Poster, Podium & Video Sessions
Presentation Authors: Lesley Carr, Toronto, Canada, Le Mai Tu, Sherbrooke, Canada, Magali Robert, Calgary, Canada, David Quinlan, Victoria, Canada, Kevin Carlson, Calgary, Canada, Sender Herschorn, Toronto, Canada, Roger Dmochowski, Nashville, TN, Kenneth Peters, Royal Oak, MI
Introduction: 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.
Source Of Funding: Cook MyoSite, Incorporated
Beaumont Healt, Oakland University William Beaumot School of Medicine
Michael B Chancellor, MD
Professor of Urology, Oakland University William Beaumont School of Medicine
Director of Aikens Neurourology Research Center, Beaumont Health
Dr. Chancellor, board-certified by the American Board of Urology, received his medical degree from Medical College of Wisconsin in Milwaukee. Dr. Chancellor completed his residency in urology at the University of Michigan. He subsequently completed his fellowship in neurourology and female urology at Columbia University and College of Physicians and Surgeons in New York. Dr. Chancellor is a world-renowned author and speaker. He has appeared on CNN, in the pages of The Wall Street Journal, and in numerous television and radio interviews.
Dr. Chancellor has written over 600 peer-reviewed articles and book chapters in journals including Journal of Urology, European Urology, Gene Therapy, and Lancet. He has also written 11 books, including Botulinum Toxin in Urology. A prolific author and researcher, Dr. Chancellor has gained national and international recognition in the areas of stem cell and tissue engineering as well as drug discovery. He was one of the first urologist to use botulinum toxin to treat lower urinary tract dysfunction. His inventions founded Cook MyoSite, Inc., which is now conducting multicenter North American trials using adult autologous muscle-derived stem cells to treat stress urinary incontinence. Dr. Chancellor also founded Lipella Pharmaceuticals, Inc., a biopharmaceutical company focusing on localized therapy and advance drug delivery.
Dr. Chancellor has received a number of prestigious awards, including the Paul Zimskind Award from the Society of Urodynamics and Female Urology and Grand Prize in the International Jack Lapides Essay Contest. Dr. Chancellor has received funding from the National Institutes of Health and Department of Definese for over two decades and has trained many of today’s experts in urology.
Friday, May 12
10:00 AM – 12:00 PM
Saturday, May 13
9:30 AM – 11:30 AM
Sunday, May 14
1:10 PM – 2:00 PM