Stress Urinary IncontinenceNCT02214784
Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence
A study testing Active Neurotech Vital and Modified Neurotech Vital Device in people with Stress Urinary Incontinence, run by Atlantic Therapeutics at 3 sites in Germany.
Trial summary
Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens when physical activities such as running, jumping and lifting etc are carried out or when increased pressure to the bladder in everyday life is applied by simply sneezing or coughing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Active Neurotech Vital and Modified Neurotech Vital Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2012to Jan 2015
- 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 years and older
- 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.
- Subjects who have signed informed consent form prior to any study related activity.
- Subjects who have previously failed a 6 week volitional pelvic floor muscle training programme or in the Investigators opinion an equivalent lifestyle and exercise programme.
- Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a >4g urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test). Stress urinary incontinence is defined as complaint of involuntary leakage on effort or exertion, or on sneezing and coughing' (International Continence Society).
- Subjects who have scored at least 18 out of 27 for the Stress 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 ≤ 40 kg/m2
- 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.
- Subjects who have a physical condition that would make them unable to perform the study procedures.
- Subjects who have any respiratory condition including a chronic cough or history of same.
- Subjects with a history of an underlying neurological condition.
- Subjects with a history of low back pain involving the spinal nerve root.
- Subjects who are currently taking medication, or have taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergics or anti-histamines or any anti-anxiety medications.
Show all 21Show fewer
- Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
- Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
- 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 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, pump etc).
- Subjects with a history of heart disease or stroke.
- Subjects with a known cancer.
- Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
- 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.
- Any vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical and medical device industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
St Hedwig Krankenhaus
Berlin
Klinikum Brandenburg,
Brandenburg
St Joesph Hospital,
Frankfurt
About this study
Official title: A Randomised Controlled Double-Blind Clinical Study To Evaluate The Safety And Performance Of Neuromuscular Electrical Stimulation (NMES) With The Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence
Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens when physical activities such as running, jumping and lifting etc are carried out or when increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.
There are various treatment options available - surgical operations, pelvic floor exercises/muscle training and electrical stimulation. This study aims to prove that using the Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and tone them and in doing so improving stress urinary incontinence. We are comparing the Neurotech Vital device with an altered Neurotech Vital device that does not give the same stimulation treatment. There is a 50% chance of you receiving the altered device, if you do, you will be offered the non-altered Neurotech vital device after your first 12 week treatment programme. Both devices are identical in looks, but give different stimulations through the skin contact electrodes.
Read the detailed description
The study involves wearing a device that includes a wired garment around the hip and bottom area for a period of 30 minutes, 5 days out of 7, for 12 weeks. During this treatment, electrical stimulation is passed through skin contact electrodes (large sticky black pads) which causes the pelvic floor to contract and relax, without you having to do anything. This treatment is not painful and is very similar to the workout you would get from relaxing and contracting your pelvic floor muscles yourself, however the device produces a much stronger contraction.
The study is open to females who have failed a 6 week exercise programme and have been diagnosed with Stress Urinary Incontinence. It will take place at hospital uro-gynaecology clinics/continence clinics across the United Kingdom. The study could last up to 16 months.
This study is being carried out to further prove that the Neurotech Vital device is an effective way of treating stress urinary incontinence in female participants.The study will look at the results of a 12 week treatment programme with the Neurotech Vital device compared to the modified Neurotech Vital device. It will compare the following:
- how much urine is lost in a standard 1 minute stress test carried out at the baseline visit (start of the treatment) right through to visit 5 (end of the treatment - 12 weeks).
- How much improvement is shown in the quality of life questionnaire (this is measured by ticking questions which have scores attached to them and adding up the total score for the questionnaire). This questionnaire asks questions on quality of life which is affected by stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Active Neurotech Vital, Modified Neurotech Vital Device
- Keywords
- Stress urinary Incontinence, SUI, Continence
- 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.
Active Neurotech VitalDevice
12 weeks treatment for 30 minutes per day, 5 days out of 7.
Modified Neurotech Vital DeviceDevice
12 weeks treatment for 30 minutes per day for 5 days out of 7.
| Study group | Role | What they receive |
|---|---|---|
| Active Neurotech Vital Device | Active comparator | 50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30minutes over 12 weeks. Receives: Device: Active Neurotech Vital |
| Modified Neurotech Vital Device | Placebo comparator | 50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30 minutes over 12 weeks. Receives: Device: Modified Neurotech Vital Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
All participants taking part in a standardised 1-minute stress test
We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at baseline and then what it measures at 12 weeks after the 12 weeks treatment with the device. Comparing these against one another to look at any improvement.
Measured: 12 weeks
All participants to complete a Quality of life questionnaire (I-QOL)
We will look at the scores which are taken from these questionnaires (depending on which answer is ticked by the participant on the questionnaire) at baseline before treatment with the device commences and then again after 12 weeks of treatment with the device and compare the scores for any improvement.
Measured: 12 weeks
Secondary outcomes (14)
participants taking part in a 1 minute stress test
We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule.
Measured: 4, 8, 12 and 26 weeks
participants taking part in a 1-hour pad weight test
The loss of urine in grams after this test at the above time points will be collected and using the definition of dryness (pad weight of less than 1 gram) they will be looked at to see if at any of the above timepoints the participants are classed as dry i.e. have urine loss of less than 1gram following the stres test.
Measured: Stress test done at 4, 8 and 12 weeks during treatment with the device and at 6 months, for the main and cohort part of study
particpants taking part in the stress test and then having the pad weight to show loss of urine.
We are looking at a significant reduction in the weight of the pad after the stress test has taken place, this improvement is defined as a greater than 50% reduction in pad weight in all particpants who took the test at baseline compared to the weight of the pad at 4, 8 and 12 weeks and at 6months for the main and cohort studies.
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
1-hour pad weight test
reduction in pad weight on the 1-hour pad weight test in relation to the mean intensity of the stimulation delivered during the 12-week treatment programme;
Measured: 4, 8 and 12 weeks and at 6 months, for main and cohort part of the study
quality of life questionnaire
quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL) (except for the 12 week assessment which is one of the primary endpoints);
Measured: 4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study
quality of life questionnaire
quality of life questionnaire assessed using the Kings Health Questionnaire (KHQ)
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
24 hour pad weight test
urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test);
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
24 hour pad weight test
dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test;
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
24hour pad weight test
significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 24-hour pad weight test;
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
3-day diary card
number of incontinence episodes/day recorded using a 3-day voiding diary;
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
3-day voiding diary
number of pads used/day recorded using a 3-day voiding diary;
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
Modified Oxford Score
pelvic floor strength and quality of contraction measured using the Modified Oxford Score;
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
Pelvic floor ultrasound
pelvic floor muscle function measured using sonographic/real time ultrasound imaging/recording with displacement measurement using on screen callipers on the sonogram unit to assess volitional contractions
Measured: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
participants taking part in a 1 minute stress test
We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule.
Measured: We will compare the urine loss against the urine loss after 4weeks treatment with the device and also after 8weeks treatment with the device and 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startDec 2012
- Primary completionJan 2015
- Study completionJan 2015
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Therapeutics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R Tunn, Professor, Principal investigator, St Hedwig Krankenhaus, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214784
- Sponsor's protocol ID
- BMR-11-1002
- Other IDs
- ISRCTN68358784
- Status last verified
- Feb 2018
- First submitted
- 4 Sep 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- 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 Randomised Controlled Double-Blind Clinical Study To Evaluate The Safety And Performance Of Neuromuscular Electrical Stimulation (NMES) With The Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02214784
- Acronym / sponsor ID
- BMR-11-1002
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary Incontinence, SUI, Continence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Atlantic TherapeuticsUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Aug 2014 (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.
Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens when physical activities such as running, jumping and lifting etc are carried out or when increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.
There are various treatment options available - surgical operations, pelvic floor exercises/muscle training and electrical stimulation. This study aims to prove that using the Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and tone them and in doing so improving stress urinary incontinence. We are comparing the Neurotech Vital device with an altered Neurotech Vital device that does not give the same stimulation treatment. There is a 50% chance of you receiving the altered device, if you do, you will be offered the non-altered Neurotech vital device after your first 12 week treatment programme. Both devices are identical in looks, but give different stimulations through the skin contact electrodes.
Detailed description
The study involves wearing a device that includes a wired garment around the hip and bottom area for a period of 30 minutes, 5 days out of 7, for 12 weeks. During this treatment, electrical stimulation is passed through skin contact electrodes (large sticky black pads) which causes the pelvic floor to contract and relax, without you having to do anything. This treatment is not painful and is very similar to the workout you would get from relaxing and contracting your pelvic floor muscles yourself, however the device produces a much stronger contraction.
The study is open to females who have failed a 6 week exercise programme and have been diagnosed with Stress Urinary Incontinence. It will take place at hospital uro-gynaecology clinics/continence clinics across the United Kingdom. The study could last up to 16 months.
This study is being carried out to further prove that the Neurotech Vital device is an effective way of treating stress urinary incontinence in female participants.The study will look at the results of a 12 week treatment programme with the Neurotech Vital device compared to the modified Neurotech Vital device. It will compare the following:
- how much urine is lost in a standard 1 minute stress test carried out at the baseline visit (start of the treatment) right through to visit 5 (end of the treatment - 12 weeks).
- How much improvement is shown in the quality of life questionnaire (this is measured by ticking questions which have scores attached to them and adding up the total score for the questionnaire). This questionnaire asks questions on quality of life which is affected by stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Neurotech Vital Device | Active comparator | Device: Active Neurotech Vital50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30minutes over 12 weeks. |
| Modified Neurotech Vital Device | Placebo comparator | Device: Modified Neurotech Vital Device50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30 minutes over 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who are female and at least 18 years of age.
- Subjects who have signed informed consent form prior to any study related activity.
- Subjects who have previously failed a 6 week volitional pelvic floor muscle training programme or in the Investigators opinion an equivalent lifestyle and exercise programme.
- Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a >4g urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test). Stress urinary incontinence is defined as complaint of involuntary leakage on effort or exertion, or on sneezing and coughing' (International Continence Society).
- Subjects who have scored at least 18 out of 27 for the Stress 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 (21 listed)
- Subjects who have an existing medical condition that would compromise their participation in the study.
- Subjects who have a physical condition that would make them unable to perform the study procedures.
- Subjects who have any respiratory condition including a chronic cough or history of same.
- Subjects with a history of an underlying neurological condition.
- Subjects with a history of low back pain involving the spinal nerve root.
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 |
|---|---|---|
| Active Neurotech Vital12 weeks treatment for 30 minutes per day, 5 days out of 7. | Device | Active Neurotech Vital Device |
| Modified Neurotech Vital Device12 weeks treatment for 30 minutes per day for 5 days out of 7. | Device | Modified Neurotech Vital Device |
Primary outcome
All participants taking part in a standardised 1-minute stress test
Time frame: 12 weeks
We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at baseline and then what it measures at 12 weeks after the 12 weeks treatment with the device. Comparing these against one another to look at any improvement.
All participants to complete a Quality of life questionnaire (I-QOL)
Time frame: 12 weeks
We will look at the scores which are taken from these questionnaires (depending on which answer is ticked by the participant on the questionnaire) at baseline before treatment with the device commences and then again after 12 weeks of treatment with the device and compare the scores for any improvement.
14 secondary outcomes
participants taking part in a 1 minute stress test
Time frame: 4, 8, 12 and 26 weeks
participants taking part in a 1-hour pad weight test
Time frame: Stress test done at 4, 8 and 12 weeks during treatment with the device and at 6 months, for the main and cohort part of study
particpants taking part in the stress test and then having the pad weight to show loss of urine.
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
1-hour pad weight test
Time frame: 4, 8 and 12 weeks and at 6 months, for main and cohort part of the study
quality of life questionnaire
Time frame: 4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study
quality of life questionnaire
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
24 hour pad weight test
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
24 hour pad weight test
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
24hour pad weight test
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
3-day diary card
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
3-day voiding diary
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
Modified Oxford Score
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
Pelvic floor ultrasound
Time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
participants taking part in a 1 minute stress test
Time frame: We will compare the urine loss against the urine loss after 4weeks treatment with the device and also after 8weeks treatment with the device and 12 weeks treatment
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.
R Tunn, Professor principal investigator
St Hedwig Krankenhaus, Berlin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Neurotech Vital and Modified Neurotech Vital Device in people with Stress Urinary Incontinence, run by Atlantic Therapeutics at 3 sites in Germany.
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 8 inclusion and 21 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 3 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
All participants taking part in a standardised 1-minute stress test (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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.