Clinical Outcomes and Safety of an Intravaginal Negative Pressure Medical Device in the Treatment of Genitourinary Syndrome of Menopause (GSM): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
研究概览
简要总结
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.
详细描述
There will be up to 6 in-person visits (screening visit, 4 treatment visits and 2 follow-up visits) for all subjects.
Screening After signing the informed consent form, subjects will be screened to ensure they meet the inclusion and exclusion criteria before initiating treatment.
Screening includes collecting information from the patient history (medical history, demographics and medications) as well as conducting the following clinical assessments:
- Dilator suitability.
- Papanicolaou Test (current within last year or repeated within 2 weeks of initial treatment).
- Sexually transmitted infections screening test (gonorrhea, chlamydia, bacterial vaginosis, trichomonas and yeast)
- Pregnancy Test
- Vaginal Health Index (VHI) Score.
- Vaginal pH.
- Clinical examination to confirm that the vaginal canal is free of any lesions other than symptoms of GSM.
- Self-assessment of symptoms related to GSM and confirmation of moderate to severe dyspareunia.
All screening information necessary to evaluate whether the subject meets the inclusion/exclusion criteria should be available and reviewed prior to treatment. Subjects who do not meet the eligibility criteria upon screening will be considered screening failures. Screening failures will not be followed further except in case of adverse events occurring at the screening visit. In this case, subjects will be monitored until the adverse event(s) are resolved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomization with take place after successful screening of the subjects and prior to the first treatment.
Also, 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.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 who anticipate engaging or attempting to engage in sexual activity (with vaginal penetration) at least twice a month during the trial.
- •Vaginal Health Index (VHI) score of less than or equal to
- •Vaginal pH >5.
- •The subject is anatomically suitable to the intravaginal tip as determined by the Investigator.
- •Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results.
- •Vaginal canal free of any lesions other than symptoms of GSM as determined by the Investigator.
- •Negative screening for chlamydia, gonorrhea, bacterial vaginosis, trichomonas and yeast.
- •Willingness and ability to give voluntary written informed consent to participate in the study and comply with protocol requirements.
- •Willingness to refrain from sexual intercourse for at least 48 hours before all visits and for at least 48 hours after all treatments.
- •Willingness to stop using current vaginal lubricant, moisturizers or similar and only use the lubricant provided by the clinic.
- •Willingness to stop using the clinic assigned lubricant for at least 48 hours before all scheduled visits post screening.
- •Willingness to refrain from any pelvic floor therapy for the duration of the trial.
- •Willingness to refrain from enrolling in another clinical trial for the duration of this study.
排除标准
- •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).
- •Any active genital infections.
- •Abnormal Papanicolaou test within the past year.
- •Positive pregnancy test or planned pregnancy during the study period.
- •Complete procidentia or prolapse that in investigator opinion would be unsuitable for probe placement.
- •Subjects with urogenital sinus (this is when urethral opening is combined with the vagina opening), otherwise the urethral opening will be traumatized potentially resulting in a urinary tract infection (UTI).
- •Subjects with a compromised immune system.
- •Subjects who have undergone pelvic irradiation treatment.
- •Subjects who have undergone off-label procedures such as "vaginal rejuvenation" (e.g., laser or thermoablative techniques).
- •Pelvic surgery within 6 months prior to the start of the study.
- •Undiagnosed vaginal bleeding.
- •Subjects with bleeding during screening examination due to friable vaginal mucosa and/or very thin epithelial layer, such that investigator determines the VITA AV treatment would be contraindicated.
- •Subjects receiving chemotherapy or radiotherapy or subjects with any diagnosed gynecological cancers.
- •History of breast cancer who have had chemotherapy within the last 5 years or are on aromatase inhibitors.
- •Any general health or anatomical conditions, mental health or social situation which, in the opinion of the investigator, could represent an increased risk for the subject, or the ability of the subject to complete study requirements.
- •Currently participating or considering participation in any other research of an investigational drug or device. Does not include observational studies.
- •Subjects that have previously received this treatment as part of a clinical trial.
结局指标
主要结局
Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- 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.(Baseline to 3-months post the last treatment.)
- 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.(Baseline to 3-months post the last treatment.)
- 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.(Baseline to 3-months post the last treatment.)
- 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.(Baseline to 3-months post the last treatment.)
- Durability of Benefit 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.(Baseline to 3-months post the last treatment.)
- Female Sexual Function Index (FSFI) 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.(Baseline to 3-months post the last treatment.)