A Long-term Evaluation of a Novel Intravaginal Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes

NCT02856490

Sexual Dysfunction Stress Incontinence

COMPLETED

RF Rejuvenation for Pelvic Floor and Vagina

NCT03536819

Symptoms Associated With Pelvic Floor Weakness

COMPLETED NA

Pelvital Stress Urinary Incontinence Training Device: P-SUIT

NCT02954042

Incontinence

COMPLETED NA

Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

NCT03520114

Stress Urinary Incontinence Pelvic Floor Disorders

COMPLETED NA

Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function

NCT00376441

Urinary Incontinence Pelvic Organ Prolapse Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Floor Disorders Sexual Dysfunction Stress Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vSculpt, model #VS1100

A novel intravaginal device for females

Group Type EXPERIMENTAL

vSculpt

Intervention Type DEVICE

Pelvic Floor Toning and Vaginal Rejuvenation Device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vSculpt

Pelvic Floor Toning and Vaginal Rejuvenation Device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes