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 Details — Status: Completed

Administrative data

• NCT number: NCT03900143
• Other study ID #: DO114314A
• Status: Completed
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: March 25, 2019

Study information

• Verified date: March 2019
• Source: Home Skinovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Enuresis
• Sexual Dysfunction
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Vulvovaginal Atrophy

Intervention

Device:
• Tightra vaginal device
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.

Locations

Country	Name	City	State
Germany	ProDERM	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Home Skinovations Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An improvement in stress urinary incontinence	Improvement in SUI according to a validated questionnaire (ICIQ)	8 weeks
Primary	An improvement in stress urinary incontinence	Improvement in SUI according to a validated questionnaire (IIQ-7)	8 weeks
Secondary	improvement in sexual functioning	according to a validated questionnaire (FSFI)	8 weeks
Secondary	Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms	According to a validated questionnaire.	8 weeks
Secondary	Improvement in general satisfaction from the devcie	According to a satisfaction questionnaire	8 weeks
Secondary	level of reduction in sexual distress	According to a validated questionnaire (FSDS)	8 weeks