Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
This study explores a new way to help women who experience accidental urine leaks (stress urinary incontinence) after having surgery. We are testing a treatment called AMDC-USR, which involves taking some of your own muscle cells, processing them, and then injecting them near your bladder. This is compared to a 'dummy' injection (placebo). Neither you nor your doctor will know which treatment you are getting. The main goal is to see if this cell therapy can reduce how often you experience leaks. If you receive the dummy treatment, you might have the option to receive the cell injection later. This research aims to find better ways to manage this common problem and improve quality of life.
At a glance
What is this study about?
Imagine coughing, laughing, or even sneezing, and a small amount of urine escapes — that's called stress urinary incontinence (SUI). This study focuses on women who still experience SUI even after having surgery for it. We're investigating a new treatment that uses your body's own muscle cells to help strengthen the area around the bladder and reduce these leaks.
The treatment, called AMDC-USR (you might hear it called iltamiocel), involves a small procedure. First, a tiny piece of muscle tissue is taken from your body. These cells are then processed and multiplied in a lab. Later, these specially prepared cells are injected into the tissues supporting your urinary passage.
We want to see how well this cell therapy works compared to a 'dummy' injection, known as a placebo. Half the study participants will get the cell injection, and the other half will get the placebo. This helps us accurately understand if the new treatment is effective. If you receive the placebo, you may have the opportunity to receive the active cell treatment after one year.
Key takeaways
- Tests a new cell therapy for bladder leakage in women after surgery.
- Compares real treatment to a dummy treatment (placebo).
- Uses your own muscle cells to help strengthen the bladder area.
- Specifically for women with urine leaks during physical activity (stress incontinence).
- Eligible participants must have had previous incontinence surgery.
- Participation involves injections and follow-up visits.
Who may be eligible?
This study is looking for women aged 18 or older who have been experiencing moderate to severe stress urinary incontinence, where urine leaks when you cough, laugh, or sneeze, for at least six months. You must have had previous surgery for your incontinence, such as a sling procedure.
There are also some reasons why you might not be able to join. For example, if your main problem is urgent need to go to the toilet rather than leaks from physical activity, or if your incontinence has only started recently (less than six months ago). You also can't take part if you haven't tried more basic treatments first, like bladder exercises. Certain medications or medical conditions might also prevent you from joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult woman (18 or over)?
- Have you had accidental urine leaks when you cough, laugh, or sneeze for at least 6 months?
- Have you previously had surgery to treat your urine leaks?
- Have you tried basic treatments for your leaks, like bladder exercises?
- Is your main problem leaks from physical activity, rather than a strong, sudden urge to go to the toilet?
- Are you generally in good health otherwise and able to attend study appointments?
What does participation involve?
If you join this study, you will first have some screenings to ensure you meet all the requirements. This will include keeping a daily diary for three days to track your leaks. If you qualify, you will be randomly assigned to either receive the cell treatment or a placebo (dummy injection).
Neither you nor your study doctor will know which treatment you are receiving until after the main part of the study is over (12 months). You will have regular follow-up appointments and assessments to see how you are doing and track any changes in your symptoms. If you initially received the placebo, you might have the option to receive the cell treatment after 12 months. The full study duration for each participant is not specified but will involve several visits over time.
Potential risks and benefits
Locations (21)
- Del Sol Research Management, LLCVerified postcodeTucson, United States
- San Diego Clinical TrialsVerified postcodeLa Mesa, United States
- UCLA Women's Health Clinical Research Unit/Department of OBGYNVerified postcodeLos Angeles, United States
- Stanford Hospital and ClinicsVerified postcodeStanford, United States
- American Association of Female Pelvic Medicines Research InstituteVerified postcodeWestlake Village, United States
- MedStar Georgetown Hospital Department of UrologyVerified postcodeWashington D.C., United States
- University of Kansas Health SystemVerified postcodeKansas City, United States
- Bennett Institute of Urogynecology and IncontinenceVerified postcodeGrand Rapids, United States
- University of New Mexico Women's Care ClinicVerified postcodeAlbuquerque, United States
- AccuMed Research AssociatesVerified postcodeGarden City, United States
- Northwell Health/The Arthur Smith Institute for UrologyVerified postcodeLake Success, United States
- Columbia University Irving Medical CenterVerified postcodeNew York, United States
Common questions
What is stress urinary incontinence?
It's when you accidentally leak urine during activities like coughing, sneezing, laughing, or exercising.
What is a placebo?
A placebo is a 'dummy' treatment that looks like the real treatment but contains no active medicine. It helps us see if the new treatment really works.
Will I know if I'm getting the real treatment or the placebo?
No, neither you nor your study doctor will know for the first 12 months. This is a common way to conduct fair studies.
What if I get the placebo?
If you receive the placebo, you may have the opportunity to receive the active cell treatment after 12 months.
Can men participate in this study?
No, this particular study is only for adult women.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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