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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
ProDERM
Hamburg, Germany
An improvement in stress urinary incontinence
Improvement in SUI according to a validated questionnaire (ICIQ)
Time frame: 8 weeks
An improvement in stress urinary incontinence
Improvement in SUI according to a validated questionnaire (IIQ-7)
Time frame: 8 weeks
improvement in sexual functioning
according to a validated questionnaire (FSFI)
Time frame: 8 weeks
Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
According to a validated questionnaire.
Time frame: 8 weeks
Improvement in general satisfaction from the devcie
According to a satisfaction questionnaire
Time frame: 8 weeks
level of reduction in sexual distress
According to a validated questionnaire (FSDS)
Time frame: 8 weeks
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