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

Home Skinovations

Status

Completed

Conditions

Stress Urinary Incontinence

Sexual Dysfunction

Vulvovaginal Atrophy

Treatments

Device: Tightra vaginal device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03900143

DO114314A

Details and patient eligibility

About

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.

Full description

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.

Enrollment

28 patients

Sex

Female

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.