This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.
Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle.
Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study.
Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale).
Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit).
Subjects on Hormone Therapies (HT), systemic or local, or within 6 months of cessation of HT prior to inclusion in the study.
Subjects with bleeding disorders.
Subjects with any sexually transmitted disease.
Subjects on prescribed anticoagulants such as antiplatelets and anticoagulants (Heparin, Warfarin, Clopidogrel, Apixaban, Rivaroxaban).
Parallel
Sham (No Treatment)
DeviceThe Sham device is identified to the Active device with the exception that it has a black connector component, part number 10531-02, to block the vacuum from reaching the vaginal tissue with vacuum pump activation. In this manner, the control procedure has been designed to mimic the active therapy to the extent practicable allowing for subject blinding.
Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Safety will be assessed by monitoring all adverse events, with particular attention to serious adverse events (SAEs) related to the device or procedure.
Percentage of Vaginal Superficial Cells to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Quantified using cytological analysis to determine the percentage of superficial cells. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
Vaginal Moisture Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Measured using the modified Schirmer Test to assess changes in vaginal hydration levels. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
Vaginal pH Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
Measured by inserting a cotton swab vaginally, and applying it to the vaginal pH strip to determine changes in vaginal acidity. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
Vaginal Health Index (VHI) changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.
Evaluated using the Vaginal Health Index, which includes assessments of vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture. Changes will be assessed from baseline, at each visit during the treatment phase and up to the 3-month follow-up. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
Vaginal Maturation Index (VMI) changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.
Assessed using cytological analysis to determine the proportion of parabasal, intermediate, and superficial cells. Changes will be assessed from baseline, at each visit during the treatment phase and up to the 3-month follow-up. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
Vaginal Mucosa Assessment (VMA) changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.
Evaluated through clinical examination of the vaginal mucosa, including assessments of atrophy, dryness, and inflammation. Changes will be assessed from baseline, at each visit during the treatment phase and up to the 3-month follow-up. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
Severity of GSM Symptoms changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.
Assessed using a validated symptom severity scale, an 11-point a Visual Analogue Scale (VAS) to evaluate changes in the severity of GSM symptoms. Scale breakdown as reported by the subject is as follows: 0 = None (symptom is not present); 1 - 3 = Mild; 4 - 6 = Moderate; and 7 - 10 = Severe. Changes will be assessed from baseline, at each visit during the treatment phase and up to the 3-month follow-up.
Long-term Safety Evaluation of the VITA AV Clinical System Treatment.
Safety will be assessed by monitoring all adverse events, with particular attention to serious adverse events (SAEs) related to the device or procedure.
Percentage of Vaginal Superficial Cells to evaluate the Long-term Clinical Efficacy of the VITA AV Clinical System Treatment.
Quantified using cytological analysis to determine the percentage of superficial cells.
Vaginal Moisture Levels to evaluate the Long-term Clinical Efficacy of the VITA AV Clinical System Treatment.
Measured using the modified Schirmer Test to assess changes in vaginal hydration levels.
Vaginal pH Levels to evaluate the the Long-term Clinical Efficacy of the VITA AV Clinical System Treatment.
Measured by inserting a cotton swab vaginally, and applying it to the vaginal pH strip to determine changes in vaginal acidity.
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