A Long-term Evaluation of a Novel Intravaginal Device

Not Applicable

Completed

• Conditions: Stress Incontinence; Sexual Dysfunction; Pelvic Floor Disorders
• Interventions: Device: vSculpt

• Registration Number: NCT03073824
• Lead Sponsor: Joylux, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-02
• Study Start: 2017-03-06
• Study First Posted: 2017-03-08
• Status Verified: 2018-11
• Primary Completion: 2018-11-29
• Study Completion: 2018-11-29
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vSculpt, model #VS1100	vSculpt	A novel intravaginal device for females

Primary Outcome Measures

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

Trial Locations

Locations (2)

Seattle Obstetrics and Gynecology Group; 🇺🇸 Seattle, Washington, United States

Egrari Non Invasive Center; 🇺🇸 Bellevue, Washington, United States