PD50-08 AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR FOR RECURRENT OR PERSISTENT STRESS URINARY INCONTINENCE AFTER CONTINENCE SURGERY

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy II1 Apr 2017PD50-08 AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR FOR RECURRENT OR PERSISTENT STRESS URINARY INCONTINENCE AFTER CONTINENCE SURGERY Lesley Carr, Le Mai Tu, Magali Robert, David Quinlan, Kevin Carlson, Sender Herschorn, Roger Dmochowski, Kenneth Peters, Melissa Kaufman, Ron Jankowski, and Michael Chancellor Lesley CarrLesley Carr More articles by this author , Le Mai TuLe Mai Tu More articles by this author , Magali RobertMagali Robert More articles by this author , David QuinlanDavid Quinlan More articles by this author , Kevin CarlsonKevin Carlson More articles by this author , Sender HerschornSender Herschorn More articles by this author , Roger DmochowskiRoger Dmochowski More articles by this author , Kenneth PetersKenneth Peters More articles by this author , Melissa KaufmanMelissa Kaufman More articles by this author , Ron JankowskiRon Jankowski More articles by this author , and Michael ChancellorMichael Chancellor More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2220AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We describe the effect of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) on women with recurrent or persistent stress urinary incontinence (SUI) after continence surgery. METHODS Analysis includes data from women enrolled in Cook MyoSite-sponsored SUI studies who underwent prior continence surgery (e.g., urethral sling, bladder neck suspension) and presented with incontinence episode frequency (IEF) of ≥3 stress leaks over 3 days and ≥3 g 24-hour pad test. Twenty-one women who received 1 treatment of 10 (n=5), 50 (n=2), 100 (n=4), or 200 x 106 (n=10) AMDC-USR were treated in open-label studies (NCT00847535, NCT01008943) and 17 women who were randomized 2:1 to receive 150 x 106 AMDC-USR (n=11) or placebo (n=6) and 1:1 for 1 or 2 treatments were treated in a double-blind trial (RCT, NCT01382602). SUI was assessed by 3-day diaries at baseline and 1, 3, 6, and 12 months for all studies and at 2 years in the RCT. RCT patients were unblinded after 12-month visits. RESULTS Median baseline stress IEF per 3 days was 12 leaks for open-label studies, and 11 leaks for AMDC-USR and 27.5 leaks for placebo in the RCT. In the RCT, the AMDC-USR group tended to be younger (51 yr vs. 64 yr), had a lower percentage with stage 1-2 pelvic organ prolapse (9% vs. 67%), and better 24-hour pad tests (45 g vs. 76 g) than placebo. In open-label studies, 18 women completed 12-month visits; 67% (12/18) had ≥50% IEF reduction, 44% (8/18) had ≥75% IEF reduction, and 39% (7/18) reported ≤1 leak over 3 days. Similarly, 12-month responder rates for the RCT AMDC-USR group were 73% (8/11) for ≥50% IEF reduction, 64% (7/11) for ≥75% IEF reduction, and 36% (4/11) for ≤1 leak per 3 days. During the RCT, a higher percentage of the AMDC-USR group met IEF reduction endpoints than placebo (Figure). Eight AMDC-USR RCT patients completed 2-year diaries; 100% (6/6) of women with ≥50% IEF reduction at 12 months also met the endpoint at 2 years. All (6/6) RCT placebo patients elected to receive open-label AMDC-USR after unblinding; at final follow-up, 3 patients had ≥50% IEF reduction compared to 12-month diaries. No AMDC-USR safety signals were identified. CONCLUSIONS AMDC-USR may be a novel, safe, durable therapy for the challenging patient population with recurrent or persistent SUI after continence surgery. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e982 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Lesley Carr More articles by this author Le Mai Tu More articles by this author Magali Robert More articles by this author David Quinlan More articles by this author Kevin Carlson More articles by this author Sender Herschorn More articles by this author Roger Dmochowski More articles by this author Kenneth Peters More articles by this author Melissa Kaufman More articles by this author Ron Jankowski More articles by this author Michael Chancellor More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...