1655 LONG-TERM EFFICACY AND SAFETY OF ONABOTULINUMTOXINA IN PATIENTS WITH URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY
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Résumé
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 ...
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».