1655 LONG-TERM EFFICACY AND SAFETY OF ONABOTULINUMTOXINA IN PATIENTS WITH URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY
Bibliographic record
Abstract
You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Neurogenic Voiding Dysfunction1 Apr 20121655 LONG-TERM EFFICACY AND SAFETY OF ONABOTULINUMTOXINA IN PATIENTS WITH URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY Michael Kennelly, Roger Dmochowski, Karen Ethans, Gilles Karsenty, Gary Lemack, Heinrich Schulte-Baukloh, Brenda Jenkins, Catherine Thompson, Daniel Li, and Cornelia Haag-Molkenteller Michael KennellyMichael Kennelly Charlotte, NC , Roger DmochowskiRoger Dmochowski Nashville, TN , Karen EthansKaren Ethans Winnipeg, Canada , Gilles KarsentyGilles Karsenty Marseille, France , Gary LemackGary Lemack Dallas, TX , Heinrich Schulte-BauklohHeinrich Schulte-Baukloh Berlin, Germany , Brenda JenkinsBrenda Jenkins Irvine, CA , Catherine ThompsonCatherine Thompson Irvine, CA , Daniel LiDaniel Li Irvine, CA , and Cornelia Haag-MolkentellerCornelia Haag-Molkenteller Irvine, CA View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1487AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES This is an interim analysis of the long-term extension study of the 2 phase 3, randomized, placebo-controlled studies of onabotulinumtoxinA (onabotA). Both studies demonstrated that onabotA significantly decreases urinary incontinence (UI) episodes and improves urodynamics and quality of life (QOL) in patients (pts) with UI due to neurogenic detrusor overactivity (NDO) who were not adequately managed with anticholinergics. The objective of the extension study is to evaluate efficacy and safety of onabotA in these pts over repeat injection cycles. METHODS Pts who completed the phase 3 studies could enter the 3-year extension study and receive multiple treatments of intradetrusor onabot A 200 U or 300 U (administered via cystoscopy, avoiding the trigone). Data were integrated across the studies, and all pts who received ≥1 onabotA treatment in either the phase 3 studies or long-term extension study were included; data were analyzed by onabotA treatment cycle (up to 5 cycles). Change from baseline (BL; before any treatment) in weekly UI episodes at 6 wks after each treatment was the endpoint of primary interest. Additional endpoints at Wk 6 included ≥50% and 100% reductions in UI episodes, Incontinence-QOL (I-QOL) questionnaire responder rates (proportion of pts achieving an ≥11-point increase from BL in I-QOL score), total volume/void, and adverse events (AEs). RESULTS A total of 387, 336, 241, 113, and 46 patients received 1, 2, 3, 4, and 5 onabotA treatments. UI episodes/wk were consistently reduced compared to BL following repeated onabotA treatment; reductions from BL were -22.7, -23.3, -23.1, -25.3, and -31.9 for onabotA 200U and -23.8, -25.0, -23.6, -24.1, and -29.5 for onabotA 300U at Wk 6 in treatment cycles 1 through 5, respectively (P<0.001 vs BL). The proportion of pts reporting ≥50% reductions from BL in UI episodes and 100% reduction in UI episodes ("dry") at Wk 6 ranged from 73-94% and 36-55%, respectively, across the 5 treatment cycles. A consistent response was also observed in the I-QOL responder rates over repeated cycles (66-93%). The most common AEs were localized urological events (urinary tract infections and urinary retention), and there was no change in the AE profile over time. CONCLUSIONS Sustained reductions in UI episodes and improvements in QOL were observed over repeated onabotA treatments (up to 5 cycles) in pts with UI due to NDO who were inadequately managed with anticholinergics. No new safety signals were observed with repeat treatment. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e668-e669 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Kennelly Charlotte, NC More articles by this author Roger Dmochowski Nashville, TN More articles by this author Karen Ethans Winnipeg, Canada More articles by this author Gilles Karsenty Marseille, France More articles by this author Gary Lemack Dallas, TX More articles by this author Heinrich Schulte-Baukloh Berlin, Germany More articles by this author Brenda Jenkins Irvine, CA More articles by this author Catherine Thompson Irvine, CA More articles by this author Daniel Li Irvine, CA More articles by this author Cornelia Haag-Molkenteller Irvine, CA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".