415 The Importance of Proper Placebo-Control in Sexual Medicine Medical Device Trials
Bibliographic record
Abstract
To evaluate the placebo effect for a medical device that uses monopolar radiofrequency (RF) with cooling when treating women experiencing symptoms of sexual dysfunction and to assess the importance of inclusion of an appropriate placebo control in clinical trials for women’s health. A prospective, longitudinal, randomized, blinded, placebo-controlled, multi-center clinical study was conducted for the treatment of sexual dysfunction with vaginal introital laxity as a primary symptom. The treatment is an outpatient monopolar RF procedure that couples energy administration to heat underlying tissue while cooling and protecting the vaginal mucosa. Efficacy and safety have been published elsewhere. This international study is the first and only of its kind ever done for RF treatment for sexual dysfunction. Subjects were randomized in a 2:1 ratio to either the active (90 J/cm2) or sham (≤1 J/cm2) treatment groups. Nine sites were chosen in multiple countries (Italy, Spain, Canada and Japan). Subjects were followed up at 72 hrs., 10 days, and 1, 2, 3, and 6 months post-treatment. Patient reported outcomes included the Female Sexual Function Index (FSFI) and a 7-point Likert scale assessment for vaginal laxity.
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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 | 0.388 | 0.357 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.004 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.002 | 0.006 |
| Scholarly communication | 0.006 | 0.007 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.014 | 0.006 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".