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

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

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Pelvic Floor Disorders; Stress Incontinence
• Intervention / Treatment: Device: vSculpt

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States, 98004
      • Egrari Non Invasive Center
    • Seattle, Washington, United States, 98104
      • Seattle Obstetrics and Gynecology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vSculpt, model #VS1100; A novel intravaginal device for females	Device: vSculpt; Pelvic Floor Toning and Vaginal Rejuvenation Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Patient Quality of Life as Measured by Female Sexual Response Index	Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.	365 days
Improvement in patient quality of life as measured by the Female Sexual Distress	Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.	365 days
Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)	Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.	365 days
Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)	Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.	365 days

Collaborators and Investigators

• Sponsor: Joylux, Inc.
• Investigators: Principal Investigator: Sarah De La Torre, MD, Seattle OB/GYN Group

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Urinary Incontinence; Urinary Incontinence, Stress; Pelvic Floor Disorders
• Other Study ID Numbers: JOY 1515-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No