A Pilot Randomized Controlled Trial Evaluating the Effectiveness of Group vs Individual Urotherapy in Decreasing Symptoms Associated with Bladder-Bowel Dysfunction
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.
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.
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.
- 1 : The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children’s Continence Society. J Urol2006; 176: 314. Link, Google Scholar
- 2 : A population based study of 2,856 school-age children with urinary incontinence. J Urol2009; 181: 808. Link, Google Scholar
- 3 : Management of daytime urinary incontinence and lower urinary tract symptoms in children. J Paediatr Child Health2012; 48: E44. Google Scholar
- 4 : Treatment outcome of day-time urinary incontinence in children. Scand J Urol Nephrol2008; 42: 528. Google Scholar
- 5 : Prospective evaluation of inpatient and outpatient bladder training in children with functional urinary incontinence. Urology2006; 67: 176. Google Scholar
- 6 : Urotherapy in children: quantitative measurements of daytime urinary incontinence before and after treatment according to the new definitions of the International Children’s Continence Society. J Pediatr Urol2011; 7: 213. Google Scholar
- 7 : Voiding school for children with idiopathic urinary incontinence and/or bladder dysfunction. J Pediatr Urol2010; 6: 490. Google Scholar
- 8 : Long-term efficacy of simple behavioral therapy for daytime wetting in children. J Urol2000; 164: 786. Link, Google Scholar
- 9 : Twenty years of urotherapy in children: what have we learned?. Eur Urol2006; 49: 426. Google Scholar
- 10 : Half-day urotherapy improves voiding parameters in children with dysfunctional emptying. Eur Urol2006; 49: 570. Google Scholar
- 11 : Coping, commitment, and attitude: quantifying the everyday burden of enuresis on children and their families. Pediatrics2004; 113: 334. Google Scholar
- 12 : Self-reported effect of childhood incontinence on quality of life. J Wound Ostomy Continence Nurs2008; 35: 617. Google Scholar
- 13 : Development of a symptom score for dysfunctional elimination syndrome. J Urol2009; 182: 1939. Link, Google Scholar
- 14 : PinQ: a valid, reliable and reproducible quality-of-life measure in children with bladder dysfunction. J Pediatr Urol2006; 2: 185. Google Scholar
- 15 : The role of randomized controlled trials in evidence-based urology. World J Urol2011; 29: 257. Google Scholar
- 16 : Randomized controlled trials in pediatric urology: room for improvement. J Urol2006; 176: 306. Link, Google Scholar
- 17 : Prospective evaluation of clinical voiding reeducation or voiding school for lower urinary tract conditions in children. J Urol2011; 186: 648. Link, Google Scholar
- 18 : Dysfunctional elimination symptoms in childhood and adulthood. J Urol2005; 174: 1623. Link, Google Scholar
- 19 : A 20-year study of persistence of lower urinary tract symptoms and urinary incontinence in young women treated in childhood. J Pediatr Urol2014; 10: 441. Google Scholar