Back to resultsA Long-term Evaluation of a Novel Intravaginal Device
Primary Purpose
Pelvic Floor Disorders, Sexual Dysfunction, Stress Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vSculpt
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders
Eligibility Criteria
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
Sites / Locations
- Egrari Non Invasive Center
- Seattle Obstetrics and Gynecology Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vSculpt, model #VS1100
Arm Description
A novel intravaginal device for females
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03073824
Brief Title
A Long-term Evaluation of a Novel Intravaginal Device
Official Title
An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
November 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joylux, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Sexual Dysfunction, Stress Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vSculpt, model #VS1100
Arm Type
Experimental
Arm Description
A novel intravaginal device for females
Intervention Type
Device
Intervention Name(s)
vSculpt
Intervention Description
Pelvic Floor Toning and Vaginal Rejuvenation Device
Primary Outcome Measure Information:
Title
Improvement in Patient Quality of Life as Measured by Female Sexual Response Index
Description
Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.
Time Frame
365 days
Title
Improvement in patient quality of life as measured by the Female Sexual Distress
Description
Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.
Time Frame
365 days
Title
Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6)
Description
Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.
Time Frame
365 days
Title
Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Description
Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.
Time Frame
365 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah De La Torre, MD
Organizational Affiliation
Seattle OB/GYN Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Egrari Non Invasive Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Seattle Obstetrics and Gynecology Group
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Long-term Evaluation of a Novel Intravaginal Device
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