Stress urinary incontinence Urological and Genital Diseases Stress incontinence
Conditions
Interventions
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
Sponsors
Bio-Medical Research Ltd (Ireland)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 endpo | — |
Countries
Germany, United Kingdom
Outcome results
None listed