005, respectively). Treatment was discontinued by 13.3% of patients in group 2. CONCLUSIONS:Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children. However, transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects. Oxybutynin was more effective for decreasing voiding frequency.
RCT Entities:
PURPOSE: We determined the effectiveness of 2 methods to treat overactive bladder in children using intragroup and intergroup comparisons in a randomized clinical trial. MATERIALS AND METHODS: Nine boys and 19 girls with a mean ± SD age of 6.4 ± 2.18 years were randomly divided into group 1-parasacral transcutaneous electrical stimulation with placebo drug and group 2-oxybutynin with sham scapular electrical therapy. Success was assessed by 1) the rate of complete symptom resolution, 2) a visual analog scale of 0 to 10, 3) the dysfunctional voiding score system, 4) voiding diary records, 5) Rome III criteria and 6) side effect frequency in each group. RESULTS: A total of 13 and 15 patients were randomized to groups 1 and 2, respectively. Symptoms completely resolved in 6 patients in group 1 (46%) and 3 in group 2 (20%) (p = 0.204). A statistically significant improvement was found in the 2 groups in the dysfunctional voiding score system and voiding diary records. However, no statistically significant difference was found between the groups in the visual analog scale score, voiding frequency, and maximum and mean voided volume (p = 0.295, 0.098, 0.538 and 0.650, respectively). Constipation improved in 100% of group 1 patients but in only 55% in group 2 (p = 0.031 vs 0.073). Group 1 showed no side effects while dry mouth, hyperthermia and hyperemia developed in 58%, 25% and 50% of group 2 patients (p = 0.002, 0.096 and 0.005, respectively). Treatment was discontinued by 13.3% of patients in group 2. CONCLUSIONS: Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children. However, transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects. Oxybutynin was more effective for decreasing voiding frequency.