A Long-term Evaluation of a Novel Intravaginal Device

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073824
• Other study ID #: JOY 1515-03
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: November 29, 2018

Study information

• Verified date: November 2018
• Source: Joylux, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Sexual Dysfunction
• Stress Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• vSculpt
Pelvic Floor Toning and Vaginal Rejuvenation Device

Locations

Country	Name	City	State
United States	Egrari Non Invasive Center	Bellevue	Washington
United States	Seattle Obstetrics and Gynecology Group	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Joylux, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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