Stress Urinary IncontinenceNCT02423005
Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US
A study testing Neurotech Vital Compact and itouch Sure Pelvic Floor Exerciser in people with Stress Urinary Incontinence, run by Atlantic Therapeutics at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Neurotech Vital Compact and itouch Sure Pelvic Floor Exerciser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are female and at least 18 years of age, and not more than 65 years of age.
- Subjects who have signed the informed consent form prior to any study related activity.
- Subjects who have previously tried and failed to improve their condition using Kegel exercises.
- 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.
- 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.
- Subjects with a Body Mass Index of ≤ 35 kg/m2.
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- 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).
- Subjects who are willing not to seek any other treatment for stress incontinence during the study period.
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
- Subjects who are able to understand this study and are willing to complete all the study assessments.
Who cannot join
- 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.
- 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.
- Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- Subjects with a history of an underlying neurological condition, e.g. Multiple Sclerosis, Parkinson's disease, epilepsy.
- 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.
- Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
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- 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).
- Subjects who have previously had pelvic floor radiation.
- Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months.
- Subjects with a clinical diagnosis of prolapse greater than Stage 2.
- Subjects who are pregnant or could be pregnant.
- Subjects who are less than 6 months post-partum or who are lactating.
- Subjects who have any conductive intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
- Subjects with pelvic pain or fibromyalgia or paravaginal defect.
- 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).
- Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months.
- Subjects who are currently involved in any injury litigation claims.
- Subjects who have participated in a clinical study in the last 3 months or any previous clinical study with Bio-Medical Research Ltd.
- Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Boston Clinical Trials
Boston, Massachusetts, 02131
Medical University of South Carolina
Charleston, South Carolina, 29425
AccuMed Research Associates
Garden City, New York, 11530
Hartford Hospital
Hartford, Connecticut, 06102
The Jackson Clinic
Jackson, Tennessee, 38305
Altus Research
Lake Worth, Florida, 33461
University of California Irvine Medical Center
Orange, California, 92868
Temple University
Philadelphia, Pennsylvania, 19140
Maricopa Integrated Health Systems
Phoenix, Arizona, 85008
Renaissance Health & Surgical Associates
South Pittsburg, Tennessee, 37380
University of South Florida Medical Center
Tampa, Florida, 33606
Lyndhurst Gynecological Associates
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Neurotech Vital Compact, itouch Sure Pelvic Floor Exerciser
- Keywords
- Stress urinary incontinence, Neurotech Vital Compact, 1h Provacative Pad Test, Neuroelectrical Muscle Stimulation (NEMS)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotech Vital CompactDevice
Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.
itouch Sure Pelvic Floor ExerciserDevice
Also called EmbaGYN
Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.
| Study group | Role | What they receive |
|---|---|---|
| Neurotech Vital Compact | Experimental | 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. Receives: Device: Neurotech Vital Compact |
| itouch Sure Pelvic Floor Exerciser | Active comparator | 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. Receives: Device: itouch Sure Pelvic Floor Exerciser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who have achieved >50% improvement on the provocative pad weight test.
Subjects will complete an in-office 1 hour provocative pad test to determine volume of urine leaked during the test.
Measured: 12 weeks
Secondary outcomes (12)
Between group comparison of mean change in urine leakage in a provocative pad weight test
Comparison of change on 1 hour pad test for Vital Compact vs. itouch Sure
Measured: 12 Weeks
Within group comparison of mean change in urine leakage in the 1 hour pad weight test
Comparison of change in urine leakage for each treatment arm
Measured: 12 weeks
Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score
Comparison of change in I-QOL score between groups
Measured: 12 weeks
Between group comparison of the proportion of subjects achieving dryness
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.
Measured: 12 weeks
Between group comparison of mean change in the number of incontinence episodes per day.
Between group comparison of mean change in the number of incontinence episodes per day using a 7-day voiding diary.
Measured: 12 weeks
Between group mean change in urine leakage in the 24-hour pad weight test
Between group comparison of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight test
Measured: 12 weeks
Within Neurotech Vital Compact group estimate of mean change in urine leakage in the 24-hour pad weight
- Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight
Measured: 12 weeks
Within Neurotech Vital Compact group estimate of mean improvement in Incontinence Quality of Life Questionnaire (I-QOL) score
Within Neurotech Vital Compact group estimate of mean improvement, with respect to baseline, in Incontinence Quality of Life Questionnaire (I-QOL) score
Measured: 12 weeks
Between group comparison of mean change in the number of pads used/day
Between group comparison of mean change, with respect to baseline, in the number of pads used/day recorded using a 7-day voiding diary
Measured: 12 weeks
Within Neurotech Vital Compact group estimate of mean change in the number of pads used/day
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
Measured: 12 weeks
Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)
Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)
Measured: 12 weeks
Comparison of adverse events
Comparison between groups of adverse events reported throughout the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Therapeutics
- Sponsor type
- University, hospital or other
- Collaborators
- Bio-Medical Research, Ltd.
- Responsible party
- Sponsor
- Investigators
- Conor Minogue, PhD, Study director, Bio-Medical Research, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423005
- Sponsor's protocol ID
- BMR-13-1001
- Status last verified
- Feb 2018
- First submitted
- 17 Apr 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02423005
- Acronym / sponsor ID
- BMR-13-1001
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Neurotech Vital Compact, 1h Provacative Pad Test, Neuroelectrical Muscle Stimulation (NEMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Atlantic TherapeuticsUniversity, hospital or other
- Collaborators
- Bio-Medical Research, Ltd.
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurotech Vital Compact | Experimental | Device: Neurotech Vital CompactThe 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. |
| itouch Sure Pelvic Floor Exerciser | Active comparator | Device: itouch Sure Pelvic Floor ExerciserThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who are female and at least 18 years of age, and not more than 65 years of age.
- Subjects who have signed the informed consent form prior to any study related activity.
- Subjects who have previously tried and failed to improve their condition using Kegel exercises.
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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.
- 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.
- Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- Subjects with a history of an underlying neurological condition, e.g. Multiple Sclerosis, Parkinson's disease, epilepsy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurotech Vital CompactNeuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment. | Device | Neurotech Vital Compact |
| itouch Sure Pelvic Floor ExerciserAlso: EmbaGYNVaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles. | Device | itouch Sure Pelvic Floor Exerciser |
Primary outcome
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 secondary outcomes
Between group comparison of mean change in urine leakage in a provocative pad weight test
Time frame: 12 Weeks
Within group comparison of mean change in urine leakage in the 1 hour pad weight test
Time frame: 12 weeks
Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score
Time frame: 12 weeks
Between group comparison of the proportion of subjects achieving dryness
Time frame: 12 weeks
Between group comparison of mean change in the number of incontinence episodes per day.
Time frame: 12 weeks
Between group mean change in urine leakage in the 24-hour pad weight test
Time frame: 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 improvement in Incontinence Quality of Life Questionnaire (I-QOL) score
Time frame: 12 weeks
Between group comparison of mean change in the number of pads used/day
Time frame: 12 weeks
Within Neurotech Vital Compact group estimate of mean change in the number of pads used/day
Time frame: 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
Comparison of adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor Minogue, PhD study director
Bio-Medical Research, Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotech Vital Compact and itouch Sure Pelvic Floor Exerciser in people with Stress Urinary Incontinence, run by Atlantic Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who have achieved >50% improvement on the provocative pad weight test. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.