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

INTERVENTION: Screening, visit 1: patients are assessed for eligibility Baseline visit 2: week 0 ‐ patients are randomized to either get the Neurotech Vital (active group) or the modified Neurotech Vital (control group), 12 weeks treatment with either device Follow up visit 3: 4 weeks later Follow up visit 4: 8 weeks Follow up visit 5: 12 weeks ‐ end of treatment. Patients are asked if they are happy with the treatment they received ? if no, they are un‐blinded and if they were allocated the modified device they can have a further 12 weeks treatment. If they had the active device they continue on to kegels and visit 6 (14 weeks later) and telephone call 7 and telephone call 8. Patients who have a further 12 weeks treatment will go back to visit 0 baseline and continue right through to the telephone call 8. CONDITION: Stress urinary incontinence ; Urological and Genital Diseases ; Stress incontinence PRIMARY OUTCOME: 1. Reduction from baseline to 12 weeks in urine leakage following a standardised 1‐minute stress test at 1 hour post‐bladder filling protocol (1‐hour pad weight test); 2. Improvement from baseline to 12 weeks in quality of life, assessed using the Incontinence Quality of Life Questionnaire (I‐QOL) 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 SECONDARY OUTCOME: The following secondary endpoints will be analysed for the main and the cohort study at 4, 8 and 12 weeks and at 6 months compared to baseline. ; 1. Urine leakage following a 1‐minute stress test at 1 hour post‐bladder filling protocol (1‐hour pad weight test) (except for the 12 week assessment which is one of the primary endpoints); 2. Dryness, defined as a pad weight of less than 1g on the 1‐hour pad weight test; 3. Significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 1‐hour pad weight test; 4. Reduction in pad weight on the 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) (except for the 12 week assessment which is one of the primary endpoints); 6. Quality of life, assessed using the Kings Health Questionnaire (KHQ) ; 7. Urine leakage experienced by the subject at home during a 24‐hour period (24‐hour pad weight test); 8. Dryness, defined as a pad weight of less than 1.3g on the 24‐hour pad weight test; 9. Significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 24‐hour pad weight test; 10. Number of incontinence episodes/day, recorded using a 3‐day voiding diary; 11. Number of pads used/day, recorded using a 3‐day voiding diary; 12. Pelvic floor strength and quality of contraction, measured using the Modified Oxford Score; 13. Pelvic floor muscle function, measured using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess volitional contractions (only carried out at one site ? Sonja Soeder, Germany); ; Other secondary endpoints will be:; 1. Time to achieve dryness (i.e. no record of any leaks) on the 3‐day voiding diary; 2. Compliance with the treatment protocol during the 12‐week treatment programme; 3. Safety in relation to adverse events and device deficiencies reported; 4. Subject feedback on the device recorded by the Device Ease of Use Questionnaire following completion of the 12‐week treatment programme; 5. The Kings Health Questionnaire and Incontinence Quality of Life Questionnaire (I‐QOL) at 9 and 12 months; 6. A comparison of the 12 week Neurotech Vital device results with the 12 week modified Neurotech Vital device results