Wet-day frequency improved during 12 weeks of bowel management among pediatric patients with bladder and bowel dysfunction, while adding standard urotherapy at treatment initiation was not associated with additional improvement, according to a randomized clinical trial published in JAMA Network Open.
Current pediatric continence guidelines generally recommend treating constipation before initiating bladder-directed therapies, although high-quality evidence supporting that treatment sequence has been limited.
The multicenter, open-label trial enrolled 94 patients aged 5 to 14 years at five outpatient pediatric clinics in Denmark. Eligible patients had functional constipation meeting at least two Rome IV criteria and daytime urinary incontinence at least twice weekly for at least 1 month. Patients with prior or current urotherapy or pharmacologic treatment for daytime urinary incontinence were excluded, although patients receiving laxative monotherapy could enroll if constipation remained uncontrolled.
Bladder and bowel dysfunction affects up to 20% of 7-year-olds and accounts for approximately 40% of pediatric urology referrals, according to the study background. The condition has been associated with urinary tract infections, kidney scarring, and psychosocial burden.
Patients were randomly assigned to 12 weeks of bowel management alone or bowel management plus standard urotherapy. Bowel management included disimpaction, maintenance laxative therapy, toileting following meals, and caregiver education. Standard urotherapy included education, timed voiding with timer-watch support, optimal toilet posture, and fluid intake guidance.
The primary outcome was wet days per week, assessed using the Dry Pie bladder diary and analyzed as model-derived estimates of expected wet days per week. Outcome assessment relied on patient-completed bladder diaries in an unblinded study design. Eleven randomized patients did not complete follow-up, although attrition was balanced between groups.
Of the 94 randomized patients, 83 completed follow-up and were included in the modified intention-to-treat analysis. At baseline, the estimated daily risk of a wet day was 75%. Following 12 weeks, the risk was 54% with bowel management alone and 55% with combination therapy. Expected wet days per week decreased from 5.3 at baseline to 3.8 with bowel management alone and 3.9 with combination therapy.
A reduction of at least 50% in weekly wet days occurred in 16 of 42 patients receiving bowel management alone and 12 of 41 receiving combination therapy. Complete response, defined as no wet days during the diary week, occurred in six patients receiving bowel management alone and four receiving combination therapy. Despite improvement, most patients continued to experience wet days at 12 weeks.
Incontinence severity scores also improved in both groups, with no between-group difference observed. Mean scores declined from 8.2 at baseline to 5.8 at follow-up with bowel management alone and from 7.6 to 5.5 with combination therapy.
In a post hoc exploratory analysis pooling both treatment groups, patients whose constipation resolved had 0.89 fewer wet days per week following adjustment for baseline wet days compared with patients without constipation resolution. The researchers noted that unadjusted analyses were not statistically significant.
Among patients assigned to standard urotherapy, 81% continued therapy at follow-up, although only 39% reported full adherence. Wet-day risk did not differ substantially across full-, partial-, or no-adherence groups. The researchers noted that patients who discontinued urotherapy may have had milder symptoms and lower motivation to continue therapy, potentially confounding adherence-stratified comparisons.
Fecal incontinence decreased, rectal diameter tended to decrease, and Bristol Stool Scale scores and voiding frequency remained largely unchanged. Fluid intake increased among patients assigned to standard urotherapy, consistent with the intervention. No unexpected or clinically significant adverse events occurred, although no formal adverse-event analyses were performed.
The researchers cautioned that the trial lacked an untreated control group and a standard-urotherapy-only arm. As a result, observed improvement may partly reflect placebo effects, spontaneous improvement over time, or regression to the mean. The investigators also noted the relatively short 12-week follow-up, which may help explain the lower response rates compared with prior studies reporting longer-term outcomes.
“These findings underscore the importance of adequately treating constipation as a prerequisite for optimizing the effect of standard urotherapy,” wrote lead study author Sofie Axelgaard, MD, of Gødstrup Hospital, Aarhus University, and NIDO, Centre for Research and Education, in Denmark, and colleagues.
The researchers reported no conflicts of interest.
Source: JAMA Network Open