Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US

February 1, 2018 updated by: Atlantic Therapeutics

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, randomised, controlled, single-blind, multi-site clinical study to be conducted in the United States of America (USA) 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.

Subjects included in the clinical study will be evaluated at screening, on enrolment into the study (baseline) and during the 12-week treatment programme at 4 and 12 weeks. A telephone call will be made at 1 week to check on the patient's progress. In addition, subjects will be evaluated at 26 week following their commencement of the treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health Systems
    • California
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • Tampa, Florida, United States, 33606
        • University Of South Florida Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecological Associates
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic
      • South Pittsburg, Tennessee, United States, 37380
        • Renaissance Health & Surgical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects who are female and at least 18 years of age, and not more than 65 years of age.
  2. Subjects who have signed the informed consent form prior to any study related activity.
  3. Subjects who have previously tried and failed to improve their condition using Kegel exercises.
  4. Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a greater than or equal to 3g urine leakage and a less than or equal to 90g urine leakage (>3g and < 90g) following a bladder-filling protocol and then a standardised stress test (provocative pad weight test) at the baseline assessment.
  5. Subjects who score 9 or less (<9) out of 18 for the Urge Incontinence Questions and are confirmed as having predominant stress urinary incontinence on the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
  6. Subjects with a Body Mass Index of ≤ 35 kg/m2.
  7. Subjects of child-bearing potential who are using a highly effective contraceptive method (established use of oral, injected, implanted hormonal method of contraception or barrier method of contraception with spermicide).
  8. Subjects who are willing not to seek any other treatment for stress incontinence during the study period.
  9. Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
  10. Subjects who are able to understand this study and are willing to complete all the study assessments.

Exclusion Criteria:

  1. Subjects who have an existing medical condition that would compromise their participation in the study, e.g. reduced sensory perception in the contact area of the stimulation electrodes; scars or vaginal tissue wounds, lesions or inflamed/infected areas in the contact area of the stimulation electrodes; vaginal bleeding between menstrual periods; uncontrolled diabetes.
  2. Subjects who have a physical condition that would make them unable to perform the study procedures, e.g. pelvic or hip surgery within the past 6 weeks.
  3. Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
  4. Subjects with a history of an underlying neurological condition, e.g. Multiple Sclerosis, Parkinson's disease, epilepsy.
  5. Subjects with any bladder abnormality that would affect the urinary flow through the lower urinary tract including signs or symptoms of an active urinary tract infection, abnormal bladder capacity (e.g., >300 cc), post void residual volume >200 cc, spastic bladder, vesico-ureteral reflux or bladder stones.
  6. Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
  7. Subjects who have previously had any uro-gynaecological related surgery that would affect the pelvic floor muscles or urinary flow through the urethra (excluding hysterectomy).
  8. Subjects who have previously had pelvic floor radiation.
  9. Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months.
  10. Subjects with a clinical diagnosis of prolapse greater than Stage 2.
  11. Subjects who are pregnant or could be pregnant.
  12. Subjects who are less than 6 months post-partum or who are lactating.
  13. Subjects who have any conductive intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
  14. Subjects with pelvic pain or fibromyalgia or paravaginal defect.
  15. Subjects with an active implanted medical device (i.e. pacemaker, insulin pump etc.) or conditions that may be adversely affected by electrical stimulation (e.g. cardiac arrhythmias).
  16. Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months.
  17. Subjects who are currently involved in any injury litigation claims.
  18. Subjects who have participated in a clinical study in the last 3 months or any previous clinical study with Bio-Medical Research Ltd.
  19. Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neurotech Vital Compact
The Neurotech Vital Compact will be used by subjects with Stress Urinary Incontinence 5 days per week for 30 minutes per session for 12 weeks followed by 14 weeks of Kegel exercises.
Device: Neurotech Vital Compact
Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.
Active Comparator: itouch Sure Pelvic Floor Exerciser
The itouch Sure Pelvic Floor Exerciser will be used by subjects with Stress Urinary Incontinence 7 days per week for 20 minutes per session for 12 weeks followed by 14 weeks of Kegel exercises.
Device: itouch Sure Pelvic Floor Exerciser
Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.
Other Names:
  • EmbaGYN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects who have achieved >50% improvement on the provocative pad weight test.
Time Frame: 12 weeks
Subjects will complete an in-office 1 hour provocative pad test to determine volume of urine leaked during the test.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between group comparison of mean change in urine leakage in a provocative pad weight test
Time Frame: 12 Weeks
Comparison of change on 1 hour pad test for Vital Compact vs. itouch Sure
12 Weeks
Within group comparison of mean change in urine leakage in the 1 hour pad weight test
Time Frame: 12 weeks
Comparison of change in urine leakage for each treatment arm
12 weeks
Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score
Time Frame: 12 weeks
Comparison of change in I-QOL score between groups
12 weeks
Between group comparison of the proportion of subjects achieving dryness
Time Frame: 12 weeks
The treatment arms will be compared regarding the proportion of subjects who leak less than 1 g at the 12 week 1 hour pad test.
12 weeks
Between group comparison of mean change in the number of incontinence episodes per day.
Time Frame: 12 weeks
Between group comparison of mean change in the number of incontinence episodes per day using a 7-day voiding diary.
12 weeks
Between group mean change in urine leakage in the 24-hour pad weight test
Time Frame: 12 weeks
Between group comparison of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight test
12 weeks
Within Neurotech Vital Compact group estimate of mean change in urine leakage in the 24-hour pad weight
Time Frame: 12 weeks
• Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight
12 weeks
Within Neurotech Vital Compact group estimate of mean improvement in Incontinence Quality of Life Questionnaire (I-QOL) score
Time Frame: 12 weeks
Within Neurotech Vital Compact group estimate of mean improvement, with respect to baseline, in Incontinence Quality of Life Questionnaire (I-QOL) score
12 weeks
Between group comparison of mean change in the number of pads used/day
Time Frame: 12 weeks
Between group comparison of mean change, with respect to baseline, in the number of pads used/day recorded using a 7-day voiding diary
12 weeks
Within Neurotech Vital Compact group estimate of mean change in the number of pads used/day
Time Frame: 12 weeks
Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, in the number of pads used/day recorded using a 7-day voiding diary
12 weeks
Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)
Time Frame: 12 weeks
Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)
12 weeks
Comparison of adverse events
Time Frame: 6 months
Comparison between groups of adverse events reported throughout the study.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atlantic Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bio-Medical Research, Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Conor Minogue, PhD, Bio-Medical Research, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BMR-13-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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