A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Safety of a Transdermal Gel that Delivers CO2 in the Treatment of Vulvovaginal Atrophy.

This prospective study aimed to assess the efficacy of a transdermal CO2 gel in promoting regeneration in the vulvovaginal area in postmenopausal women experiencing symptoms as part of genitourinary syndrome of menopause (GSM). Transdermal carboxytherapy refers to the application of CO2 through the skin's superficial layer, which is intended to increase oxygenation (through the Bohr effect) and angiogenesis, thus helping to reduce symptoms of GSM. In this study, 20 women with moderate or severe signs or symptoms of vulvovaginal atrophy were randomized to receive either transdermal CO2 therapy (n=10) or a placebo gel (ultrasound gel, n=10).

The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes.

Light, particularly in the visible to far-infrared spectrum, has been applied to the female genital tract with lasers and other devices for nearly 50 years. These have included procedures on both normal and neoplastic tissues, management of condylomata, endometriosis, and menometrorrhagia, and, more recently, a number of fractional laser devices have been applied for the management of genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI), and to achieve so-called vaginal rejuvenation. Photobiomodulation therapy (PBMT) has been proposed as an alternative for use in managing GSM and SUI.

In response to the FDA warning about the use of photomedicine in gynecology.

To alert patients and health care providers about the use of energy-based devices to perform a vaginal "rejuvenation," cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses.

A Prospective Clinical and Instrumental Study on the Effects of a Transcutaneous Cosmeceutical Gel that is Claimed to Produce CO₂.

Carboxytherapy is the therapeutic use of carbon dioxide (CO2) in its gaseous state. Since 1933, carboxytherapy has referred to either the subcutaneous injection of CO2 or percutaneous application in a warm bath. The present clinical study was performed to determine if there were any changes in the dermis after the application of a transcutaneous gel, which is claimed to produce CO2, and, if so, how these changes compared to those with CO2 injection.

Clinical Prospective Study on the Use of Subcutaneous Carboxytherapy in the Treatment of Diabetic Foot Ulcer.

Diabetic footfoot ulcer (DFU) is a serious complication of diabetes mellitus, and possibly the major morbidity of the diabetic foot. It is the most common foot injury in diabetic patients and can lead to lower-extremity amputation. Management of DFU requires a systematic knowledge of the major risk factors for amputation, frequent routine evaluation, scrupulous preventive maintenance, and correction of peripheral arterial insufficiency.

Transcutaneous Temperature Controlled Radiofrequency (TTCRF) for the Treatment of Menopausal Vaginal/Genitourinary Symptoms.

Objective: The aim of this study was to evaluate the effects of non-ablative, monopolar transcutaneous temperature controlled radiofrequency (TTCRF) technology in the treatment of postmenopausal women suffering from genuine stress urinary incontinence (SUI) related to menopause and to evaluate histological changes vaginally associated with the treatment.

Materials And Methods: Subjective and objective symptoms of SUI were assessed in study subjects before and after TTCRF, (1 treatment every 30 days, for 3 months; n=10) and compared with the effects of a placebo treatment on a control group of demographically similar women (n =10). SUI was subjectively evaluated with subjective Urogenital Distress Inventory (UDI-6) and with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TTCRF treatments and objectively with cough stress test.