Autologous Muscle Derived Cell Therapy for Stress Urinary Incontinence: A Prospective, Dose Ranging Study
Bibliographic record
Abstract
PURPOSE: In this feasibility study we assessed the 12-month safety and potential efficacy of autologous muscle derived cells (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) as therapy for stress urinary incontinence. MATERIALS AND METHODS: A total of 38 women in whom stress urinary incontinence had not improved with conservative therapy for 12 or more months underwent intrasphincter injection of low doses (1, 2, 4, 8 or 16 × 10(6)) or high doses (32, 64 or 128 × 10(6)) of autologous muscle derived cells, which were derived from biopsies of their quadriceps femoris. All patients could elect a second treatment of the same dose after 3-month followup. Assessments were made at 1, 3, 6 and 12 months after the last treatment. The primary end point was the incidence and severity of adverse events. In addition, changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys. RESULTS: Of the 38 patients 33 completed the study. Treatment related complications were limited to minor events such as pain/bruising at the biopsy and injection sites. Of patients who received 2 treatments of autologous muscle derived cells who were eligible for analysis, a higher percentage of those in the high dose vs the low dose group experienced a 50% or greater reduction in pad weight (88.9%, 8 of 9 vs 61.5%, 8 of 13), had a 50% or greater reduction in diary reported stress leaks (77.8%, 7 of 9 vs 53.3%, 8 of 15) and had 0 to 1 leaks during 3 days (88.9%, 8 of 9 vs 33.3%, 5 of 15) at final followup. CONCLUSIONS: Injection of autologous muscle derived cells in a wide range of doses appears safe with no major treatment related adverse events reported. In addition, treatment with autologous muscle derived cells shows promise for relieving stress urinary incontinence symptoms and improving quality of life.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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; 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".