Just like skin, vaginal tissue is made up of collagen fibers. During vaginal childbirth these tissues can overstretch, damaging the collagen and creating a feeling of looseness (laxity), especially around the vaginal opening.
Women who experience laxity may also notice a decreased feeling of sensation and sexual satisfaction during intercourse. These changes can affect a woman’s overall sexual health and quality of life.
Vaginal laxity is extremely common. A Viveve sponsored survey of U.S. OB/GYN physicians revealed that vaginal laxity is the number one physical change that they see in their patients following vaginal delivery. Vaginal laxity was indicated to be more common than weight gain, incontinence, stretch marks and other common side effects of childbirth. In a survey of more than four hundred women in the U.S. who had vaginal deliveries, nearly half reported some level of concern with vaginal laxity.
Kegel exercises are the most commonly known and prescribed treatment for vaginal laxity. However, while Kegels may help improve the strength of the pelvic floor by improving muscle tone, they do not address lax tissue between the muscle and the vaginal surface. Surgical options currently available to women include significant recovery time and post-procedure pain. These options also involve a variety of health risks and can include high out-of-pocket costs. Currently, there are no other non-surgical devices specifically designed for the treatment of vaginal laxity.
In contrast, the safe and non-invasive Viveve Treatment works at the cellular level to rebuild and restore collagen and as a result can increase vaginal tightness and improve sexual satisfaction.
Viveve is a new office-based, non-surgical medical procedure for treating vaginal laxity. The 30-minute procedure does not require any anesthesia or analgesics and is performed by a trained physician in an outpatient setting. The Viveve System uses radiofrequency energy to stimulate the body’s collagen formation processes, which leads to increased vaginal tightness and can improve sexual satisfaction.
The Viveve Treatment is the only clinically proven and effective, non-surgical procedure specifically designed for vaginal introital laxity. There is little to no downtime and the patient can return to normal activities immediately following the procedure.
Two clinical studies have been published in the Journal of Sexual Medicine and the Journal of Women’s Health. Results analyzed from studies done with a total of 54 in the U.S. and Japan Studies showed statistically significant improvement in vaginal tightness, to pre-childbirth levels, at 1, 3, 6, and 12 months following treatment. At 12 months, improved and sustained tightness was shown by 88% of the women. Significant improvement in sexual satisfaction was indicated through 12 month follow-up. These results were achieved after a single, painless, office-based Viveve Procedure.
The Viveve Treatment is performed by a trained physician in their medical office or clinic.
Based on available clinical data, the Viveve Treatment is safe and effective. Government regulatory agencies, in countries where the Viveve System is available for sale, have reviewed the safety profile in detail, prior to granting a medical device license or approval to sell or distribute the product.
Side effects seldom occur and are typically mild, temporary, and resolve shortly after treatment. They can include: slight, white vaginal discharge; redness or swelling; slight abdominal discomfort, focal, transient altered sensation and tingling following treatment.
In rare cases, a Viveve patient could develop an infection requiring antibiotics. Although no permanent complications have been reported to date, there is a remote possibility of damage to the urethra or rectum.
The Viveve Treatment is contraindicated for patients with either an implantable pacemaker or an AICD (Automatic Implantable Cardioverter/Defibrillator) or any other implantable device as they may be adversely affected by radiofrequency (RF) fields or current.