A pilot randomized‐controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction
Bibliographic record
Abstract
Aims To determine the effectiveness of mirabegron in patients with neurogenic lower urinary tract dysfunction. Methods Randomized, double‐blind, placebo‐controlled study. Canadian patients with spinal cord injury (SCI) or multiple sclerosis (MS) with urinary symptoms and incontinence were recruited. Patients were randomized to mirabegron 25 mg (or an identical placebo) for 2 weeks at which point a dose escalation to mirabegron 50 mg (or an identical placebo) was maintained for 8 weeks. Urodynamics were performed before and after treatment. The primary outcome measure was maximum cystometric capacity (MCC). Intention to treat analysis and ANCOVA models (with adjustment for baseline values) were used and marginal means (MM) are reported; P ‐value <0.05 was considered significant. Results Sixteen (9 SCI and 7 MS) patients were randomized to mirabegron and 16 (10 SCI and 6 MS) to placebo. At study completion, there was no significant difference in MCC between mirabegron and placebo (MM 305 vs 369 mL, P = 0.20). There was no significant difference in volume at first neurogenic detrusor overactivity (NDO, MM 167 vs 137 mL, P = 0.14) and peak pressure of NDO (MM 69 vs 82 cmH 2 O, P = 0.25). There was no significant difference in pad weights or voiding diary parameters. There was a significantly lower symptom burden among those treated with mirabegron (total neurogenic bladder symptom score MM 29 vs 34, P = 0.047). Conclusions Among patients with SCI or MS, we demonstrated non‐significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".