Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence

NCT02214784 | Completed

• 2 other identifiers: BMR-11-1002ISRCTN68358784
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary Incontinence; SUI; Continence

Outcome Measures

Primary Outcomes (2)

• All participants taking part in a standardised 1-minute stress test

  We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at baseline and then what it measures at 12 weeks after the 12 weeks treatment with the device. Comparing these against one another to look at any improvement.

  12 weeks

• All participants to complete a Quality of life questionnaire (I-QOL)

  We will look at the scores which are taken from these questionnaires (depending on which answer is ticked by the participant on the questionnaire) at baseline before treatment with the device commences and then again after 12 weeks of treatment with the device and compare the scores for any improvement.

  12 weeks

Secondary Outcomes (14)

• participants taking part in a 1 minute stress test

  4, 8, 12 and 26 weeks

• participants taking part in a 1-hour pad weight test

  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

• particpants taking part in the stress test and then having the pad weight to show loss of urine.

  4, 8 and 12 weeks and at 6 months for main and cohort part of the study

• 1-hour pad weight test

  4, 8 and 12 weeks and at 6 months, for main and cohort part of the study

• quality of life questionnaire

  4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study

Other Outcomes (5)

• 3-day voiding diary

  6, 9 and 12 months

• device compliance download

  6, 9 and 12 months

• Device Ease of Use Questionnaire

  12 weeks cohort and main study

Study Arms (2)

Active Neurotech Vital Device

ACTIVE COMPARATOR

50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30minutes over 12 weeks.

Device: Active Neurotech Vital

Modified Neurotech Vital Device

PLACEBO COMPARATOR

50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30 minutes over 12 weeks.

Device: Modified Neurotech Vital Device

Interventions

Active Neurotech Vital DEVICE

12 weeks treatment for 30 minutes per day, 5 days out of 7.

Active Neurotech Vital Device

Modified Neurotech Vital Device DEVICE

12 weeks treatment for 30 minutes per day for 5 days out of 7.

Modified Neurotech Vital Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlantic Therapeutics: lead

Study Sites (3)

St Hedwig Krankenhaus

Berlin, Germany

Location

Klinikum Brandenburg,

Brandenburg, Germany

Location

St Joesph Hospital,

Frankfurt, Germany

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• R Tunn, Professor

  St Hedwig Krankenhaus, Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: August 12, 2014
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

DE (3)