Skip to main content
OpenTrials
Completed

NCT Number: NCT03073824

A Long-term Evaluation of a Novel Intravaginal Device

An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Stress Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Egrari Non Invasive Center, Bellevue, Washington, United States

Loading trial locations.

About this study

To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All study participants are required to be biological females (genotype XX) to participate
  • Female participants will be of adult age, over 18
  • Female participants with self-reported concerns with bladder and sexual function
  • Female participants who have reliable and consistent computer and internet access on a daily basis

Exclusion criteria

  • Female participants shall not have an active sexually transmitted disease and/or infection
  • Female participants who are actively undergoing chemotherapy or radiation
  • Female participants who are currently taking any cancer-related or photosensitivity drugs
  • Female participants who are pregnant, who may think they are pregnant, and/or actively trying to get pregnant during the clinical study

Treatment and study plan

vSculpt

Device

Pelvic Floor Toning and Vaginal Rejuvenation Device

Primary outcomes

  1. Improvement in Patient Quality of Life as Measured by Female Sexual Response Index

    Time frame: 365 days

    Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.

  2. Improvement in patient quality of life as measured by the Female Sexual Distress

    Time frame: 365 days

    Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.

  3. Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)

    Time frame: 365 days

    Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.

  4. Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)

    Time frame: 365 days

    Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.

Sponsors and collaborators

Lead sponsor

Joylux, Inc.

Other

Registry information

Official study title

An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Dec 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.