A Pilot Randomized Controlled Trial Evaluating the Effectiveness of Group vs Individual Urotherapy in Decreasing Symptoms Associated with Bladder-Bowel Dysfunction
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PURPOSE: We determined the feasibility of a definitive trial comparing the effectiveness of group vs individual urotherapy for children with bladder-bowel dysfunction. MATERIALS AND METHODS: Children 6 to 10 years old with bladder-bowel dysfunction were recruited during the course of 1 year. Feasibility data on screening, eligibility, recruitment and protocol compliance rates were collected. Patients with high grade hydronephrosis, vesicoureteral reflux or learning disabilities and those who had previously undergone urotherapy were excluded. Patients were randomized to 1-hour group urotherapy or 15-minute individual urotherapy. Symptoms and quality of life were measured using the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire and the Pediatric Incontinence Questionnaire at baseline and at 3 to 6 months of followup. Within/between group comparisons were conducted using t-tests. RESULTS: Of 455 screened children 79 were eligible and 60 were recruited to participate. A total of 24 patients randomized to group urotherapy and 25 randomized to individual urotherapy completed the pilot trial (6 undergoing group and 5 undergoing individual urotherapy withdrew from the study). Symptomology scores between group and individual urotherapy were not different at followup (mean ± SD 14.7 ± 7.9 vs 13.4 ± 6.3, p = 0.54, 95% CI -5.4-2.8). Quality of life scores between patients undergoing group and individual urotherapy at baseline differed (mean ± SD 21.1 ± 10.8 vs 31.0 ± 14.3, p < 0.01, 95% CI 2.7-7.3) but became similar at followup (21.0 ± 14.2 vs 20.1 ± 15.3, p = 0.84, 95% CI -9.4-7.6). Within group analyses demonstrated improvement in symptomology from baseline to followup in patients undergoing group (mean ± SD 3.6 ± 7.6, p = 0.03, 95% CI 0.4-6.8) and individual urotherapy (6.0 ± 5.4, p < 0.01, 95% CI 3.8-8.3). Within group quality of life analyses revealed improvement in Pediatric Incontinence Questionnaire scores from baseline to followup in patients undergoing individual urotherapy (p < 0.01, 95% CI 5.0-16.9) only. CONCLUSIONS: Urotherapy, regardless of modality, effectively improved bladder-bowel dysfunction symptoms. A definitive randomized controlled trial is feasible, considering that a high recruitment rate (76%) for this population has been established.
