Safety, Efficacy and Usage Compliance of the Silk'n Tightra Home Use Device for Improvement of Sexual Functioning, Vulvovaginal Appearance and Reduction of SUI.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- An improvement in stress urinary incontinence
研究概览
简要总结
This is an open label, prospective study aimed to evaluate safety and efficacy of the Silk'n Tightra device for improvement of sexual functioning, vulvovaginal appearance and reduction of SUI.
详细描述
This is an open label, prospective study aimed to evaluate safety and efficacy of the Silk'n Tightra device.
The study includes 12 treatment sessions 3 times a week, over a period of 4 weeks. Each subject will serve as her own control, while comparing results before and after treatment. Treatment will be performed on the internal volva for 20 min according to the device instructions, .
Subjects that are interested in improving their labial appearance, and are willing to perform the external treatment twice a week in addition to the internal treatments, will be offered to conduct both treatments. The study will include one follow-up visit conducted one month following treatment end. During the second month of the study subjects will perform mainte-nance treatments and will gradually reduce the frequency of the treat-ments as follows:
- Week 5: 2 treatments
- Weeks 6-8: 1 treatment per week.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 25-65 (at least 18 women in the range of 40-65 and approxi-mately 10 women in the range of 25 - 40)
- •The subject has symptoms of vaginal relaxation syndrome and uri-nary incontinence, and desires vaginal rejuvenation treatment.
- •The subject has had at least one vaginal delivery
- •The subject is sexually active.
- •The subject suffers from bad sexual functioning due to vaginal laxity and/or other vaginal symptoms.
- •Negative PAP smear and pelvic exam done within last 2 years.
- •The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side ef-fects, and sign the Informed Consent Form.
- •The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
- •The subject is able to read the User Manual.
- •Negative results in a urine pregnancy test
排除标准
- •Active electrical implant/device in any region of the body - Pacemak-er or internal defibrillator.
- •Presence of vulvar lesions or disease (dermatitis, human papilloma-virus, herpes simplex, vulvar dystrophy, etc.).
- •Superficial metal, piercing or other implants in the treatment area.
- •Vaginal or pelvic surgery or anti-incontinence surgery within the past 12 months.
- •Current urinary tract infection, pelvic or pelvic tract infection
- •Current cancer condition or pre-malignant moles.
- •History of skin and genital areas cancer.
- •Severe concurrent conditions, such as cardiac disorders, sensory dis-turbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases, per investigator's discretion.
- •Pregnancy, nursing, or planned pregnancy within the next two months.
- •Prior labiaplasty
- •presence of major psychiatric conditions or related need for medica-tion
- •Diffuse pain syndrome or chronic pain requiring daily narcotics
- •Chronic use of anti-inflammatory agents (including steroids) and im-munosuppressants.
- •Undiagnosed abnormal genital bleeding
- •Presence of any condition or use of medication known to interfere with sexual activity
- •Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilisation.
- •Isotretinoin (Accutane) within last 6 months.
- •Uterine prolapse, cystocele or rectocele.
- •History of bleeding coagulopathies, or use of anticoagulants except for low-dose aspirin.
研究组 & 干预措施
Treatment - Tightra
Treatment group with the Tightra device
干预措施: Tightra vaginal device (Device)
结局指标
主要结局
An improvement in stress urinary incontinence
时间窗: 8 weeks
Improvement in SUI according to a validated questionnaire (ICIQ)
次要结局
- improvement in sexual functioning(8 weeks)
- Improvement in general satisfaction from the devcie(8 weeks)
- level of reduction in sexual distress(8 weeks)
- Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms(8 weeks)