A randomized, crossover trial comparing the efficacy and safety of fesoterodine and extended-release oxybutynin in children with overactive bladder with 12-month extension on fesoterodine: The FOXY study
Bibliographic record
Abstract
INTRODUCTION: We sought to assess and compare safety and efficacy of fesoterodine and oxybutynin extended-release in the treatment of pediatric overactive bladder (OAB). METHODS: We conducted a non-inferiority, randomized, double-blind, crossover trial comparing fesoterodine 4-8 mg and oxybutynin 10-20 mg once daily (QD) in children with OAB aged 5-14 years (2015-2018). Every child received the first medication for eight weeks, followed by crossover to the second antimuscarinic after a three-days washout. Dose up-titration was possible at mid-course. Patients could enter a fesoterodine 12-month extension. Endpoints were assessed through changes on voiding diaries, Patient's Perception of Bladder Condition score (PPBC), adverse events, vital signs, electrocardiogram, post-void residual, urinalysis, and blood tests. The Wilcoxon rank sum and Wilcoxon signed rank tests were used for statistical analysis. RESULTS: A total of 62 patients were randomized (two early dropouts). Expected class effects (dry mouth/constipation) were present but no significant difference was observed. There was a 10.1 beats/minute increase in heart rate with fesoterodine (p<0.01) (oxybutynin-1.9 beats/min; p=non-significant [ns]). No life-threatening or serious adverse events occurred. Efficacy was similar for both drugs. Bladder capacity improved over the 16 months of the study; baseline capacity of 125 mL (44.5% expected bladder capacity for age [%EBC]) to 171 mL (53.9 %EBC) at the end of the extension phase. No clinical or statistical difference was shown between efficacy measures for fesoterodine or oxybutynin. CONCLUSIONS: The use of fesoterodine or oxybutynin appear safe and effective for the treatment of OAB in children. Based on our study, long-term treatment to achieve the ultimate goal of urinary continence is needed in this population.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".