1. Will I receive any payment to participate in the study?
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.
2. If I participate, how many times do I have to go back to the doctor’s office and how long is the study?
In total there are up to 11 planned visits during the Female SUI Clinical Research Study, including pre-screening visits. Your participation in the study is expected to last approximately 2 years from the time of the initial visit.
3. May I speak on behalf of another person?
No. The study representative will need to speak to the potential study participant directly to determine if she may be eligible to participate and is willing and able to consider participating in the pre-screening process and in this study.
4. What is being tested?
This clinical research study is evaluating whether an investigational product that uses a woman’s own cells may be safe and effective in treating the condition of Stress Urinary Incontinence.
5. Is there a control/placebo group in this clinical research study?
Study participants will be randomly assigned to study treatment with the investigational product or a placebo by an electronic, automated system. The chances are 2-in-3 that a participant will receive the study product that is being tested. Participants that receive the placebo treatment will have the option to have study treatment with the investigational product using their cells for injection after completion of the 12 month follow-up visit.
6. Will the treatment cause temporary or long-term side effects?
This clinical study is evaluating both the safety and effectiveness of the investigational product. The potential side effects will be discussed in detail with you when you meet with a clinical research team member, prior to your decision to participate in the study.
7. What are the responsibilities of study participants?
Participants must agree to have a muscle biopsy conducted, receive one injection of the study product (or placebo), keep an electronic diary (similar to a smart phone) of liquid consumption and urination episodes as directed, wear a pad occasionally to measure leakage, and return for scheduled follow-up visits at which an interview will take place. Certain lab tests will also be conducted. Participants are free to leave the study at any time.
8. When will I know if I am eligible?
If you meet the initial pre-screening criteria and have given your permission to provide your contact information to the research site in your area, the study site will contact you and will be able to determine your eligibility.
9. How will my medical information be kept confidential?
Any information you provide to study representatives prior to your enrollment in the study (contact information entered at this website or information shared with a study representative during pre-screening, for example) will be collected, recorded and/or stored only with your approval and only for the purposes of assessing your eligibility for the Female SUI Clinical Research Study.
Your information will be kept confidential and will not be disclosed, shared or distributed without your express permission.
Your information will be secured using controlled network barriers (firewalls), data encryption, restricted and logged access and by physical means.
10. Are clinical research studies safe?
Before participating in a clinical research study, a participant must agree to meet with a physician who is an Investigator in the study to learn about the study in detail and then sign an Informed Consent Document, which provides detailed information about the safety of a study and study procedures. For more information on clinical research studies, visit: www.clinicaltrials.gov/ct/info
11. Why might I be excluded from the study?
The study product needs to be evaluated in people whose medical histories are quite similar. This helps the researchers and the Food and Drug Administration (FDA) determine whether the investigational product is safe and effective for the use that is being tested. If your medical and health profile indicates that your medical condition does not fit with this study’s eligibility criteria, you will not be able to participate in the study.
12. Are there any other clinical studies?
To find out about other clinical research studies, please visit www.clinicaltrials.gov
, or www.searchclinicaltrials.org
13. What if I get in the study and I decide I do not want to participate anymore? Can I drop out?
If you decide you do not want to be in this study, you may discontinue participation at any time.