Personalized Medicine Clinical Trial Underway for Type of Incontinence Common in Women
WASHINGTON (April 2, 2019) — A novel clinical trial aims to reverse the cause of a common problem among older women — accidental urine leakage — by using a patient’s own muscle cells. The study, now underway in the Washington area, is for women with stress urinary incontinence.
Stress urinary incontinence, or SUI, often occurs when the tissues that support the bladder and/or the muscles that regulate the release of urine weaken, and it can have a negative impact on a woman’s quality of life. The condition is especially common after childbirth. SUI can be triggered by physical activity or stressors such as coughing, sneezing, laughing or heavy lifting.
In the new study, conducted by Georgetown University at MedStar Georgetown University Hospital, researchers will examine the safety and effectiveness of a product (autologous muscle derived cells for urinary sphincter repair, or AMDC-USR) derived from a woman’s own muscle cells that are collected, processed, and then injected into the tissues of the urinary passage.
“Being able to use a woman’s own cells as a treatment for stress urinary incontinence holds promise, but we won’t fully understand if this treatment is safe and effective for these women until this clinical trial is completed,” says the study’s principal investigator, Elizabeth Timbrook Brown, MD, MPH, assistant professor of urology at Georgetown University School of Medicine and a specialist in the medical and surgical management of urinary incontinence at MedStar Georgetown University Hospital.
The clinical study lasts 2 1/2 years, and participation includes approximately eight to 11 office visits and three to five scheduled phone calls. The study will consist of a screening period, which may last up to eight weeks, to determine eligibility.
If eligible, Brown will perform a biopsy to collect muscle tissue from the thigh. Local anesthesia will be used for the office procedure.
“The muscle tissue is then grown in a laboratory until there are enough cells to be injected into the urinary passage as a second office procedure,” Brown explains. “It is believed the cells will become part of the tissue where they have been injected. In theory, we think this may help women have more control over urine storage and urination and may decrease urinary leakage.”
Current conservative treatment options are available for women with SUI and include external collection devices (diapers and pads) and pelvic floor exercises. Some examples of surgical treatments include injection of bulking agents into or around the urethra, a synthetic mesh midurethral sling, or creation of a sling using a woman’s own tissues, as well as other surgical procedures.
Women ages 50 to 75 with SUI are invited to volunteer in this phase II, randomized, double blinded, placebo-controlled study. Participants will be “randomized” into one of two study groups — half will receive AMDC-USR (injections with cells) and the other half will receive a placebo (injections that look and feel exactly the same but will have no cells). Randomization is done by computer. Neither the volunteers nor the researchers will know which group each volunteer is in (double blinded). If the participant receives the placebo injection, she will still have the option of receiving a second injection with her own cells (the AMDC-USR product) after 12 months.
Based on information from similar clinical studies using AMDC therapy, urinary tract infections are very common. Other, less common risks will be explained to each participant.
Up to 320 subjects at 25 study centers across three countries will take part in this study; approximately 15 subjects per year will participate at Georgetown. There are no study-related charges for the participants.
Cook MyoSite, Inc. is the sponsor of this study. MedStar Georgetown University Hospital is being paid by Cook MyoSite, Inc. to conduct this study. Brown reports having no personal financial interests related to the study.
Learn more about this clinical trial on ClinicalTrials.gov. Women who are interested in volunteering for the clinical trial may call Kelsey Morgan, BSN, at 202-444-7513 or email her at firstname.lastname@example.org.
About Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic health and science center with a four-part mission of research, teaching, service and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate) and Twitter (@gumedcenter). Connect with Georgetown University School of Medicine on Facebook (Facebook.com/somgeorgetown), Twitter (@gumedicine) and Instagram (@GeorgetownMedicine).