Plain English Summary
Background and study aims
Stress Urinary Incontinence (SUI) is described as an uncontrolled release of urine which happens during physical activities such as running, jumping and lifting or when simply sneezing or coughing. There are various treatment options available: surgical operations, pelvic floor exercises/muscle training (for muscles that are present below the pelvis region) and electrical stimulation. This study aims to prove that using the Neurotech Vital (NTV) device for 12 weeks can stimulate the pelvic floor muscle, making it stronger and in doing so improving SUI in women. We are comparing the NTV with an altered NTV that does not give the same stimulation treatment. There is a 50% chance of you receiving the altered NTV. If you do, you will be offered the non-altered NTV after your first 12-week programme. The devices look identical , but give different stimulations through the skin contact electrodes.
Who can participate?
The study is open to women who have failed a 6-week exercise programme and have been diagnosed with SUI.
What does the study involve?
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 a week 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, but the device produces a much stronger contraction.
What are the possible benefits and risks of participating?
There are no anticipated risks to involvement in this study than would be expected for normal treatment of this condition with other devices which use electrical stimulation. Sensitivity to the skin contact electrodes could be possible but there is no reason to suspect that any reaction would happen or that there would be any long-term health problems.
Where is the study run from?
The study is already running in Germany and further sites will be opened in the UK.
When is study starting and how long is it expected to run for?
The study starts in early 2014 and is expected to go on for one year.
Who is funding the study?
Bio-Medical Research, Ireland.
Who is the main contact?
Mrs Karen Robson
krobson@bmr.ie
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Karen Robson
ORCID ID
Contact details
Bio-Medical Research Ltd
Parkmore Business Park West
Galway
N/A
Ireland
00353 9177 4326
krobson@bmr.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BMR-11-1002
Study information
Scientific title
A Randomised Controlled double-blind clinical Trial to evaluate the safety and performance of Neuromuscular Electrical Stimulation (NMES) with the NeuroTech Vital device for the treatment of stress urinary incontinence (SUI)
Acronym
NTV RCT
Study hypothesis
The purpose of this study is to test whether a 12-week programme of treatment with the Neurotech Vital (NTV) significantly improves the symptoms of stress urinary incontinence (SUI) in female subjects compared to a modified NTV device. This will be assessed by comparing a 1-minute stress test at 1 hour post-bladder filling protocol, a 24 hour pad weight test, quality of life questionnaires and completion of a 3-day voiding diary and incontinence episode over a 24 hour period. The primary objective is to show the reduction from baseline to 12 weeks in pad weight following a standardised 1-minute stress test at 1 hour post-bladder filling protocol and the improvement from baseline to 12 weeks in quality of life measured by the Incontinence Quality of Life Questionnaire (IQOL)
Ethics approval
We do not have UK ethics approval yet. Submission is to be finalised by the beginning of September. At that point a MREC meeting will be applied for which is suitable for a medical device study approval.
Study design
Prospective randomised controlled double-blind multi-centre clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Uro-gynaecology (Stress Urinary Incontinence)
Intervention
Screening, visit 1 : patients are assessed for eligibility
Baseline visit 2 : week 0 - patients are randomized, they either get the Neurotech Vital (active group) or the modified Neurotech Vital (control group)12 weeks treatment with either device
Follow up visit 3 : 4 weeks later
Follow up visit 4 : 8 weeks
Follow up visit 5: 12 weeks - end of treatment. Patients are asked if they are happy with the treatment they received if no, they are un-blinded and if they were allocated the modified device they can have a further 12 weeks treatment. If they had the active device they continue on to kegels and visit 6 (14 weeks later) and telephone call 7 and telephone call 8. Patients who have a further 12 weeks treatment will go back to visit 0 baseline and continue right through to the telephone call 8.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measures
1. Reduction from baseline to 12 weeks in urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test)
2. Improvement from baseline to 12 weeks in quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL)
Secondary outcome measures
The following secondary endpoints will be analysed for the main and the cohort study at 4, 8 and 12 weeks and at 6 months compared to baseline.
1. Urine leakage following a 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test) (except for the 12 week assessment which is one of the primary endpoints)
2. Dryness, defined as a pad weight of less than 1g on the 1-hour pad weight test
3. Significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 1-hour pad weight test
4. 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
5. 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)
6. Quality of life questionnaire assessed using the Kings Health Questionnaire (KHQ)
7. Urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test)
8. Dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test
9. Significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 24-hour pad weight test
10. Number of incontinence episodes/day recorded using a 3-day voiding diary
11. Number of pads used/day recorded using a 3-day voiding diary
12. Pelvic floor strength and quality of contraction measured using the Modified Oxford Score
13. Pelvic floor muscle function measured using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess volitional contractions (only carried out at one site Sonja Soeder, Germany)
Other secondary endpoints will be:
1. Time to achieve dryness (i.e. no record of any leaks) on the 3-day voiding diary
2. Compliance with the treatment protocol during the 12-week treatment programme
3. Safety in relation to adverse events and device deficiencies reported
4. Subject feedback on the device recorded by the Device Ease of Use Questionnaire following completion of the 12-week treatment programme
5. The Kings Health Questionnaire and Incontinence Quality of Life Questionnaire (I-QOL) will also be analysed at 9 and 12 months
6. A comparison of the 12 week Neurotech Vital device results with the 12 week modified Neurotech Vital device results
Overall trial start date
01/01/2014
Overall trial end date
01/04/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects who are female and at least 18 years of age.
2. Subjects who have signed informed consent form prior to any study related activity.
3. 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.
4. 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).
5. Subjects who 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 ≤ 40 kg/m2
7. Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
8. Subjects who are able to understand this study and are willing to complete all the study assessments.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
140
Participant exclusion criteria
1. Subjects who have an existing medical condition that would compromise their participation in the study.
2. Subjects who have a physical condition that would make them unable to perform the study procedures.
3. Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
4. Subjects with a history of an underlying neurological condition.
5. Subjects with a history of low back pain involving the spinal nerve root.
6. 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.
7. Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
8. 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).
9. Subjects with a clinical diagnosis of prolapse greater than Stage 2.
10. Subjects who are pregnant or could be pregnant.
11. Subjects who are less than 6 months post-partum or who are lactating.
12. Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
13. Subjects with pelvic pain or fibromyalgia or paravaginal defect.
14. Subjects with an active implanted medical device (i.e. pacemaker, pump etc).
15. Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months.
16. Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
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.
20. 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.
Recruitment start date
01/01/2014
Recruitment end date
01/04/2015
Locations
Countries of recruitment
Germany, United Kingdom
Trial participating centre
Bio-Medical Research Ltd
Galway
N/A
Ireland
Sponsor information
Organisation
Bio-Medical Research Ltd (Ireland)
Sponsor details
Parkmore Business Park West
Galway
N/A
Ireland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bio-Medical Research Ltd (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary