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The Female Stress Urinary Incontinence Clinical Research Study
Midtown Urology, located in Atlanta, Georgia, is participating in a Clinical Research Study sponsored by Cook Myosite, Inc.
Midtown Urology, located in Atlanta, Georgia, is participating in a Clinical Research Study.
Stress Urinary Incontinence (SUI)
If you experience bladder leakage when you laugh, sneeze, cough, or exercise, you may have stress urinary incontinence. If you experience these symptoms, you are one of millions of women with the same condition, which can range from mild leakage to uncontrollable wetting.
Who is affected by Stress Urinary Incontinence?
SUI affects 1 in 3 women in the US. Unfortunately, less than a third of women with these symptoms speak to their doctor about it because they believe nothing can be done.
The Female SUI Clinical Research Study
This Clinical Research study is being conducted to evaluate the safety and effectiveness of an investigational cellular product in women with Stress Urinary Incontinence.
If you choose and qualify to become a study participant, you will be asked to have a muscle biopsy from your thigh, from which some of your muscle cells will be taken. Your cells will be processed at a laboratory and then injected into your urethral sphincter to determine if the cells will reestablish control over the retention and release of urine.
While all study participants will undergo the biopsy procedure, some study participants will receive an injection without cells during the initial injection procedure (called a placebo) in order to compare the performance of the cell injection. An electronic, automated system will randomly determine if study participants receive the investigational product or placebo. You will have a 2 -in- 3 chance of receiving the cellular product that is being investigated.
Following the initial procedure, you will return for approximately six follow-up visits over the next 2 years. Between these visits you will be asked to maintain a 3-day diary to help monitor SUI episodes, (collected electronically on a device similar to a smartphone). At the follow-up visits you may be asked about your quality of life and have lab tests performed (blood and urine tests, for example).
Study Participants who receive the placebo will be given the option to receive the investigational product after the 12 months follow up visit.
Are you eligible to participate?
As with all clinical research studies, participation in the Female SUI Clinical Research Study require that you meet criteria determined by the study protocol.
Women ages 18 and older who have symptoms of SUI, including leakage related to activities such as lifting, coughing, sneezing, may be eligible to participate in this clinical research study.
These are not the only eligibility criteria for the Female SUI Clinical Research Study, and certain other criteria may exclude you. Only a clinical research team member can determine if you can participate.
Modest reimbursement for time and travel may be offered for your participation in this study. Before you decide to participate, the clinical research team will provide details of any reimbursements that may be available.
Is this you?
· Do you have bladder leakage?
· Does it happen when you laugh, sneeze, cough, or exercise?
· Are you a woman over 18 with these symptoms?
· Have you had these symptoms for more than 6 months?
Then it may be time to find out if you may be eligible to participate in a clinical research study.
If you are interested in participating or learning more about the study, please feel free to contact us at 866-309-6065 or 404-881-
Midtown Urology Research Department