Clinical trial NCT02214784: Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary Incontinence
SUI
Continence
Lead sponsor: Atlantic Therapeutics
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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:

1. 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).
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: All participants taking part in a standardised 1-minute stress test
timeFrame: 12 weeks
measure: All participants to complete a Quality of life questionnaire (I-QOL)
timeFrame: 12 weeks
Secondary outcomes:
measure: participants taking part in a 1 minute stress test
timeFrame: 4, 8, 12 and 26 weeks
measure: participants taking part in a 1-hour pad weight test
timeFrame: 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
measure: particpants taking part in the stress test and then having the pad weight to show loss of urine.
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: 1-hour pad weight test
timeFrame: 4, 8 and 12 weeks and at 6 months, for main and cohort part of the study
measure: quality of life questionnaire
timeFrame: 4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study
measure: quality of life questionnaire
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: 24 hour pad weight test
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: 24 hour pad weight test
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: 24hour pad weight test
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: 3-day diary card
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: 3-day voiding diary
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: Modified Oxford Score
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: Pelvic floor ultrasound
timeFrame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
measure: participants taking part in a 1 minute stress test
timeFrame: 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
Other outcomes:
measure: 3-day voiding diary
timeFrame: 6, 9 and 12 months
measure: device compliance download
timeFrame: 6, 9 and 12 months
measure: Device Ease of Use Questionnaire
timeFrame: 12 weeks cohort and main study
measure: We will collect from all participants the number of Adverse Events (AEs), Serious Adverse Events (SAEs), Serious Adverse Device Events (SADEs) and Uunexpected Adverse Device Events (UADE)and any Device Deficiencies.
timeFrame: Screening to 26 weeks
measure: Participants completing a Quality of life questionnaire
timeFrame: scores looked at from the questionnaires completed at 9 months and 12 months
Locations:
city: Berlin
country: Germany
facility: St Hedwig Krankenhaus
city: Brandenburg
country: Germany
facility: Klinikum Brandenburg,
city: Frankfurt
country: Germany
facility: St Joesph Hospital,
Study officials:
affiliation: St Hedwig Krankenhaus, Berlin
name: R Tunn, Professor
role: PRINCIPAL_INVESTIGATOR
References: