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CompletedNCT03900143Updated May 7, 2019

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

An interventional study of Tightra vaginal device in Stress Urinary Incontinence, Sexual Dysfunction and Vulvovaginal Atrophy, sponsored by Home Skinovations Ltd.. Completed at 1 site in Germany. Open to female participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Home Skinovations Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
Female
01

Study 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 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.
02

Conditions studied

  • Stress Urinary Incontinence
  • Sexual Dysfunction
  • Vulvovaginal Atrophy
03

In context

Urinary Incontinence, Stress

651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.

This study's enrollment of 28 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Home Skinovations Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 ) 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Treatment - Tightra

    Treatment group with the Tightra device

    Device: Tightra vaginal device

Interventions

  • DeviceTightra vaginal device

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

06

What researchers measure

Primary outcomes

  1. An improvement in stress urinary incontinence

    Improvement in SUI according to a validated questionnaire (ICIQ)

    Time frame: 8 weeks

  2. An improvement in stress urinary incontinence

    Improvement in SUI according to a validated questionnaire (IIQ-7)

    Time frame: 8 weeks

Secondary outcomes

  1. improvement in sexual functioning

    according to a validated questionnaire (FSFI)

    Time frame: 8 weeks

  2. Improvement in vaginal tightening (reduced laxity) and improvement in volvovaginal symptoms

    According to a validated questionnaire.

    Time frame: 8 weeks

  3. Improvement in general satisfaction from the devcie

    According to a satisfaction questionnaire

    Time frame: 8 weeks

  4. level of reduction in sexual distress

    According to a validated questionnaire (FSDS)

    Time frame: 8 weeks

07

Study locations

1 site
  • ProDERM
    Hamburg, 22869, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Mar 2019, 1 month.

Of 41 industry-sponsored interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 46. This study's 1 month is below that.

Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2019
First posted
Apr 2, 2019
StartActual
Jan 28, 2019
Primary completionActual
Mar 25, 2019
CompletionActual
Mar 25, 2019
Last update
May 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03900143
Lead sponsor
Home Skinovations Ltd.
Responsible party
Sponsor
First posted
Apr 2, 2019
Start date
Jan 28, 2019
Primary completion
Mar 25, 2019
Completion
Mar 25, 2019
Last update
May 7, 2019

Study contacts

Marianne Brandt, PhD
principal investigator · proDERM research institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Home Skinovations Ltd.

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