Condition category
Urological and Genital Diseases
Date applied
24/02/2014
Date assigned
10/03/2014
Last edited
10/03/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
The study is open to 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 - so there is a 50% chance of you getting either of the devices for a period of 12 weeks. Both devices will be used according to the manufacturer’s instructions for use. Both devices will be used at home and participants will be followed by a research nurse and a physiotherapist at the clinic half way 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 will get some benefit from participation in this study with an improvement in their symptoms. However, we cannot promise that this study will help them but the information we get 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, Northallerton, North Yorkshire, DL6 1JG, UK.

When is the study starting and how long is it expected to run for?
This study will start in May 2014 and run until May 2016.

Who is funding the study?
Bio-medical Research Ltd., 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
2
Ireland

Additional identifiers

EudraCT 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

We do not have ethical approval yet. Submission to be finalised by the end of February 2014. An ethical meeting will be applied for March 2014.

Study design

Randomised, controlled, single blind pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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 - 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

Phase

Not Applicable

Drug names

Primary outcome measures

The primary endpoint is defined as the proportion of subjects considered to have achieved ‘significant improvement’ following the 1-hour pad weight test at 12 weeks compared to baseline.

‘Significant improved’ 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 trial start date

15/05/2014

Overall trial end date

15/06/2015

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 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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial participating centre

Bio-Medical Research Ltd
Galway
2
Ireland

Sponsor information

Organisation

Bio-Medical Research Ltd (Ireland)

Sponsor details

Parkmore Business Park West
Galway
2
Ireland

Sponsor type

Industry

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes