Pelvic Floor Disorders, Sexual Dysfunction, Stress Incontinence
Conditions
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.
Interventions
DEVICEvSculpt
Pelvic Floor Toning and Vaginal Rejuvenation Device
Sponsors
Joylux, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed