Do you worry about leaking each time you laugh, cough or sneeze?
If so, you may be one of the many women who experience stress urinary incontinence.
The LIBERATE International study is testing the effectiveness of the Viveve treatment, SUI protocol, in improving stress urinary incontinence (SUI).
About the LIBERATE International Study
The LIBERATE International study is being conducted to evaluate the Viveve Treatment, SUI protocol, as a non-invasive, new investigational treatment for women who leak urine during certain activities including laughing, coughing, sneezing, or other physical activities.
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 doctor’s 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 the study 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
Contact us today to see if you are eligible to participate!