Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety, Efficacy and Usage Compliance of the Silk'n Tightra Home Use Device for Improvement of Sexual Functioning, Vulvovaginal Appearance and Reduction of SUI.

Conditions
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Stress Urinary Incontinence, Sexual Dysfunction, Vulvovaginal Atrophy

Intervention / Treatment
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* Device: Tightra vaginal device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment - Tightra<br>Treatment group with the Tightra device | Device: Tightra vaginal device<br>* Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An improvement in stress urinary incontinence | Improvement in SUI according to a validated questionnaire (ICIQ) | 8 weeks | 
| An improvement in stress urinary incontinence | Improvement in SUI according to a validated questionnaire (IIQ-7) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in sexual functioning | according to a validated questionnaire (FSFI) | 8 weeks | 
| Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms | According to a validated questionnaire. | 8 weeks | 
| Improvement in general satisfaction from the devcie | According to a satisfaction questionnaire | 8 weeks | 
| level of reduction in sexual distress | According to a validated questionnaire (FSDS) | 8 weeks |