A Long-term Evaluation of a Novel Intravaginal Device

Joylux

Status

Completed

Conditions

Pelvic Floor Disorders

Sexual Dysfunction

Stress Incontinence

Treatments

Device: vSculpt

Study type

Interventional

Funder types

Other

Identifiers

NCT03073824

JOY 1515-03

Details and patient eligibility

About

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

Full 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.

Enrollment

65 patients

Sex

Female

Ages

30 to 59 years old

Volunteers

Accepts Healthy Volunteers

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