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About this Research Study:
Who can participate in this research study?
You may qualify to participate in the CELLEBRATE Study if you:
- Are a woman at least 18 years of age
- Experience urine leakage on effort or exertion, or on sneezing or coughing, at least 2 times a day after surgical treatment
- Have tried pelvic floor muscle training (PFMT) and received a surgical treatment for SUI, which didn’t resolve your symptoms
This study is recruiting women aged 18 and older who have persistent stress urinary incontinence following surgical treatment. There are additional criteria that are included in the questionnaire on this website (https://suiclinicalstudy.com/qualify/) and some that are reviewed by the study team at the research center at the first visit.
How long is this research study?
If you meet the criteria to participate in the CELLEBRATE Study and if you choose to take part, the study could last for up to approximately 2.5 years.
How many visits are there?
Participants will be required to visit the study center up to 8–11 times to meet with the study doctor and staff and have up to 5 phone meetings.
What is the product being tested?
The study will look at how safe an investigational product called 'autologous muscle-derived cells for urinary sphincter repair (AMDC)' is and how well it works. If you prequalify, the study doctor can explain more about AMDC.
Is there a placebo?
Participants will be randomly assigned to a study group to receive either investigational product or placebo. The placebo looks exactly like the investigational product, but will not contain your muscle cells or any other active substance. You will have an equal chance of receiving the investigational product or placebo. Neither you nor the study doctor will know if you are receiving the investigational product or placebo.
If you are assigned to the placebo group, you will have the opportunity to receive the investigational product, if you wish, after your first year in the study.
What about my current medications?
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician. You might have to stop taking your regular medication or therapy during the study, but this will be discussed with you at the study center.
Where are the research centers located?
The research centers are located in multiple states within the United States.
Does participating in this study cost me anything?
There is no cost to you or your insurance provider for participating in the research study.
Do I need health insurance to participate?
No, health insurance is not needed in order to participate.
Why did I disqualify?
Research studies are designed in specific ways to test the investigational product for how safe it is and how well it works. One or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.
About Stress Urinary Incontinence (SUI):
What is stress urinary incontinence?
Stress urinary incontinence is a very common condition in women of all ages where urine leaks when there is a sudden increased pressure on the bladder, such as when laughing, coughing, sneezing, or exercising.
What causes stress urinary incontinence?
Stress urinary incontinence is usually caused when the muscles that control the release of urine are weakened.
What types of prior incontinence surgeries may qualify me for the study?
Examples of previous surgery for stress urinary incontinence could include synthetic midurethral sling, autologous fascial sling, or retropubic urethropexy or suspension.
