NCT03900143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

May 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

March 25, 2019

Last Update Submit

May 6, 2019

Conditions

Stress Urinary IncontinenceSexual DysfunctionVulvovaginal Atrophy

Outcome Measures

Primary Outcomes (2)

  • An improvement in stress urinary incontinence

    Improvement in SUI according to a validated questionnaire (ICIQ)

    8 weeks

  • An improvement in stress urinary incontinence

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

    8 weeks

Secondary Outcomes (4)

  • improvement in sexual functioning

    8 weeks

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

    8 weeks

  • Improvement in general satisfaction from the devcie

    8 weeks

  • level of reduction in sexual distress

    8 weeks

Study Arms (1)

Treatment - Tightra

EXPERIMENTAL

Treatment group with the Tightra device

Device: Tightra vaginal device

Interventions

Tightra vaginal deviceDEVICE

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

Treatment - Tightra

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly women should participate in this study
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProDERM

Hamburg, 22869, Germany

Location

MeSH Terms

Conditions

Urinary Incontinence, StressSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases

Study Officials

  • Marianne Brandt, PhD

    proDERM research institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 2, 2019

Study Start

January 28, 2019

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

May 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)