Back to resultsSafety, Efficacy and Usage Compliance of the Silk'n Tightra Device
Primary Purpose
Stress Urinary Incontinence, Sexual Dysfunction, Vulvovaginal Atrophy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tightra vaginal device
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Age: 25-65 (at least 18 women in the range of 40-65 and approxi-mately 10 women in the range of 25 - 40)
- The subject has symptoms of vaginal relaxation syndrome and uri-nary incontinence, and desires vaginal rejuvenation treatment.
- The subject has had at least one vaginal delivery
- The subject is sexually active.
- The subject suffers from bad sexual functioning due to vaginal laxity and/or other vaginal symptoms.
- Negative PAP smear and pelvic exam done within last 2 years.
- 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.
- The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
- The subject is able to read the User Manual.
- Negative results in a urine pregnancy test
Exclusion Criteria:
- Active electrical implant/device in any region of the body - Pacemak-er or internal defibrillator.
- Presence of vulvar lesions or disease (dermatitis, human papilloma-virus, herpes simplex, vulvar dystrophy, etc.).
- Superficial metal, piercing or other implants in the treatment area.
- Vaginal or pelvic surgery or anti-incontinence surgery within the past 12 months.
- Current urinary tract infection, pelvic or pelvic tract infection
- Current cancer condition or pre-malignant moles.
- History of skin and genital areas cancer.
- Severe concurrent conditions, such as cardiac disorders, sensory dis-turbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases, per investigator's discretion.
- Pregnancy, nursing, or planned pregnancy within the next two months.
- Prior labiaplasty
- presence of major psychiatric conditions or related need for medica-tion
- Diffuse pain syndrome or chronic pain requiring daily narcotics
- Chronic use of anti-inflammatory agents (including steroids) and im-munosuppressants.
- Undiagnosed abnormal genital bleeding
- Presence of any condition or use of medication known to interfere with sexual activity
- Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilisation.
- Isotretinoin (Accutane) within last 6 months.
- Uterine prolapse, cystocele or rectocele.
- History of bleeding coagulopathies, or use of anticoagulants except for low-dose aspirin.
Sites / Locations
- ProDERM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment - Tightra
Arm Description
Treatment group with the Tightra device
Outcomes
Primary Outcome Measures
An improvement in stress urinary incontinence
Improvement in SUI according to a validated questionnaire (ICIQ)
An improvement in stress urinary incontinence
Improvement in SUI according to a validated questionnaire (IIQ-7)
Secondary Outcome Measures
improvement in sexual functioning
according to a validated questionnaire (FSFI)
Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
According to a validated questionnaire.
Improvement in general satisfaction from the devcie
According to a satisfaction questionnaire
level of reduction in sexual distress
According to a validated questionnaire (FSDS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03900143
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Home Skinovations Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Sexual Dysfunction, Vulvovaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment - Tightra
Arm Type
Experimental
Arm Description
Treatment group with the Tightra device
Intervention Type
Device
Intervention Name(s)
Tightra vaginal device
Intervention Description
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
Primary Outcome Measure Information:
Title
An improvement in stress urinary incontinence
Description
Improvement in SUI according to a validated questionnaire (ICIQ)
Time Frame
8 weeks
Title
An improvement in stress urinary incontinence
Description
Improvement in SUI according to a validated questionnaire (IIQ-7)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
improvement in sexual functioning
Description
according to a validated questionnaire (FSFI)
Time Frame
8 weeks
Title
Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
Description
According to a validated questionnaire.
Time Frame
8 weeks
Title
Improvement in general satisfaction from the devcie
Description
According to a satisfaction questionnaire
Time Frame
8 weeks
Title
level of reduction in sexual distress
Description
According to a validated questionnaire (FSDS)
Time Frame
8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women should participate in this study
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 25-65 (at least 18 women in the range of 40-65 and approxi-mately 10 women in the range of 25 - 40)
The subject has symptoms of vaginal relaxation syndrome and uri-nary incontinence, and desires vaginal rejuvenation treatment.
The subject has had at least one vaginal delivery
The subject is sexually active.
The subject suffers from bad sexual functioning due to vaginal laxity and/or other vaginal symptoms.
Negative PAP smear and pelvic exam done within last 2 years.
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.
The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
The subject is able to read the User Manual.
Negative results in a urine pregnancy test
Exclusion Criteria:
Active electrical implant/device in any region of the body - Pacemak-er or internal defibrillator.
Presence of vulvar lesions or disease (dermatitis, human papilloma-virus, herpes simplex, vulvar dystrophy, etc.).
Superficial metal, piercing or other implants in the treatment area.
Vaginal or pelvic surgery or anti-incontinence surgery within the past 12 months.
Current urinary tract infection, pelvic or pelvic tract infection
Current cancer condition or pre-malignant moles.
History of skin and genital areas cancer.
Severe concurrent conditions, such as cardiac disorders, sensory dis-turbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases, per investigator's discretion.
Pregnancy, nursing, or planned pregnancy within the next two months.
Prior labiaplasty
presence of major psychiatric conditions or related need for medica-tion
Diffuse pain syndrome or chronic pain requiring daily narcotics
Chronic use of anti-inflammatory agents (including steroids) and im-munosuppressants.
Undiagnosed abnormal genital bleeding
Presence of any condition or use of medication known to interfere with sexual activity
Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilisation.
Isotretinoin (Accutane) within last 6 months.
Uterine prolapse, cystocele or rectocele.
History of bleeding coagulopathies, or use of anticoagulants except for low-dose aspirin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Brandt, PhD
Organizational Affiliation
proDERM research institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProDERM
City
Hamburg
ZIP/Postal Code
22869
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
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