A Comparative Randomized Cross-Over Trial to Examine Efficacy of Urine Capture and Comfort of Two Male External Urine Collection Devices in Healthy Male Volunteers
Bibliographic record
Abstract
PURPOSE: This study assessed the efficiency of urine collection using external urine collection devices over two voids in a group of morbidly obese and non-obese men. DESIGN: Prospective single-blind comparative crossover study. MATERIALS AND METHOD: We assessed the comparative urine capture efficiency of two commercially available male external urine management systems. Continent consenting men were randomized to use each device for a single void. The proportion of urine captured by each device expressed as a percentage of the total volume voided in grams was calculated and compared. Results were compared between morbidly obese (BMI ≥ 40 kg/m2) and non-morbidity (BMI ≤ 40 kg/m2) men. RESULTS: Fifty-nine men completed the study; their mean (standard deviation, SD) age was 40.8 (SD 12.4) years. For void 1, the mean proportion of urine capture for Device A was 97.8% (SD 10.0); for Device B it was 90.7% (SD 20.7). For void 2, the mean proportion of urine capture for Device A was 91.1% (SD 25.8); for Device B it was 85.2% (SD 21.7). The mean difference between devices was 6.6% (95% CI 0.18, 13.0), P = .044. Stratified by weight, in the morbidly obese men, Device A captured 99.7% (SD 0.88) of the first void versus 83.5% (SD 32.2) for Device B. Analysis of the second voids found that Device A captured 80.8% (SD 36.9) versus 79.3% (SD 23.3) for Device B. CONCLUSION: Device A (the investigational device) performed significantly better than Device B in capture rates when compared based on voided volume, order of void, or BMI category. Device A male external catheter system is an effective option for urine management in both obese and non-obese men.
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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 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 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".