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Completed Not applicable Interventional

Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US

ClinicalTrials.gov ID: NCT02423005

Public ClinicalTrials.gov record NCT02423005. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 3:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single-blind, Multi-centre, Randomised, Controlled, Non-inferiority, Clinical Study to Assess the Safety and Performance of the Neurotech Vital Compact Device Compared to the Itouch Sure Pelvic Floor Exerciser for the Treatment of Stress Urinary Incontinence in Female Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A prospective, randomised, controlled, single-blind, multi-site clinical study employing Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress urinary incontinence. Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary incontinence will be enrolled in this study. All patients who are considered eligible to participate in the clinical study and give consent will be randomised to complete either a 12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will be completed by the subjects at home with treatment with the device in accordance with the device Instructions for Use.

Study identification

NCT ID
NCT02423005
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Atlantic Therapeutics
Other
Enrollment
180 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2015
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update posted
Feb 4, 2018

2015 – 2017

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Maricopa Integrated Health Systems Phoenix Arizona 85008
University of California Irvine Medical Center Orange California 92868
Hartford Hospital Hartford Connecticut 06102
Altus Research Lake Worth Florida 33461
University of South Florida Medical Center Tampa Florida 33606
Boston Clinical Trials Boston Massachusetts 02131
AccuMed Research Associates Garden City New York 11530
Lyndhurst Gynecological Associates Winston-Salem North Carolina 27103
Temple University Philadelphia Pennsylvania 19140
Medical University of South Carolina Charleston South Carolina 29425
The Jackson Clinic Jackson Tennessee 38305
Renaissance Health & Surgical Associates South Pittsburg Tennessee 37380

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02423005, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 4, 2018 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02423005 live on ClinicalTrials.gov.

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