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?
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 patients, and/or healthy 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 VIVEVE II 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. 
Is research right for me?
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?