A study to look at 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
| ISRCTN | ISRCTN27961345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27961345 |
| Secondary identifying numbers | BMR-14-1001 |
- Submission date
- 24/02/2014
- Registration date
- 10/03/2014
- Last edited
- 14/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Scientific
Bio-Medical Research Ltd
Parkmore Business Park West
Galway
2
Ireland
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 10 |
| 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 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
2
Ireland
Sponsor information
Industry
Parkmore Business Park West
Galway
2
Ireland
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/08/2020: No publications found.
09/08/2017: No publications found, verifying study status with principal investigator.
