NCT03536819已完成不适用
Radio-frequency Rejuvenation for Pelvic Floor and Vagina
InMode MD Ltd.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年11月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS
研究概览
简要总结
Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.
详细描述
This study will evaluate the effects of radiofrequency on pelvic floor strength and the change in associated symptoms through direct measurement and patient reporting. The patients will undergo two separate evaluation appointments then receive two treatments. One group will receive a sham treatment and the other will receive the treatment. The sham group will be offered treatment at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult females between the ages of 35-75, seeking treatments for pelvic floor relaxation syndrome or atrophic vaginitis, which include but are not limited to: pelvic floor laxity, decreased muscle contraction in the pelvic floor, urinary incontinence, sexual dysfunction.
- •Participants must have an evaluation by the Pelvic Floor Physical Therapists. All participants must have a minimum of 30% below average reading on initial assessment of internal or external pelvic floor contraction in order to be included in the study.
- •Negative PAP smear and pelvic exam done within last 1 year.
- •The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- •The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other treatment methods in the treatment areas such surgeries,CO2 treatment, other radiofrequency treatments and fillers injections for the last 12 months and during the entire study period.
排除标准
- •Internal defibrillator, pacemaker, bladder stimulator or any other implanted electrical device anywhere in the body
- •Permanent metal implant in the treatment area
- •History of pelvic floor radiation
- •Any surgery in the treatment area in the last 3 months
- •Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- •Pregnancy and nursing
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
- •Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- •Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization
- •Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema,vitiligo,herpes and rash.
- •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
- •Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
- •Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- •Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
- •Any other previous treatments in the vaginal or perineal area, such as CO2 laser or RF performed on the same area.
- •Any surgical procedure in the vaginal area within the past 12 months.
- •Recent tan from sun, sunbeds or chemicals or planned excessive sun exposure.
结局指标
主要结局
Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS
时间窗: 3 months
There is no signal normalization, this measurement tool is used to measure change in Pelvic Floor Muscle function. Pelvic floor muscle Contractions amplitude are measured in mV (microvolt) 1. Peak internal Pelvic Floor Contractions (steadily higher scores demonstrate improvement)
Recording of Adverse Events (Safety)
时间窗: 3 months
Observation, assessment and recording of reactions
次要结局
- Evaluate Sexual Function Associated With Pelvic Floor Weakness(3 months)
- Evaluate Urinary Symptoms Associated With Pelvic Floor Weakness(3 months)
- Evaluate Sexual Dysfunction Symptoms Associated With Pelvic Floor Weakness(3 months)
- Evaluate Quality of Life Symptoms Associated With Pelvic Floor Weakness(3 months)
- Evaluate Urinary Incontinence Symptoms(3 months)
- Evaluate Quality of Life With Pelvic Floor Conditions(3 months)
研究者
研究点 (2)
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