Clinical trial NCT03900143: Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Sexual Dysfunction
Vulvovaginal Atrophy
Lead sponsor: Home Skinovations Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 28
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 25-65 (at least 18 women in the range of 40-65 and approxi-mately 10 women in the range of 25 - 40)
2. The subject has symptoms of vaginal relaxation syndrome and uri-nary incontinence, and desires vaginal rejuvenation treatment.
3. The subject has had at least one vaginal delivery
4. The subject is sexually active.
5. The subject suffers from bad sexual functioning due to vaginal laxity and/or other vaginal symptoms.
6. Negative PAP smear and pelvic exam done within last 2 years.
7. 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.
8. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
9. The subject is able to read the User Manual.
10. Negative results in a urine pregnancy test

Exclusion Criteria:

1. Active electrical implant/device in any region of the body - Pacemak-er or internal defibrillator.
2. Presence of vulvar lesions or disease (dermatitis, human papilloma-virus, herpes simplex, vulvar dystrophy, etc.).
3. Superficial metal, piercing or other implants in the treatment area.
4. Vaginal or pelvic surgery or anti-incontinence surgery within the past 12 months.
5. Current urinary tract infection, pelvic or pelvic tract infection
6. Current cancer condition or pre-malignant moles.
7. History of skin and genital areas cancer.
8. Severe concurrent conditions, such as cardiac disorders, sensory dis-turbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases, per investigator's discretion.
9. Pregnancy, nursing, or planned pregnancy within the next two months.
10. Prior labiaplasty
11. presence of major psychiatric conditions or related need for medica-tion
12. Diffuse pain syndrome or chronic pain requiring daily narcotics
13. Chronic use of anti-inflammatory agents (including steroids) and im-munosuppressants.
14. Undiagnosed abnormal genital bleeding
15. Presence of any condition or use of medication known to interfere with sexual activity
16. Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilisation.
17. Isotretinoin (Accutane) within last 6 months.
18. Uterine prolapse, cystocele or rectocele.
19. History of bleeding coagulopathies, or use of anticoagulants except for low-dose aspirin.

Primary outcomes:
measure: An improvement in stress urinary incontinence
timeFrame: 8 weeks
measure: An improvement in stress urinary incontinence
timeFrame: 8 weeks
Secondary outcomes:
measure: improvement in sexual functioning
timeFrame: 8 weeks
measure: Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
timeFrame: 8 weeks
measure: Improvement in general satisfaction from the devcie
timeFrame: 8 weeks
measure: level of reduction in sexual distress
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: ProDERM
Study officials:
affiliation: proDERM research institute
name: Marianne Brandt, PhD
role: PRINCIPAL_INVESTIGATOR
References: