Trials / Completed
CompletedNCT03900143
Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
Safety, Efficacy and Usage Compliance of the Silk'n Tightra Home Use Device for Improvement of Sexual Functioning, Vulvovaginal Appearance and Reduction of SUI.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Home Skinovations Ltd. · Industry
- Sex
- Female
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tightra vaginal device | Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence. |
Timeline
- Start date
- 2019-01-28
- Primary completion
- 2019-03-25
- Completion
- 2019-03-25
- First posted
- 2019-04-02
- Last updated
- 2019-05-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03900143. Inclusion in this directory is not an endorsement.