Long-term Efficacy and Safety of OnabotulinumtoxinA in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity: An Interim Analysis
Bibliographic record
Abstract
OBJECTIVE: To evaluate the long-term efficacy and safety of repeat onabotulinumtoxinA injections in patients inadequately managed by anticholinergics for urinary incontinence (UI) due to neurogenic detrusor overactivity. MATERIALS AND METHODS: Patients who completed either of 2 preceding phase III studies were offered entry into an extension study and received repeat onabotulinumtoxinA 200 U or 300 U. The data were integrated across the phase III and ongoing extension studies. The present interim analysis included all patients who received ≥ 1 onabotulinumtoxinA treatment. The data were analyzed by treatment cycle (cycles 1-5). The primary assessment was the change from baseline in UI episodes/wk at 6 weeks after each treatment. Additional assessments included ≥ 50% and 100% reductions in UI episodes, volume/void, Incontinence Quality of Life responses, and adverse events. RESULTS: A total of 387, 336, 241, 113, and 46 patients received 1, 2, 3, 4, and 5 onabotulinumtoxinA treatments, respectively. The UI episodes/wk were consistently reduced compared with baseline after repeated onabotulinumtoxinA treatment (-22.7, -23.3, -23.1, -25.3, and -31.9 for the 200-U onabotulinumtoxinA group in cycles 1-5). The proportion of patients reporting ≥ 50% and 100% ("dry") reductions from baseline in UI episodes at week 6 ranged from 73%-94% and 36%-55%, respectively. Increases in the mean volume/void (mean increase >130 mL) and improvements in quality of life were also observed after repeat treatment. The most common adverse events were urinary tract infections and urinary retention, with no change in the adverse event profile over time. CONCLUSION: The results of our study have shown that repeated onabotulinumtoxinA treatments provide sustained reductions in UI episodes and increases in the volume/void and quality of life in patients with neurogenic detrusor overactivity and UI who were inadequately managed by anticholinergics, with no new safety signals.
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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 | 0.000 | 0.000 |
| 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 | 0.000 |
| 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".