1524 AUTOLOGOUS MUSCLE-DERIVED CELLS AS THERAPY FOR STRESS URINARY INCONTINENCE: A RANDOMIZED, DOSE-RANGING TRIAL

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence - Evaluation & Therapy I1 Apr 20101524 AUTOLOGOUS MUSCLE-DERIVED CELLS AS THERAPY FOR STRESS URINARY INCONTINENCE: A RANDOMIZED, DOSE-RANGING TRIAL Lesley Carr, Sender Herschorn, Colin Birch, Magnus Murphy, Magali Robert, Ronald Jankowski, Ryan Pruchnic, David Wagner, and Michael Chancellor Lesley CarrLesley Carr Toronto, Canada More articles by this author , Sender HerschornSender Herschorn Toronto, Canada More articles by this author , Colin BirchColin Birch Calgary, Canada More articles by this author , Magnus MurphyMagnus Murphy Calgary, Canada More articles by this author , Magali RobertMagali Robert Calgary, Canada More articles by this author , Ronald JankowskiRonald Jankowski Pittsburgh, PA More articles by this author , Ryan PruchnicRyan Pruchnic Pittsburgh, PA More articles by this author , David WagnerDavid Wagner Pittsburgh, PA More articles by this author , and Michael ChancellorMichael Chancellor Royal Oak, MI More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.2368AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES This is an updated report of a pilot study designed to evaluate the 12-month safety and preliminary effectiveness of autologous muscle-derived cell (AMDC) injection for the treatment of stress urinary incontinence (SUI). METHODS This study was sponsored by Cook MyoSite, Inc. and was approved by Health Canada and the institutional ethics committees. This study enrolled 38 consenting women whose SUI had not improved with conservative therapy for at least 12 months. The AMDCs were derived from biopsies of the quadriceps femoris. In the first, double-blind phase, 20 patients were randomized into 5 groups to receive 1, 2, 4, 8, or 16 million AMDCs via cystoscope-assisted periurethral cell injection. The second, single-blind phase sequentially enrolled 9 patients, 3 per group, to receive 32, 64, or 128 million AMDCs. The study was extended to include a third, single-blind phase utilizing ultrasound guidance to inject 9 patients, 3 per group, with 16, 32, or 64 million AMDCs. All patients could elect a second injection of the same dose after 3-month follow-up with assessments at 1, 3, 6 and 12 months after the last injection. RESULTS Mean patient age was 50 years (range 30-73). Of 38 patients, 32 (84.2%) elected a second injection. No serious adverse events were reported. Minor events included pain and bruising at the muscle biopsy site, mild local reactions to cell injection, mild self-limited urinary retention and urinary tract infection; 1 patient reported worsened incontinence after the second injection. To date, 29 patients have reached 12-month follow-up since their last injections (4 with 1 injection, 25 with 2 injections). Of the 25 patients with 2 injections who have reached 12-month follow-up, 16 patients (64%) had ≥ 50% reduction in the number of stress leaks over a 3-day period with 12 patients (48%) reporting no stress leaks. In addition, at 12 months after the second injection, 40% of the patients experienced ≥ 50% improvement in quality of life as measured by both IIQ-7 and UDI-6. Of the 4 patients who received a single injection and completed 12 months of follow-up, all reported ≥ 50% reduction in the number of stress leaks. Overall, a trend toward greater improvement in quality of life and stress leaks was observed for patients receiving higher doses. CONCLUSIONS Injection of AMDCs in a wide range of doses is safe for treating patients with SUI. Twelve-month results suggest acceptable effectiveness of this therapy in relieving SUI symptoms and improving quality of life. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e587-e588 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Lesley Carr Toronto, Canada More articles by this author Sender Herschorn Toronto, Canada More articles by this author Colin Birch Calgary, Canada More articles by this author Magnus Murphy Calgary, Canada More articles by this author Magali Robert Calgary, Canada More articles by this author Ronald Jankowski Pittsburgh, PA More articles by this author Ryan Pruchnic Pittsburgh, PA More articles by this author David Wagner Pittsburgh, PA More articles by this author Michael Chancellor Royal Oak, MI More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...