Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device

May 6, 2019 updated by: Home Skinovations Ltd.

Safety, Efficacy and Usage Compliance of the Silk'n Tightra Home Use 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 for improvement of sexual functioning, vulvovaginal appearance and reduction of SUI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22869
        • proDERM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment - Tightra
Treatment group with the Tightra device
Device: Tightra vaginal device
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
An improvement in stress urinary incontinence
Time Frame: 8 weeks
Improvement in SUI according to a validated questionnaire (ICIQ)
8 weeks
An improvement in stress urinary incontinence
Time Frame: 8 weeks
Improvement in SUI according to a validated questionnaire (IIQ-7)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in sexual functioning
Time Frame: 8 weeks
according to a validated questionnaire (FSFI)
8 weeks
Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
Time Frame: 8 weeks
According to a validated questionnaire.
8 weeks
Improvement in general satisfaction from the devcie
Time Frame: 8 weeks
According to a satisfaction questionnaire
8 weeks
level of reduction in sexual distress
Time Frame: 8 weeks
According to a validated questionnaire (FSDS)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Home Skinovations Ltd.

Investigators

  • Principal Investigator: Marianne Brandt, PhD, proDERM research institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

March 25, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DO114314A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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