AUA2021 Day 2 eNews - 091121

4 AUA2021 DAILY NEWS • SATURDAY • SEPTEMBER 11, 2021 2:1 to receive cellular injection or placebo and stratified by prior surgeries for stress incontinence episode frequency severity of less than 10 or greater than 10 over a three-day diary. Of the 297 women, 199 received the cellular product, and 98 received placebo. Subjects who were originally randomized to placebo could opt to receive open label intrasphincteric injection of 150 × 106 AMDC-USR at 12 months. At one year follow-up, 97 placebo patients opted for the open-label study; all were followed for two years. The primary endpoint of greater than 50% stress incontinence episode frequency reduction (SIEF) at 12 months was not discriminatory between placebo due to exceptional variability in the placebo effect. “At greater than 75% SIEF reduction, we did see meaningful differences between the cellular arm and the placebo arm, particularly in patients who had prior surgical interventions and those with a higher number of leaks at baseline,” Dr. Kaufman said. The correlation between the change in incontinence episode frequency and quality of life was significant, particularly for patients who had a greater than 75% reduction in their stress incontinence episode frequency. For women with SUI, “a single injection of the adult muscle- derived cells is a safe and durable treatment through 2 years,” Dr. Kaufman said, which is consistent with prior data from randomized, double-blind studies. Helping women with refractory incontinence after surgery What happens to women who’ve had previous slings, mesh or bulking agent injections who still have incontinence? A subset analysis of Dr. Kaufman’s autologous muscle-derived cell therapy for women with incontinence focused on this group of women. “An Evaluation of Women with Persistent or Recurrent Stress Urinary Incontinence (SUI) Following Surgery in a Double-blind, Randomized, Controlled Trial Comparing Safety and Efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) with Placebo (PBO),” a multi-center double blind placebo-controlled study, investigated women with SUI with persistent symptoms despite prior surgery. Patients could have up to five prior surgeries. Over 80% required a mid-urethra sling. “This is the greatest unmet need,” said Michael B. Chancellor, MD, the study’s principal investigator. Dr. Chancellor is director of the neurourology program at Beaumont Hospital in Royal Oak, Michigan. Subjects were randomized 2:1; 50 women received the cell therapy injection, and 25 received placebo. After 12 months, placebo patients could receive AMDC-USR. After 12 months, the primary outcome was a greater than 75% reduction in the SIEF. There was significant improvement with AMDC but not with placebo injection. “Moreover, when going on to open label, the placebo patients who received the cell therapy improved,” Dr. Chancellor said. “For women with prior incontinence surgeries, the use of AMDC-USR treatment was safe and well tolerated with follow up over two years. AMDC-URS has been granted an expedited Regenerative Medicine Advanced Therapy designation by FDA. Phase III trials are ongoing.” Could exercise reduce the risk of urinary incontinence? “The Association of Physical Activity and Urinary Incontinence in Women: Results from a Multi- Year National Survey,” set out to identify the relationships between different types of physical activity, both work and recreational, and different types of urinary incontinence among women. The study relied on cross-sectional data from the National Health and Nutritional Examination Survey from 2008 to 2018 from 30,213 women age 20 and older; 23.16% self-reported urge urinary incontinence. “There’s an inverse relationship between physical activity and all types of incontinence,” said Sanam Ladi-Seyedian, a study investigator and research fellow in the department of urology at the University of Southern California. Update on amended AUA/Society of Urologic Oncology joint guideline for NMIBC Updated guideline offers new diagnostic choices and treatment options. T he guideline on non- muscle invasive bladder cancer (NMIBC) from the AUA and the Society of Urologic Oncology, which was published in 2016, was amended and updated in 2020. The newest version includes new treatment options and proven strategies when Bacillus Calmette-Guérin (BCG) is scarce. “These new guidelines are all about individualizing treatment based on careful, ongoing evaluation of the risk of disease and the therapeutic options, plus knowing the new options as well as clinical trials that are available,” said Sam S. Chang, MD, FACS, MBA, vice-chair of urologic surgery and chief surgical officer at the Vanderbilt Ingram Cancer Center in Nashville. “We will be going over the guidelines with a focus on new diagnostic choices, treatment options for difficult- to-treat cases and approaches to consider when BCG is in short supply.” Dr. Chang is course director for Saturday’s session “Guidelines and Beyond: Case-Based Approach to Non-Muscle Invasive Bladder Cancer.” He is an author on the revised guideline that was led by Dr. James McKiernan, MD, professor of urology and chair of urology at New York-Presbyterian/ Columbia in New York City. Although NMIBC has a favorable overall survival rate of 70% to 85% in high-grade cancers, the risk of progression in high-grade lesions is nearly three times that of low-grade lesions, 17% versus 6%. The ability to predict recurrence and risk of progression based on patient- specific disease characteristics holds great prognostic significance, Dr. Chang noted. One of the advantages of this session’s case-based format is the opportunity to interact and engage with faculty who are eager to share their clinical expertise, he added. Course faculty includes: • James Michael McKiernan, MD, professor of urology and chair of urology at New York- Presbyterian/Columbia in New York City • Christopher Anderson, MD, assistant professor of urology at Columbia University Medical Center in New York City • Chad R. Ritch, MD, MBA, associate professor of urology at the University of Miami, Miller School of Medicine • Kristen R. Scarpato, MD, MPH, associate professor of urology at Vanderbilt University Medical Center in Nashville The 2020 update is based on important new literature that has been published since the original guideline was issued in 2016. Urologists may be less familiar with the 2020 guideline update than expected because of the intense focus on COVID-19 last year. Although clinicians may have been distracted in 2020, NMIBC continues to represent about 80% of the estimated 74,000 new bladder cancers diagnosed each year in the United States. Tobacco smoking is the most significant and most common risk factor for the disease. Even though stopping tobacco use can somewhat reduce the risk of carcinogenesis and NMIBC, former smokers remain at higher risk than individuals who have never smoked. BCG remains a key treatment option for many NMIBC patients, but the global shortages of BCG led the AUA to recommend several alternative management strategies that should supersede guideline recommendations. Among other changes, BCG should not be used for patients with low-risk disease. Also, if BCG is not available, alternatives such as gemcitabine, epirubicin, docetaxel, valrubicin, mitomycin or sequential therapies may be considered with an induction and possible maintenance regimen. “Our emphasis on interaction with audience members and discussion of diagnostic and treatment options and more strategies that can be considered in difficult cases will be some of the most useful elements of the course,” Dr. Chang said. Guidelines and Beyond: Case- Based Approach to Non-Muscle Invasive Bladder Cancer Saturday, Sept. 11 2:00 – 4:00 p.m. PDT Sam S. Chang, MD, FACS, MBA Chad R. Ritch, MD, MBA James Michael McKiernan, MD Kristen R. Scarpato, MD, MPH TREATMENT continued from page 1 At greater than 75% SIEF reduction, we did see meaningful differences between the cellular arm and the placebo arm, particularly in patients who had prior surgical interventions and those with a higher number of leaks at baseline.” Melissa R. Kaufman, MD, PhD, FACS,