N Brownrigg1, L H Braga2, M Rickard1, F Farrokhyar3, B Easterbrook4, A Dekirmendjian4, K Jegatheeswaran4, J DeMaria5, A J Lorenzo6. 1. McMaster Children's Hospital, Hamilton, Ontario, Canada; Clinical Urology Research Enterprise (CURE) Program, Hamilton, Ontario, Canada. 2. McMaster Children's Hospital, Hamilton, Ontario, Canada; McMaster Pediatric Surgery Research Collaborative, Hamilton, Ontario, Canada; Clinical Urology Research Enterprise (CURE) Program, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. Electronic address: braga@mcmaster.ca. 3. McMaster Pediatric Surgery Research Collaborative, Hamilton, Ontario, Canada; Clinical Urology Research Enterprise (CURE) Program, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. 4. McMaster Pediatric Surgery Research Collaborative, Hamilton, Ontario, Canada. 5. McMaster Children's Hospital, Hamilton, Ontario, Canada; McMaster Pediatric Surgery Research Collaborative, Hamilton, Ontario, Canada; Clinical Urology Research Enterprise (CURE) Program, Hamilton, Ontario, Canada. 6. Clinical Urology Research Enterprise (CURE) Program, Hamilton, Ontario, Canada; The Hospital for Sick Children, Division of Urology, Toronto, Ontario, Canada.
Abstract
INTRODUCTION:Bladder and bowel dysfunction (BBD) can negatively impact the quality of life (QoL) of children. Urotherapy is an accepted treatment option for BBD; however, literature that examines the impact of management options on QoL in this population is scarce. OBJECTIVE: To determine whether a bladder training video (BTV) is non-inferior to standard urotherapy (SU) in improving QoL in children with BBD. METHODS:Children aged 5-10 years and who scored ≥11 on the Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire (NLUTD/DES) were recruited from a pediatric tertiary care center. Children were excluded with known vesicoureteral reflux; spinal dysraphism; learning disabilities; recent urotherapy; and primary nocturnal enuresis. Quality of life was evaluated using the Pediatric Incontinence Quality-of-Life questionnaire (PinQ). Questionnaires were administered at the baseline and 3-month follow-up clinic visits. Following centralized electronic blocked randomization schemes to guarantee allocation concealment, patients were assigned to receive SU or BTV during their regular clinic visits. An intention-to-treat protocol was followed. Between-group baseline and follow-up QoL scores were compared using paired and unpaired t-tests, and linear regression analysis. RESULTS: Of the 539 BBD patients who were screened, 173 (32%) were eligible, and 150 (87%) were randomized. Of these, 143 (96%) completed the study, five (3%) were lost to follow-up, and two (1%) withdrew. In total, 140/143 (97%) completed the QoL questionnaire at baseline and follow-up. Mean follow-up time was 3.5 ± 1.1 months for BTV patients and 3.7 ± 1.6 months for SU. At baseline, BTV and SU patients had a mean QoL score of 26.6 ± 13 and 23.8 ± 12, respectively (P = 0.17). Between-group mean change in PinQ scores from baseline was not statistically significant (BTV: 6.25 ± 12.5 vs SU: 3.75 ± 12.2; P = 0.23; Summary Fig.). Significant predictors of positive change in QoL were: higher symptomatology score, with a correlation coefficient of 0.5 (95% CI: 0.2-0.9; P = 0.003), and worse baseline QoL score, with a correlation coefficient of 0.5 (95% CI: 0.4-0.7; P < 0.001). Overall, most patients had improved symptomatology and QoL scores. CONCLUSION: Significant and similar QoL changes from baseline to follow-up were observed in both the BTV and SU groups, suggesting that BTV was non-inferior to SU in improving QoL in children with BBD. Quality of life assessment should be considered when evaluating interventions for BBD, as it appears to be an important clinical outcome with which to determine urotherapy success.
RCT Entities:
INTRODUCTION:Bladder and bowel dysfunction (BBD) can negatively impact the quality of life (QoL) of children. Urotherapy is an accepted treatment option for BBD; however, literature that examines the impact of management options on QoL in this population is scarce. OBJECTIVE: To determine whether a bladder training video (BTV) is non-inferior to standard urotherapy (SU) in improving QoL in children with BBD. METHODS:Children aged 5-10 years and who scored ≥11 on the Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire (NLUTD/DES) were recruited from a pediatric tertiary care center. Children were excluded with known vesicoureteral reflux; spinal dysraphism; learning disabilities; recent urotherapy; and primary nocturnal enuresis. Quality of life was evaluated using the Pediatric Incontinence Quality-of-Life questionnaire (PinQ). Questionnaires were administered at the baseline and 3-month follow-up clinic visits. Following centralized electronic blocked randomization schemes to guarantee allocation concealment, patients were assigned to receive SU or BTV during their regular clinic visits. An intention-to-treat protocol was followed. Between-group baseline and follow-up QoL scores were compared using paired and unpaired t-tests, and linear regression analysis. RESULTS: Of the 539 BBDpatients who were screened, 173 (32%) were eligible, and 150 (87%) were randomized. Of these, 143 (96%) completed the study, five (3%) were lost to follow-up, and two (1%) withdrew. In total, 140/143 (97%) completed the QoL questionnaire at baseline and follow-up. Mean follow-up time was 3.5 ± 1.1 months for BTVpatients and 3.7 ± 1.6 months for SU. At baseline, BTV and SUpatients had a mean QoL score of 26.6 ± 13 and 23.8 ± 12, respectively (P = 0.17). Between-group mean change in PinQ scores from baseline was not statistically significant (BTV: 6.25 ± 12.5 vs SU: 3.75 ± 12.2; P = 0.23; Summary Fig.). Significant predictors of positive change in QoL were: higher symptomatology score, with a correlation coefficient of 0.5 (95% CI: 0.2-0.9; P = 0.003), and worse baseline QoL score, with a correlation coefficient of 0.5 (95% CI: 0.4-0.7; P < 0.001). Overall, most patients had improved symptomatology and QoL scores. CONCLUSION: Significant and similar QoL changes from baseline to follow-up were observed in both the BTV and SU groups, suggesting that BTV was non-inferior to SU in improving QoL in children with BBD. Quality of life assessment should be considered when evaluating interventions for BBD, as it appears to be an important clinical outcome with which to determine urotherapy success.
Authors: Peng Chao Xu; Yi He Wang; Qing Jun Meng; Yi Bo Wen; Jing Yang; Xi Zheng Wang; Yan Chen; Yu Lin He; Qing Wei Wang; Yan Wang; Lin Gang Cui; Jennifer D Sihoe; Israel Franco; Jing He Lang; Jian Guo Wen Journal: Sci Rep Date: 2021-06-11 Impact factor: 4.379