Double-blind randomized controlled trial of Er: YAG vaginal laser to treat female stress urinary incontinence
Bibliographic record
Abstract
BACKGROUND: Stress urinary incontinence affects approximately 40% of adult females and is often treated surgically. Minimally invasive vaginal laser therapy to treat stress urinary incontinence has become widely available, but the efficacy of this novel therapy is unclear. OBJECTIVE: This study aimed to determine the efficacy of erbium-doped yttrium aluminum garnet laser as a therapy for stress urinary incontinence. STUDY DESIGN: This was a double-blind randomized sham-controlled trial with 6-week and 6-month follow-ups at a single tertiary hospital setting with 144 adult female patients with symptomatic stress urinary incontinence. Each participant received 2 vaginal laser therapies 6 weeks apart, with patients randomized to either laser or sham. The primary outcome was patients' subjective reporting of no urinary incontinence at 6 months after treatment on question 3 of the International Consultation on Incontinence Questionnaire-Short Form. The secondary outcomes included objective measures of urine loss with 24-hour pad tests, 3 incontinence symptom questionnaires (Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and International Consultation on Incontinence Questionnaire-Short Form), 1 quality-of-life questionnaire (King's Health Questionnaire), and 1 sexual function questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). RESULTS: Of 263 individuals approached, 76 of 144 individuals were randomized to the laser treatment group, and 68 of 144 individuals were randomized to the sham treatment group. There was no difference in the reported cure rate and the primary outcome at 6 months after treatment between the groups (laser treatment group: 0.0136; 95% confidence interval, 0.0006-0.0811; sham treatment group: 0.0000; 95% confidence interval, 0.0000-0.0666). Apart from a statistically significant difference noted at 6 weeks after treatment in 1 of 3 incontinence questionnaires and 3 of 9 domains of the quality-of-life questionnaire, there were no other significant differences in our subjective or objective measures between the 2 groups at 6 weeks and 6 months after treatment. CONCLUSION: Er: YAG laser was no more effective than sham for curing or improving female stress urinary incontinence at 6 months.
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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 | 0.005 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.017 | 0.002 |
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".