Stress Urinary IncontinenceNCT03900143
Safety, Efficacy and Usage Compliance of the Silk'n Tightra Device
A study testing Tightra vaginal device in people with Stress Urinary Incontinence and Sexual Dysfunction, run by Home Skinovations Ltd. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Sexual Dysfunction, Vulvovaginal Atrophy
- What is being tested?
- Tightra vaginal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2019to 25 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Tightra vaginal device
- Medical subject headings
- Urinary Incontinence, Stress, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tightra vaginal deviceDevice
Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Tightra | Experimental | Treatment group with the Tightra device Receives: Device: Tightra vaginal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
An improvement in stress urinary incontinence
Improvement in SUI according to a validated questionnaire (ICIQ)
Measured: 8 weeks
An improvement in stress urinary incontinence
Improvement in SUI according to a validated questionnaire (IIQ-7)
Measured: 8 weeks
Secondary outcomes (4)
improvement in sexual functioning
according to a validated questionnaire (FSFI)
Measured: 8 weeks
Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
According to a validated questionnaire.
Measured: 8 weeks
Improvement in general satisfaction from the devcie
According to a satisfaction questionnaire
Measured: 8 weeks
level of reduction in sexual distress
According to a validated questionnaire (FSDS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start28 Jan 2019
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Home Skinovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Brandt, PhD, Principal investigator, proDERM research institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900143
- Sponsor's protocol ID
- DO114314A
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03900143
- Acronym / sponsor ID
- DO114314A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Home Skinovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - Tightra | Experimental | Device: Tightra vaginal deviceTreatment group with the Tightra device |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tightra vaginal deviceVaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence. | Device | Treatment - Tightra |
Primary outcome
An improvement in stress urinary incontinence
Time frame: 8 weeks
Improvement in SUI according to a validated questionnaire (ICIQ)
An improvement in stress urinary incontinence
Time frame: 8 weeks
Improvement in SUI according to a validated questionnaire (IIQ-7)
4 secondary outcomes
improvement in sexual functioning
Time frame: 8 weeks
Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms
Time frame: 8 weeks
Improvement in general satisfaction from the devcie
Time frame: 8 weeks
level of reduction in sexual distress
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Brandt, PhD principal investigator
proDERM research institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tightra vaginal device in people with Stress Urinary Incontinence and Sexual Dysfunction, run by Home Skinovations Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An improvement in stress urinary incontinence (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.