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Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US

NCT02423005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Neurotech Vital Compact

Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.

DEVICE

itouch Sure Pelvic Floor Exerciser

Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.

Sponsors & Collaborators

  • Bio-Medical Research, Ltd.

    collaborator INDUSTRY

  • Atlantic Therapeutics

    lead OTHER

Principal Investigators

  • Conor Minogue, PhD · Bio-Medical Research, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423005 on ClinicalTrials.gov