Luis H Braga1, Mandy Rickard2, Forough Farrokhyar2, Kizanee Jegatheeswaran2, Natasha Brownrigg2, Christine Li2, Rahul Bansal2, Jorge DeMaria2, Armando J Lorenzo2. 1. McMaster Pediatric Surgery Research Collaborative (KJ, CL, JD), Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University (LHB, FF), Hamilton, Ontario, Canada; Clinical Urology Research Enterprise Program, McMaster Children's Hospital (LHB, MR, FF, KJ, NB, JD, AJL), Hamilton, Ontario, Canada; Division of Urology, Hospital for Sick Children (AJL), Toronto, Ontario, Canada. Electronic address: braga@mcmaster.ca. 2. McMaster Pediatric Surgery Research Collaborative (KJ, CL, JD), Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University (LHB, FF), Hamilton, Ontario, Canada; Clinical Urology Research Enterprise Program, McMaster Children's Hospital (LHB, MR, FF, KJ, NB, JD, AJL), Hamilton, Ontario, Canada; Division of Urology, Hospital for Sick Children (AJL), Toronto, Ontario, Canada.
Abstract
PURPOSE: We evaluated whether an animated bladder training video was as effective as standard individual urotherapy in improving bladder/bowel symptoms. MATERIALS AND METHODS: Patients 5 to 10 years old who scored greater than 11 on the bladder/bowel Vancouver questionnaire were included in a noninferiority randomized, controlled trial. Children with vesicoureteral reflux, neuropathic bladder, learning disabilities, recent urotherapy or primary nocturnal enuresis were excluded from analysis. Patients were randomly assigned to receive standard urotherapy or watch a bladder training video in clinic using centralized blocked randomization schemes. Bladder/bowel symptoms were evaluated at baseline and 3-month followup by intent to treat analysis. A sample size of 150 patients ensured a 3.5 difference in mean symptomology scores between the groups, which was accepted as the noninferiority margin. RESULTS: Of 539 screened patients 173 (37%) were eligible for study and 150 enrolled. A total of 143 patients (95%) completed the trial, 5 (4%) were lost to followup and 2 (1%) withdrew. Baseline characteristics were similar between the groups. Baseline mean ± SD symptomology scores were 19.9 ± 5.5 for the bladder training video and 19.7 ± 6.0 for standard urotherapy. At 3 months the mean symptomology scores for the bladder training video and standard urotherapy were reduced to 14.4 ± 6.5 and 13.8 ± 6.0, respectively (p = 0.54). The mean difference was 0.6 (95% CI -1.4-2.6). The upper 95% CI limit of 2.6 did not exceed the preset 3.5 noninferiority margin. CONCLUSIONS: The bladder training video was not inferior to standard urotherapy in reducing bladder/bowel symptoms in children 5 to 10 years old. The video allows families to have free access to independently review bladder training concepts as often as necessary.
RCT Entities:
PURPOSE: We evaluated whether an animated bladder training video was as effective as standard individual urotherapy in improving bladder/bowel symptoms. MATERIALS AND METHODS:Patients 5 to 10 years old who scored greater than 11 on the bladder/bowel Vancouver questionnaire were included in a noninferiority randomized, controlled trial. Children with vesicoureteral reflux, neuropathic bladder, learning disabilities, recent urotherapy or primary nocturnal enuresis were excluded from analysis. Patients were randomly assigned to receive standard urotherapy or watch a bladder training video in clinic using centralized blocked randomization schemes. Bladder/bowel symptoms were evaluated at baseline and 3-month followup by intent to treat analysis. A sample size of 150 patients ensured a 3.5 difference in mean symptomology scores between the groups, which was accepted as the noninferiority margin. RESULTS: Of 539 screened patients 173 (37%) were eligible for study and 150 enrolled. A total of 143 patients (95%) completed the trial, 5 (4%) were lost to followup and 2 (1%) withdrew. Baseline characteristics were similar between the groups. Baseline mean ± SD symptomology scores were 19.9 ± 5.5 for the bladder training video and 19.7 ± 6.0 for standard urotherapy. At 3 months the mean symptomology scores for the bladder training video and standard urotherapy were reduced to 14.4 ± 6.5 and 13.8 ± 6.0, respectively (p = 0.54). The mean difference was 0.6 (95% CI -1.4-2.6). The upper 95% CI limit of 2.6 did not exceed the preset 3.5 noninferiority margin. CONCLUSIONS: The bladder training video was not inferior to standard urotherapy in reducing bladder/bowel symptoms in children 5 to 10 years old. The video allows families to have free access to independently review bladder training concepts as often as necessary.