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

NCT03900143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-05-07

No results posted yet for this 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.

Conditions

  • Stress Urinary Incontinence
  • Sexual Dysfunction
  • Vulvovaginal Atrophy

Interventions

DEVICE

Tightra vaginal device

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

Sponsors & Collaborators

  • Home Skinovations Ltd.

    lead INDUSTRY

Principal Investigators

  • Marianne Brandt, PhD · proDERM research institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2019-03-25
Completion
2019-03-25

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900143 on ClinicalTrials.gov