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Trial record 41 of 88 for:    Recruiting, Not yet recruiting, Available Studies | "Pelvic Floor"

A Long-term Evaluation of a Novel Intravaginal Device

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ClinicalTrials.gov Identifier: NCT03073824
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Joylux, Inc.

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

Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Sexual Dysfunction Stress Incontinence Device: vSculpt Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vSculpt, model #VS1100
A novel intravaginal device for females
Device: vSculpt
Pelvic Floor Toning and Vaginal Rejuvenation Device




Primary Outcome Measures :
  1. Improvement in Patient Quality of Life as Measured by Female Sexual Response Index [ Time Frame: 365 days ]
    Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores.

  2. Improvement in patient quality of life as measured by the Female Sexual Distress [ Time Frame: 365 days ]
    Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores.

  3. Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6) [ Time Frame: 365 days ]
    Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores.

  4. Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) [ Time Frame: 365 days ]
    Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores.



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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073824


Contacts
Contact: Sophia Sanchez 206-219-6444 clinicalstudy@joyluxinc.com

Locations
United States, Washington
Egrari Non Invasive Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Lindsey Miletta, RN BSN    425-827-8285    su@egrari.com   
Seattle Obstetrics and Gynecology Group Recruiting
Seattle, Washington, United States, 98104
Contact: Sarah De La Torre, MD    206-799-7123    sdltconsult@gmail.com   
Sponsors and Collaborators
Joylux, Inc.
Investigators
Principal Investigator: Sarah De La Torre, MD Seattle OB/GYN Group

Responsible Party: Joylux, Inc.
ClinicalTrials.gov Identifier: NCT03073824     History of Changes
Other Study ID Numbers: JOY 1515-03
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Pelvic Floor Disorders
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pregnancy Complications