NCT03073824

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

February 24, 2017

Last Update Submit

November 29, 2018

Conditions

Pelvic Floor DisordersSexual DysfunctionStress Incontinence

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

vSculpt, model #VS1100

EXPERIMENTAL

A novel intravaginal device for females

Device: vSculpt

Interventions

vSculptDEVICE

Pelvic Floor Toning and Vaginal Rejuvenation Device

vSculpt, model #VS1100

Eligibility Criteria

Age30 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Egrari Non Invasive Center

Bellevue, Washington, 98004, United States

Location

Seattle Obstetrics and Gynecology Group

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Pelvic Floor DisordersSexual Dysfunction, PhysiologicalUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesGenital DiseasesUrinary IncontinenceUrination DisordersUrologic DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah De La Torre, MD

    Seattle OB/GYN Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 8, 2017

Study Start

March 6, 2017

Primary Completion

November 29, 2018

Study Completion

November 29, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Locations

US(2)