A Long-term Evaluation of a Novel Intravaginal Device

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

Detailed Description
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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.

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

Conditions
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Pelvic Floor Disorders, Sexual Dysfunction, Stress Incontinence

Intervention / Treatment
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* Device: vSculpt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vSculpt, model #VS1100<br>A novel intravaginal device for females | Device: vSculpt<br>* Pelvic Floor Toning and Vaginal Rejuvenation Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |