An evaluation of patient and physician satisfaction with controlled-release oxybutynin 15 mg as a one-step daily dose in elderly and non-elderly patients with overactive bladder: results of the STOP study
Bibliographic record
Abstract
OBJECTIVE: Evaluate patient and physician satisfaction with a novel formulation of a once-daily controlled-release (CR) oxybutynin (Uromax*) 15-mg tablet as both the initial and maintenance dose in elderly and non-elderly patients with overactive bladder (OAB). METHODS: Patients not on anticholinergic treatment for OAB and experiencing urinary incontinence (≥1 episode/week) and micturition frequency (≥8 episodes/day) or urgency (≥1 episode/week) were enrolled in this 4-week, open-label study. Satisfaction, efficacy, mental status and adverse events were evaluated by urologists, gynecologists, urogynecologists and family practitioners. The analyses compared the outcomes in patients <65 and ≥65 years. CLINICAL TRIAL REGISTRATION: ISRCTN 19242032. RESULTS: A total of 240 patients enrolled; 111 (46%) were ≥65 years of age. Completion rate was 76.0% (<65) and 62.2% (≥65) (p = 0.0204). Medication was rated as tolerable by 75.2% of patients <65 and 58.6% of patients ≥65 (p = 0.0099). Based on overall satisfaction scores 64.2% (patient scores) and 57.1% (physician scores) of patients were considered 'successfully treated' (p = 0.0001 & p = 0.0451). There was a significant reduction in incontinence (64.3%; p = 0.0001), nocturia (38.6%; p = 0.0001) and night-time incontinence (39.7%; p = 0.0436) with no difference between age groups. Total continence was achieved by 29.8% and 47.5% of patients <65 and ≥65, respectively (p = 0.0077). No patients clinically experienced confusion or delirium and only six patients ≥65 had a decrease in MMSE score of ≥3 units, which was not statistically different from patients <65 (p = 0.3112). Dry mouth was the most common adverse event reported by 24.8% of patients <65 and 36.0% of patients ≥65 (p = 0.0584). Limitations of the study include a fixed dosing, no control group and 4-week trial. CONCLUSION: Patients and physicians were satisfied with CR oxybutynin 15 mg once-daily. Patients tolerated the CR oxybutynin 15 mg as both the initial and maintenance dose and provided significant reductions in incontinence, nocturia and night-time incontinence without a significant change in cognitive status. Total continence rates were significantly superior in patients ≥65 and there was no difference in dry mouth, cognitive status or efficacy in patients <65 and ≥65.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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) | 0.002 | 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 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".