Iltamiocel cell therapy in women with recurrent or persistent stress urinary incontinence: Evidence from two double-blind, randomized, placebo-controlled trials
Bibliographic record
Abstract
Recurrent or persistent female stress urinary incontinence (SUI) following prior surgery represents an unmet medical need and a significant clinical challenge for physicians. To report the integrated clinical experience from placebo-controlled studies of iltamiocel, an investigational autologous muscle cell therapy, in women with a history of prior SUI surgery. Results from two multicenter, randomized, placebo-controlled studies of iltamiocel were pooled. Efficacy assessments were based on change from baseline to 12 months in number of SUI episodes, quality of life, and symptom severity. A total of 92 female participants, 61 iltamiocel and 31 placebo, were enrolled. At 12 months after injection, a significantly greater proportion of iltamiocel-treated participants achieved ≥ 75% reduction in SUI episodes compared with placebo (44.3% vs 16.1%, p=0.007). This treatment response was maintained out to 24 months in 84.2% of iltamiocel participants. In addition, significant differences were observed at 12 months between iltamiocel and placebo responders for the Incontinence Impact Questionnaire-7 (-31.7 vs -15.2; p=0.038) and the Severity Index for Urinary Incontinence in Women (-2.8 vs -0.3; p=0.011). No serious adverse reactions related to iltamiocel were reported. Adverse events related to the treatment procedures were reported in 6 (9.8%) iltamiocel participants and 4 (16.1%) placebo participants. Iltamiocel demonstrates significant and sustained efficacy in reducing SUI episodes and improving quality of life in women with recurrent or persistent SUI following prior surgical interventions. It offers a safe, effective and minimally invasive treatment option, addressing the need for robust management strategies in this challenging patient population.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.008 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".