Viveve Medical recently published the results of a clinical study of its Viveve I treatment in the Journal of Sexual Medicine, showing that women who received the treatment reported being more likely to have no vaginal laxity.
The Viveve Treatment of the Vaginal Introitus to Evaluate Efficacy study is one of the first studies to study the safety and efficacy of energy-based procedures in gynecological applications that was randomized, single-blinded and sham-controlled. It was meant to show the efficacy and safety of Viveve treatment as opposed to a sham control procedure for vaginal introital laxity treatment. The study included two groups of women, one that was going to receive the treatment and the other that was going to be the sham group.
The Viveve I treatment uses cryogen-cooled monopolar radiofrequency (CMRF) to deliver gentle volumetric heating while cooling delicate surface tissue, allowing collagen to form. It is designed for women who are suffering from the changes in their bodies after giving birth. The treatment can be done in an outpatient clinic in a 30-minutes.
“Publication of the Viveve I results, we believe, is a benchmark for the use of energy-based treatments for women’s sexual health conditions,” said CEO of Viveve Patricia Scheller in a news release. “Large, randomized, sham-controlled studies have not historically been conducted to demonstrate the safety and efficacy of energy-based procedures in gynecological applications, including vaginal laxity, a significant medical condition affecting millions of women worldwide that may lead to a reduction in sexual function. Viveve is the only company in the energy-based device arena to undertake, successfully complete and have published the results from a female sexual function study of this magnitude.”
The results of the study showed that women who were receiving the treatment were 3 times more likely to have no vaginal laxity at the 6-month mark as opposed to the sham group. Those who received the treatment also reported significant and sustained improvement in sexual function after one treatment. It was also reported that there was sexual function improvement in 93% of subjects in the group that received the treatment.
“The purpose of the study on Geneveve was to assess it as a treatment to address the underlying vaginal tissues of the introitus on the cellular level. It is non-ablative and requires no anesthesia,” said Michael Krychman, M.D., executive director of the Southern California Center for Sexual Health and Survivorship Medicine and the primary author of the publication. “Unlike other energy-based vaginal procedures, the Geneveve CMRF technology is intended to uniformly deliver deep penetrating volumetric heat into the submucosal layer of the vaginal opening while gently cooling and protecting the delicate surface tissue. The result is to generate robust natural activation of cells that will produce new collagen deposition.”
The Viveve treatment is different from other methods, like kegels, because it doesn’t require a routine treatment or commitment to an exercise.
“If it is cleared by the FDA for the treatment of vaginal laxity or sexual function, we believe it will offer a treatment option to women that will not rely on compliance with a routine,” said Krychman. “Kegel exercises are commonly prescribed to women following pregnancy and childbirth, and may strengthen the pelvic floor muscles that support the internal organs (uterus, bladder, and bowels) which if weakened can allow these organs to press or fall onto the vagina. Kegel exercises require a substantial ongoing patient commitment, and many women do not adhere to a strict program of pelvic exercise.”
Viveve medical submitted an Investigational Device Exemption (IDE) to the FDA in September 2016 to be authorized to start the Viveve Treatment of the Vaginal Introitus to Evaluate Efficacy (Viveve II) study. Upon completion of the review from the FDA, Viveve will begin its study in the U.S.
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