Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
NCT ID: NCT03900143
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2019-01-28
2019-03-25
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment - Tightra
Treatment group with the Tightra device
Tightra vaginal device
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
Interventions
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Tightra vaginal device
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
65 Years
FEMALE
Yes
Sponsors
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Home Skinovations Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Marianne Brandt, PhD
Role: PRINCIPAL_INVESTIGATOR
proDERM research institute
Locations
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ProDERM
Hamburg, , Germany
Countries
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Other Identifiers
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DO114314A
Identifier Type: -
Identifier Source: org_study_id
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