Multi-center randomized controlled trial of cognitive treatment, placebo, oxybutynin, bladder training, and pelvic

Jan D van Gool1, Tom P V M de Jong, Pauline Winkler-Seinstra

  • 1Institute for Medical Informatics, Biometry and Epidemiology, Essen-Duisburg University, Essen, Germany; Pediatric Renal Center, WKZ/UMC, Utrecht, The Netherlands.

Insights

Cognitive treatment, not added interventions, successfully treated childhood incontinence by addressing symptom-urodynamic mismatches. Social stress may underlie symptoms, potentially mediated by specific signaling pathways.

Area of Science:

  • Pediatric Urology
  • Behavioral Medicine
  • Clinical Trials

Background:

  • Functional urinary incontinence affects 8.4% of school-aged children, predominantly girls, causing significant morbidity.
  • Overactive bladder (OAB) and dysfunctional voiding (DV) are common diagnoses associated with childhood incontinence.

Purpose of the Study:

  • To compare the efficacy of oxybutynin, placebo, and bladder training for OAB.
  • To evaluate cognitive treatment versus pelvic floor training for DV in children.
  • To investigate the role of urodynamic studies in diagnosing and managing childhood incontinence.

Main Methods:

  • A multi-center controlled trial randomized children with OAB or DV to different treatment arms.
  • Interventions included oxybutynin, bladder training, cognitive treatment, and pelvic floor training, with all children receiving standardized cognitive treatment.
  • Urodynamic studies were conducted pre- and post-treatment to assess bladder and pelvic floor activity.

Main Results:

  • For OAB, cure rates were similar across placebo (39%), oxybutynin (43%), and bladder training (44%).
  • For DV, cure rates were 52% for controls and 49% for pelvic floor training.
  • Pre-treatment urodynamic patterns did not correlate with clinical diagnoses, and new patterns emerged post-treatment in at least 20% of cases.

Conclusions:

  • Cognitive treatment emerged as the primary driver of success, highlighting a mismatch between clinical symptoms and urodynamic findings.
  • The unpredictable nature of urodynamic changes and treatment response suggests underlying factors beyond simple bladder or pelvic floor dysfunction.
  • Gender-specific prevalence and the impact of cognitive treatment point towards social stress, potentially mediated by corticotropin-releasing factor pathways, as a significant contributing factor to childhood incontinence.
Abstract

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