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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900143
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Home Skinovations Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Sexual Dysfunction Vulvovaginal Atrophy Device: Tightra vaginal device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 28, 2019
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 25, 2019

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. An improvement in stress urinary incontinence [ Time Frame: 8 weeks ]
    Improvement in SUI according to a validated questionnaire (ICIQ)

  2. An improvement in stress urinary incontinence [ Time Frame: 8 weeks ]
    Improvement in SUI according to a validated questionnaire (IIQ-7)


Secondary Outcome Measures :
  1. improvement in sexual functioning [ Time Frame: 8 weeks ]
    according to a validated questionnaire (FSFI)

  2. Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms [ Time Frame: 8 weeks ]
    According to a validated questionnaire.

  3. Improvement in general satisfaction from the devcie [ Time Frame: 8 weeks ]
    According to a satisfaction questionnaire

  4. level of reduction in sexual distress [ Time Frame: 8 weeks ]
    According to a validated questionnaire (FSDS)


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only women should participate in this study
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900143


Locations
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Germany
ProDERM
Hamburg, Germany, 22869
Sponsors and Collaborators
Home Skinovations Ltd.
Investigators
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Principal Investigator: Marianne Brandt, PhD proDERM research institute
More Information
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Responsible Party: Home Skinovations Ltd.
ClinicalTrials.gov Identifier: NCT03900143    
Other Study ID Numbers: DO114314A
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations