evaluation of the safety and efficacy of the nuera tight vrf for the treatment of vaginal and vulvar tissue laxity

Conditions: Vagina Atrophy

Summary: up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.

the treatment will include: a treatment of the vaginal canal using the nuera tight vrf small area handpiece. a treatment of the introitus and vestibule using the nuera tight vrf small area hand piece (optional). this is a single center, prospective, open label, single arm study. following screening visit, eligible subjects will be enrolled into the study. each subject will receive 3 treatments, 4 weeks apart and 2 follow up (fu) visits, at 1, and 3 months following the last treatment.

Eligibility criteria:
inclusion criteria: * women age between 35 to 60 * last vaginal delivery is at least 12 months prior to enrollment * self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the vaginal laxity questionnaire (vlq) * sexual activity≥ once per month, with a same partner * willing to use contraception for the duration of the study * negative urine analysis * negative pregnancy test * patient is not pregnant nor planning to become pregnant throughout the duration of the study * willing to improve vaginal lips / genitals appearance (optional) * normal gynecological exam from the recent year * if taking probiotics and/or any other supplement or suppository as part of daily regimen, willing to maintain same regimen throughout the entire duration of the study * able and willing to comply with the treatment/follow-up schedule and requirements · * willing to sign an informed consent exclusion criteria: * previous pelvic floor reconstructive surgery with mesh. * pelvic organ prolapse (pop) \>ii according to the pelvic organ prolapse quantification system * pregnant or lactating * women in post-menopausal stage for more than five years. * active genital infection or sexually transmitted diseases * subject presenting abnormal pap smear result from the last five years with any of the following findings according to the bethesda system (2001) classification: a.. atypical squamous cells-cannot exclude high grade squamous intraepithelial lesion b. atypical glandular cells (endocervical, endometrial not otherwise specified) c. high grade squamous intraepithelial lesion (hsil)d. carcinoma * patients with implantable devices, such as but not limited to pacemakers, implanted defibrillators, and cochlear ear implant * serious systemic disease or any chronic condition that could interfere with study compliance * has metal implant(s) within the treated area, such as surgical clips, plates and screws, intrauterine device (iud) or artificial joints * history of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen. * history of vaginal tissue disease in the treatment area * taken part in a clinical trial involving an investigational drug or device within 30 days prior to screening and through the study duration * presence of vulvar lesions or any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety * nerve insensitivity to heat anywhere in the treatment area, since ongoing feedback by a patient during a procedure is required * previous treatment with a vaginal energy based device, including laser treatment. * any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety