Safety and performance of Neuromuscular Electrical Stimulation (NMES) with the Neurotech Vital device for the treatment of stress urinary incontinence (SUI)

Not Applicable

Completed

• Conditions: Stress urinary incontinence; Urological and Genital Diseases; Stress incontinence

• Registration Number: ISRCTN68358784
• Lead Sponsor: Bio-Medical Research Ltd (Ireland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-30
• Study Completion: 2015-04-01
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 140

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 previously failed a 6 week volitional pelvic floor muscle training programme or in the Investigators opinion an equivalent lifestyle and exercise programme
4. 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)
5. Subjects who 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 = 40 kg/m2
7. Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained
8. Subjects who are able to understand this study and are willing to complete all the study assessments

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
5. Subjects with a history of low back pain involving the spinal nerve root
6. 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
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 with a clinical diagnosis of prolapse greater than Stage 2
10. Subjects who are pregnant or could be pregnant
11. Subjects who are less than 6 months post-partum or who are lactating
12. Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine
13. Subjects with pelvic pain or fibromyalgia or paravaginal defect
14. Subjects with an active implanted medical device (i.e. pacemaker, pump etc)
15. Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months
16. Subjects with an injury or disability affecting any part of their body which will be in contact with the garment
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
20. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified