The VIVEVE II Study
Has COMPLETED Enrollment
And is no longer accepting participants at this time.
The VIVEVE II Study
The VIVEVE II study is being conducted to evaluate the Viveve Treatment as a new investigational treatment for women who are having decreased sexual experiences following childbirth, including problems with arousal, desire, lubrication, satisfaction, orgasm and pain during sex.
The anatomical changes that occur to the pelvis and vaginal tissues during childbirth can have a lasting impact on a woman’s sex life. She may experience changes in her sexual desire/interest, sexual excitement/arousal, or her orgasm response (orgasms maybe be weaker than they used to be or may take longer time to achieve them). She may also report pain during or after sex, changes in her overall sexual pleasure/satisfaction or report less vaginal lubrication).
The Viveve Treatment is a single-session, 30-minute treatment performed by a study doctor in an outpatient setting. During the treatment procedure, the tissue just inside your vagina will be treated using radiofrequency (RF) energy to heat the vaginal tissue, while using a surface coolant to protect the treated tissue. It stimulates your body to produce and strengthen collagen, which helps to stabilize the structures involved with a woman’s sexual function, such as the clitoris and associated structures.
The VIVEVE II Study is testing the safety and effectiveness of the Viveve Treatment for women experiencing decreased sexual satisfaction following vaginal childbirth. This study completed enrollment in Q1 2019.
About Clinical Research
What are clinical trials or research studies?
Who can participate?
Why should I participate?
Who Sponsors clinical trials?
Where do clinical trials take place?
What is informed consent?
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?
Is research right for me?
- 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?