Bowel Management and Standard Urotherapy in Pediatric Bladder and Bowel Dysfunction: A Randomized Clinical Trial

Bladder and bowel dysfunction is a common pediatric condition characterized by functional constipation and lower urinary tract symptoms, including daytime urinary incontinence. It increases the risk of urinary tract infections and kidney damage and imposes substantial psychosocial burden. High-quality evidence regarding optimal sequencing of bowel and bladder interventions is limited.

To examine whether adding standard urotherapy to bowel management further reduces daytime urinary incontinence in children with bladder and bowel dysfunction.

This multicenter, open-label, parallel-group randomized clinical trial was conducted from September 1, 2022, to July 31, 2025, with 12-week follow-up at 5 outpatient pediatric clinics in Denmark. Children aged 5 to 14 years with treatment-naive bladder and bowel dysfunction were included in the modified intention-to-treat analysis.

Twelve weeks of bowel management alone (monotherapy) or combined with standard urotherapy (combination therapy). Bowel management included disimpaction and maintenance therapy, toileting after meals, and caregiver education. Urotherapy included education, timed voiding, optimal toilet posture, and fluid intake guidance.

The primary outcome was wet days per week, assessed by the Dry Pie bladder diary and reported as (1) risk of a wet day, (2) expected number of wet days per week, and (3) response rates: no (<50%), partial (50%-99%), or complete (100%) response.

Ninety-four children (median [IQR] age, 6.9 [6.1-8.2] years; 57 [60.6%] male) were randomized; 83 completed follow-up. At baseline, the daily risk of a wet day was 0.75 (95% CI, 0.70-0.80). After 12 weeks, risks were 0.54 (95% CI, 0.44-0.65) for monotherapy and 0.55 (95% CI, 0.45-0.66) for combination therapy. Expected wet days decreased from 5.3 (95% CI, 4.9-5.6) to 3.8 (95% CI, 3.0-4.6) and 3.9 (95% CI, 3.1-4.6). The number of participants achieving a 50% or greater reduction in the number of wet days per week was 16 (38.1%; 95% CI, 23.6%-54.4%) in the monotherapy group and 12 (29.3%; 95% CI, 16.1%-45.5%) in the combination therapy group. Complete response was achieved by 6 (14.3%; 95% CI, 5.4%-28.5%) in the monotherapy group and 4 (9.8%; 95% CI, 2.7%-23.1%) in the combination therapy group. Constipation resolution was associated with larger reductions (expected 3.44 vs 4.15 per week; adjusted mean difference, -0.89; 95% CI, -1.94 to -0.05).

In this randomized clinical trial of children with bladder and bowel dysfunction, bowel management reduced daytime urinary incontinence; concurrent urotherapy provided no additional benefit. This finding highlights that bowel management alone was an effective first-line intervention and may be a prerequisite for successful standard urotherapy.

ClinicalTrials.gov NCT05318365.