A Double-Blind, Randomized, Controlled Trial Comparing Safety And Efficacy Of Autologous Muscle Derived Cells For Urinary Sphincter Repair (Amdc-Usr) With Placebo (Pbo) In Women With Stress Urinary Incontinence (Sui)

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (PD06)1 Sep 2021PD06-01 A DOUBLE-BLIND, RANDOMIZED, CONTROLLED TRIAL COMPARING SAFETY AND EFFICACY OF AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR (AMDC-USR) WITH PLACEBO (PBO) IN WOMEN WITH STRESS URINARY INCONTINENCE (SUI) Melissa R. Kaufman, Kenneth M. Peters, Christopher J. Chermansky, Lieschen H. Quiroz, Jason B. Bennett, Sherry Thomas, Howard B. Goldman, Kevin D. Benson, Roger R. Dmochowski, Una J. Lee, Eric R. Sokol, Niall T.M. Galloway, Christopher E. Wolter, Michael J. Kennelly, Christopher M. Tarnay, Michael H. Heit, Christian Rehme, Ron J. Jankowski, and Michael B. Chancellor Melissa R. KaufmanMelissa R. Kaufman More articles by this author , Kenneth M. PetersKenneth M. Peters More articles by this author , Christopher J. ChermanskyChristopher J. Chermansky More articles by this author , Lieschen H. QuirozLieschen H. Quiroz More articles by this author , Jason B. BennettJason B. Bennett More articles by this author , Sherry ThomasSherry Thomas More articles by this author , Howard B. GoldmanHoward B. Goldman More articles by this author , Kevin D. BensonKevin D. Benson More articles by this author , Roger R. DmochowskiRoger R. Dmochowski More articles by this author , Una J. LeeUna J. Lee More articles by this author , Eric R. SokolEric R. Sokol More articles by this author , Niall T.M. GallowayNiall T.M. Galloway More articles by this author , Christopher E. WolterChristopher E. Wolter More articles by this author , Michael J. KennellyMichael J. Kennelly More articles by this author , Christopher M. TarnayChristopher M. Tarnay More articles by this author , Michael H. HeitMichael H. Heit More articles by this author , Christian RehmeChristian Rehme More articles by this author , Ron J. JankowskiRon J. Jankowski More articles by this author , and Michael B. ChancellorMichael B. Chancellor More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001974.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: This multicenter Phase 3 study (NCT01893138) evaluated efficacy and safety of AMDC-USR compared to PBO for SUI treatment. METHODS: 297 adult women with average 14.4 ± 11.4 stress leaks over 3 days were randomized 2:1 (150x106 AMDC-USR:vehicle PBO) and stratified by baseline severity and prior SUI surgery. AMDC-USR was manufactured from vastus lateralis harvest via outpatient biopsy and injected into the urinary sphincter at a subsequent outpatient procedure. SUI was monitored by 3-day diary of stress incontinence episode frequency (SIEF) and quality of life (QOL) questionnaires. Subjects were unblinded after 12 months, and PBO subjects could receive an open-label AMDC-USR treatment. Subjects were followed for 2 years post initial treatment. RESULTS: 297 women were treated (199 AMDC-USR; 98 PBO), 99% completed 12 months (199 AMDC-USR; 96 PBO), and 85% have completed 2 years (167 AMDC-USR; 86 PBO). 93% PBO subjects opted to receive open-label AMDC-USR treatment. Percentage of SIEF responders by strata, endpoints and visits is presented below. SIEF reduction correlated with improvement in all QOL scores at 12 months (p < 0.001). Treatment-related serious adverse reactions were uncommon (< 1%) with no AMDC-USR safety signals detected. CONCLUSIONS: Single injection of AMDC-USR is safe and durable through 2 years with varying therapeutic effect. Consistent with our previous study, ≥ 50% SIEF reduction is not a sufficient endpoint. High variability in PBO response rates across strata impacts generalizability of the treatment response in the overall population. Nonetheless, there was encouraging response in subjects with > 10 baseline SIE, and a markedly greater percentage (> 2-fold) of women with prior surgery achieved statistical and clinically meaningful ≥ 75% SIEF reduction compared with PBO, further supporting that this population may be ideally suited for AMDC-USR therapy. Source of Funding: Cook MyoSite Incorporated © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e99-e99 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Melissa R. Kaufman More articles by this author Kenneth M. Peters More articles by this author Christopher J. Chermansky More articles by this author Lieschen H. Quiroz More articles by this author Jason B. Bennett More articles by this author Sherry Thomas More articles by this author Howard B. Goldman More articles by this author Kevin D. Benson More articles by this author Roger R. Dmochowski More articles by this author Una J. Lee More articles by this author Eric R. Sokol More articles by this author Niall T.M. Galloway More articles by this author Christopher E. Wolter More articles by this author Michael J. Kennelly More articles by this author Christopher M. Tarnay More articles by this author Michael H. Heit More articles by this author Christian Rehme More articles by this author Ron J. Jankowski More articles by this author Michael B. Chancellor More articles by this author Expand All Advertisement Loading ...