A Long-term Evaluation of a Novel Intravaginal Device

Joylux, Inc.65 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Floor Disorders Sexual Dysfunction Stress Incontinence

Interventions

vSculptDEVICE

Pelvic Floor Toning and Vaginal Rejuvenation Device

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Egrari Non Invasive Center

Bellevue, Washington, United States

Seattle Obstetrics and Gynecology Group

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 365 days

Data from ClinicalTrials.gov

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