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Bladder Training Video Versus Standard Urotherapy for Bladder and Bowel Dysfunction: A Non-Inferiority Randomized Controlled Trial
Braga L.H., Rickard M., Farrokhyar F., Jegatheeswaran K., Brownrigg N., Li C., Bansal R., DeMaria J., Lorenzo A.J.
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Commented by Konstantinos Kamperis
This paper compares standard individualized urotherapy to a 7 minute animated video made for the same purpose in children with bladder and bowel dysfunction. Participants were 150 children between the ages of 5 and 10 years. The authors demonstrate that urotherapy using an animated video is equally effective as standard urotherapy in terms of symptom-scores 3 months after initial assessment.
Bladder and bowel dysfunction is a common condition in children with a significant socioeconomic burden. Although these children can be successfully treated, the treatment is often demanding in terms of resources needed and very often these children are referred to specialized centers. To a large extent children with bladder and bowel dysfunction can be successfully treated with standard urotherapy alone. This study provides evidence that animated videos can successfully replace the initial urotherapeutic approach. This opens new possibilities for streamlined treatment of these children and at the same time reduce the burden of this condition for the medical practitioners caring for these children. The approach could be readily implemented in primary case reducing the number of children that need referral.
We evaluated if an animated bladder training video (BTV) was as effective as standard individual urotherapy (SU) in improving BBD symptoms.
Patients aged 5-10 years who scored >11 on the BBD Vancouver questionnaire were included in a non-inferiority randomized controlled trial. Children with vesicoureteral reflux, neuropathic bladder, learning disabilities, recent urotherapy and primary nocturnal enuresis were excluded. Patients were randomly assigned to receive either SU or BTV in clinic using centralized blocked randomization schemes. BBD symptoms were evaluated at baseline and at 3-month follow-up using an intention to treat analysis. A sample size of 150 patients ensured a 3.5 difference in mean symptomology scores between groups, accepted as the non-inferiority margin.
Of 539 screened patients, 173 (37%) were eligible and 150 enrolled. Of these, 143 (95%) completed the trial, 5 (4%) were lost to follow-up, and 2 (1%) withdrew. Baseline characteristics were similar between groups. Baseline mean symptomology scores were 19.9±5.5 for BTV and 19.7±6.0 for SU. At 3 months, the mean symptomology scores for both BTV and SU were reduced to 14.4±6.5 and 13.8±6.0 (p=0.54), respectively. The mean difference was 0.6 (95% CI; -1.4 to 2.6). The upper 95% CI limit of 2.6 did not exceed the pre-set 3.5 non-inferiority margin.
BTV is not inferior to SU in reducing BBD symptoms in children aged 5-10 years. BTV allows families free access to independently review bladder training concepts as often as necessary.