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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03900143
Study type Interventional
Source Home Skinovations Ltd.
Contact
Status Completed
Phase N/A
Start date January 28, 2019
Completion date March 25, 2019
View Details
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