Plain English Summary
Background and study aims
Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens while running, jumping and lifting, or simply sneezing or coughing. There are various treatment options which can be tried to help with this condition and one which has been used over a number of years is electrical stimulation that contracts and relaxes the pelvic floor muscles, which in turn strengthens the muscles and improves SUI . There are different ways of giving this stimulation to the pelvic floor muscles. Different devices can provide this type of treatment. This study aims to look at and compare treatments of two different devices: Neurotech Vital device (NTV) and the itouch Sure Pelvic Floor Exerciser. The NTV is a device which uses external electrodes to supply the electrical stimulation to the pelvic floor muscles (this is by wrapping a garment around the bottom/buttocks and tops of the legs), which is connected to a device which when turned on supplies the electrical stimulation. The itouch Sure Pelvic Floor Exerciser is a device that uses internal electrodes (by way of a vaginal probe which is inserted into the vagina) to provide electrical stimulation to the pelvic floor muscles.
Who can participate?
Women who have been diagnosed with stress urinary incontinence (SUI)
What does the study involve?
The study involves 12 weeks of treatment with either device, which is decided randomly. Both devices are used according to the manufacturer's instructions for use. Both devices are used at home and participants are followed by a research nurse and a physiotherapist at the clinic halfway through the treatment (6 weeks) and at the end of the treatment (12 weeks).
What are the possible benefits and risks of participating?
It is hoped that participants get some benefit from participation in this study with an improvement in their symptoms. It cannot be promised that this study will help them but the information from this study will help improve the treatment of people with stress urinary incontinence. There are no expected risks to taking part.
Where is the study run from?
The Friarage Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2014 to May 2016
Who is funding the study?
Bio-medical Research Ltd (Ireland)
Who is the main contact?
Mrs Karen Robson
krobson@bmr.ie
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BMR-14-1001
Study information
Scientific title
A randomised, controlled, single-blind, pilot clinical study to evaluate the safety and performance of Neuromuscular Electrical Stimulation (NMES) with the NeuroTech Vital device compared to the itouch Sure Pelvic Floor Exerciser for the treatment of stress urinary incontinence in female patients
Acronym
NTV Pilot
Study hypothesis
To look at the safety and the performance of the Neurotech Vital device compared to the itouch Sure Pelvic Floor Exerciser, both used to treat Stress Urinary Incontinence in female subjects.
Ethics approval(s)
Not provided at time of registration - submission pending
Study design
Randomised controlled single-blind pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Uro-gynaecology (stress urinary incontinence - SUI)
Intervention
There are two arms to this study. Both are active treatments for SUI.
Neuromuscular Electrical Stimulation (NMES) with the Neurotech Vital device compared to the itouch Sure Pelvic Floor Exerciser.
Treatment duration: 12 weeks
Intervention type
Device
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Primary outcome measure
The proportion of subjects considered to have achieved significant improvement following the 1-hour pad weight test at 12 weeks compared to baseline. Significant improvement is defined as a greater than 50% reduction in pad weight from baseline.
Secondary outcome measures
The following secondary endpoints will be analysed at 6 and 12 weeks and at 6 months compared to baseline.
1. Urine leakage following a 1-hour pad weight test (following standardized bladder-filling protocol verified by ultrasound)
2. Dryness, defined as a pad weight of less than 1 g on the 1-hour pad weight test
3. Proportion of subjects considered to have achieved significant improvement, defined as a greater than 50% reduction in pad weight, from baseline on the 1-hour pad weight test (6 weeks and 6 months)
4. Reduction in pad weight on 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) and Kings Health Questionnaire (KHQ)
6. Urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test)
7. Dryness, defined as a pad weight of less than 1.3 g on the 24-hour pad weight test
8. Proportion of subjects considered to have achieved significant improvement, defined as a greater than 50% reduction in pad weight from baseline, on the 24-hour pad weight test
9. Number of incontinence episodes/day recorded using a 3-day voiding diary
10. Number of pads used/day recorded using a 3-day voiding diary
11. Pelvic floor strength and quality of contraction measured using the Modified Oxford Score
Other secondary endpoints will be:
11. Time to achieve dryness (i.e. no record of any leaks) on the 3-day voiding diary
12. Device compliance of the Neurotech Vital device with the treatment protocol during the 12-week treatment programme
13. Device compliance of the itouch Sure Pelvic Floor Exerciser with the treatment protocol during the 12-week treatment programme
14. Safety in relation to adverse events and device deficiencies reported
15. Subject feedback on the device recorded by the Device Ease of Use Questionnaire following completion of the 12-week treatment programme
16. Comparison of the 12 week Neurotech Vital device results with the 12-week itouch Sure Pelvic Floor Exerciser results.
Where appropriate, the above endpoints at 6 months will be compared to measurements at 12 weeks (completion of treatment programme).
Overall study start date
15/05/2014
Overall study end date
15/06/2015
Reason abandoned (if study stopped)
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 been clinically diagnosed with stress urinary incontinence and demonstrate a >2g and <90g urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test) at the baseline assessment
4. Subjects who have less than 10 voids in a 24-hour period on the 3 day voiding diary
5. Subjects who have scored less than 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
10
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 affecting urinary output
5. Subjects with any bladder abnormality that would affect the urinary flow through the urethra
6. Subjects with a history of low back pain involving the spinal nerve root
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 who have previously had pelvic floor radiation
10. Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months
11. Subjects with a clinical diagnosis of prolapse greater than Stage 2
12. Subjects who are pregnant or could be pregnant
13. Subjects who are less than 6 months post-partum or who are lactating
14. Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine
15. Subjects with an active implanted medical device (i.e. pacemaker, pump etc)
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
Recruitment start date
15/05/2014
Recruitment end date
15/06/2015
Locations
Countries of recruitment
Ireland, United Kingdom
Study participating centre
Bio-Medical Research Ltd
Galway
2
Ireland
Funders
Funder type
Research organisation
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|