About the LIBERATE International Study
The anatomical changes that occur to the pelvic floor and vaginal tissues after childbirth, intense exercise or over time can have a lasting impact on a woman’s quality of life. She may lose confidence in performing certain activities due to a fear of leaking. This fear may decrease her quality of life by limiting activities in which she feels comfortable participating.
The Viveve Treatment, SUI protocol, is a single-session, 50-minute treatment performed by a study doctor in an outpatient setting. During the treatment procedure, the tissue inside your vagina will be treated using radiofrequency (RF) energy to heat the vaginal tissue, while using a coolant to protect the surface tissue. It stimulates your body to produce and strengthen collagen, which helps to stabilize the pelvic floor structure, such as the urethra , whose weakening or dysfunction may contribute to a woman’s leaking episodes.
Although this research study is evaluating the Viveve Treatment, SUI protocol, there is a 1 in 3 chance that you may receive a placebo treatment instead of the active Viveve treatment procedure. The placebo treatment procedure resembles the active treatment procedure in every way but does not provide enough energy to elicit a change in the tissue. This study is randomized and blinded, meaning assignment to a treatment is random and neither you nor the study doctor will know which treatment you receive.
This research study will be conducted at a hospital, research center, or a designated study office. After you pre-qualify, the study staff will discuss additional details such as study duration, location, number of visits involved, and help answer any questions you may have. As a study participant, all study procedures and tests will be completed at no cost to you.
You may qualify to participate if you:
• Are a premenopausal woman 18 years of age or older.
• Experience stress urinary incontinence, noticing at least 1 leaking episode per day.
• Are not pregnant or actively trying to get pregnant
• Do not have any implanted electrical devices in your body
Deciding to participate in a clinical research study is a complex and personal decision. If you are unsure and want to learn more about the value of participating in clinical research studies, you can visit our About Clinical Research section to learn more.
If you join this study, you will need to be willing and able to visit your doctor more often than would be necessary if you were not in the study. You will be asked to complete 5 scheduled study visits during the approximately 6 months that you will participate in the study.
Approximately 99 women participants are expected to join the LIBERATE International Study at up to 8 study centers in Canada.
Qualified participants will receive:
• Viveve Treatment, SUI protocol or placebo treatment at no cost
• Compensation for time and travel
• Study related care from a board-certified physician at no cost
Take the Study Pre-Screener to find out whether you may be eligible to take part in the LIBERATE International study. Other study requirements will be assessed by the study staff.
Compensation for time and travel may be available to you
You don’t need to have medical insurance to take part
F.A.Q.’s -The LIBERATE International Study
What is the purpose of this study?
The purpose of this study is to assess the safety and effectiveness of the Viveve Treatment, SUI protocol, for women who are experiencing bladder leakage when conducting their everyday activities. Viveve, the study Sponsor, is conducting this study to submit its results to Health Canada.
What is stress urinary incontinence (SUI) and how will I know whether I am eligible for the LIBERATE International study?
- Women experience stress urinary incontinence (SUI) for a variety of reasons. The anatomical changes that occur in the pelvic and vaginal tissues during childbirth, after intense exercise or with age may cause many women to experience a may cause urine leakage. SUI is a medical condition that is characterized with problems in the female’s bladder response. A woman may experience several leakage episodes a day triggered by coughing or sneezing or other everyday activities. SUI is the most common kind of incontinence in women and is caused by a weakening of of the pelvic floor or urinary structures.
- If you meet the basic criteria for the LIBERATE International study, you will select a center nearest your location. The staff at the study clinic will contact you and confidentially discuss some of the study details in more depth. The staff at the study clinic may ask you some medical questions about your general health history and other criteria to see if you meet the criteria to participate in this study.
Who is the sponsor of this study?
Viveve, Inc, a women’s health and wellness company, is the Sponsor of this study. To learn more about the Sponsor, visit Viveve.com
What is the investigational device treatment that is being tested?
- The Viveve Treatment, SUI protocol is a single-session, 50-minute procedure completed by a doctor. While the Viveve Treatment is currently cleared and available in many countries for the improvement of female vaginal health, the LIBERATE International study is evaluating the treatment for SUI and clearance for this indication in Canada
- During the procedure, the tissue inside your vagina will be treated using radiofrequency (RF) energy, while incorporating a coolant to protect the surface tissue. It stimulates your body to produce and strengthen collagen, which helps to stabilize the structures involved with urine release bladder response, such as the urethra, bladder neck and associated structures. The Viveve Treatment, SUI protocol does not require any other medicine or treatment prior to the procedure.
What is the placebo or sham treatment and is there a chance I will receive the placebo treatment?
The placebo treatment (sometimes referred to as “sham”) resembles the Viveve Treatment, but will not emit enough RF energy to elicit a response in the vaginal tissue. A placebo is used in clinical research studies to determine if the active treatment being evaluated is safer and more effective than no treatment at all. There is a 1/3 chance you will receive the placebo treatment or active treatment. This study is randomized and blinded, meaning assignment to a treatment is random and neither you nor the study doctor will know which treatment you receive.
Do I have to pay or need insurance to participate in the LIBERATE International study?
Medical insurance is not required or necessary for participation in the LIBERATE International study. There is no charge for taking part in this research study. All study related exams, visits and procedures related to the study will be provided at no cost to you.
Do I need to ask my regular doctor before I can participate in this clinical research study?
No. While you do not need to ask for permission, it is recommended you discuss with your regular doctor that you are thinking of participating in this study if you want their advice. Your doctor may wish to contact the study staff (with your permission) to request additional information.
Will I have to switch doctors?
No. This clinical research study will provide short-term study-related care only. Clinical studies do not provide extended or comprehensive primary health care. Your regular doctor may wish to work with the study team to best determine which treatments or medications are most appropriate for your care.
Where are the study clinics/centers?
The study clinics are located at 8 centers across Canada.
Is research right for me?
About Clinical Research
What are clinical trials or research studies?
Clinical Trials, also known as research studies, are studies in which people volunteer to test a new medical treatment or device. These studies start small, usually involving a small number of patients. As the data shows support for positive trends, the studies grow larger including more volunteers. It is with these volunteers that advancement in the diagnosis, treatment and curing of diseases is achieved!
Who can participate?
All studies have specific criteria that must be met prior to enrollment in studies. The specific criteria that must be met are called ‘inclusion criteria.’ Protocols also have what is referred to as ‘exclusion criteria’ which, if met by the participant, excludes them from the study. Eligibility for inclusion in a study can be dependent on a variety of factors, including age, gender, medical history, current treatments, etc. Some studies may rely on participants having a certain illness or condition to study the effects of a treatment, while other studies may require healthy volunteers. All criteria are discussed at length and in detail at your first study visit.
Why should I participate?
Participating in clinical trials allows for specialized medical care with access to new therapies and treatments, at no cost to you. Insurance is not required, and you may be compensated for time and travel. In addition, participating allows for the chance to aid in the development and advancement of medical treatments.
Who Sponsors clinical trials?
Clinical Trials are sponsored by a wide variety of organizations, including but not limited to the government, private pharmaceutical companies, independent research organizations, academic universities and volunteer groups. Trials may also be sponsored by physicians and medical personnel. The LIBERATE International Study is sponsored by Viveve, a women’s health and wellness company.
Where do clinical trials take place?
Trials may take place in a variety of locations, including your doctor’s office, universities, hospitals and community clinics. The location depends on the study.
What is informed consent?
Informed Consent is the process by which a study participant (you) willfully volunteers to participate in the study after reviewing the Informed Consent Form (ICF). Prior to study participation, all volunteers are provided with the ICF for reading and understanding. The ICF details all study information, including purpose, duration, proposed treatment, visits schedules and procedures, and potential risks and benefits. After review, time is spent with the study staff or study doctor to discuss the trial and if it’s right for you. You will be provided ample time to review the consent, ask questions and decide on your own if you want to participate in the study. If you do, the consent form is signed by you and the study staff. A signed copy should be provided to you for your records.
What are the types of clinical trials?
Interventional studies focus on providing participants with certain interventions. These interventions may be new medications or devices, but they may also include changes to diet or exercise. Sometimes, they may even compare treatments or devices
In Observational studies, the focus is on the health outcome of groups of participants according to a research plan or protocol. Participants may receive interventions (including a new medication or treatment), but participants are not specifically assigned an intervention (as in Interventional Studies).
Can I leave a clinical trial after it’s started?
You are free to withdraw from a study at any point in the study. It is important that you let the study team know the reason for withdrawal, and if possible, an early termination visit should be scheduled to ensure safe exit from the study.
Will I be paid for my time and travel?
There are many factors that should affect your decision to participate in a trial. Below are some questions you should take into consideration before deciding to participate:
▪ What is the purpose of the study?
▪ How long will I be in the study?
▪ Who else is in the study?
▪ How do the risks, side effects and benefits compare with my current treatment or approved therapy?
▪ Who will know which intervention I receive in the study? Will I know?
▪ Are hospital visits required?
▪ Who will oversee my care?
▪ Will my study data be provided to me?
▪ Will I be reimbursed for time and travel?
▪ Is there a chance I may receive a placebo/sham (substance with no therapeutic effect)?
▪ What type of long term follow up care is provided?
▪ If success is found with the study treatment, will I have access to it after study completion?