Uro-gynaecology (stress urinary incontinence - SUI) Urological and Genital Diseases Stress incontinence
Conditions
Interventions
There are two arms to this study. Both are active treatments for SUI.
Neuromuscular Electrical Stimulation (NMES) with the Neurotech Vital device compared to the itouch Sure Pelvic Fl
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 been clinically diagnosed with stress urinary incontinence and demonstrate a >2g and <90g urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test) at the baseline assessment 4. Subjects who have less than 10 voids in a 24-hour period on the 3 day voiding diary 5. Subjects who have scored less than 9 out of 18 for the Urge 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 6. Subjects with a Body Mass Index of = 35 kg/m2 7. Subjects of child-bearing potential who are using a highly effective contraceptive method (established use of oral, injected, implanted hormonal method of contraception or barrier method of contraception with spermicide) 8. Subjects who are willing not to seek any other treatment for stress incontinence during the study period 9. Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained 10. 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 affecting urinary output 5. Subjects with any bladder abnormality that would affect the urinary flow through the urethra 6. Subjects with a history of low back pain involving the spinal nerve root 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 who have previously had pelvic floor radiation 10. Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months 11. Subjects with a clinical diagnosis of prolapse greater than Stage 2 12. Subjects who are pregnant or could be pregnant 13. Subjects who are less than 6 months post-partum or who are lactating 14. Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine 15. Subjects with an active implanted medical device (i.e. pacemaker, pump etc) 16. Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects considered to have achieved ?significant improvement? following the 1-hour pad weight test at 12 weeks compared to baseline. ?Significant improvement? is defined as a greater than 50% reduction in pad weight from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be analysed at 6 and 12 weeks and at 6 months compared to baseline. 1. Urine leakage following a 1-hour pad weight test (following standardized bladder-filling protocol verified by ultrasound) 2. Dryness, defined as a pad weight of less than 1 g on the 1-hour pad weight test 3. Proportion of subjects considered to have achieved significant improvement, defined as a greater than 50% reduction in pad weight, from baseline on the 1-hour pad weight test (6 weeks and 6 months) 4. Reduction in pad weight on 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) and Kings Health Questionnaire (KHQ) 6. Urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test) 7. Dryness, defined as a pad weight of less than 1.3 g on the 24-hour pad weight test 8. Proportion of subjects considered to have achieved significant improvement, defined as a greater than 50% reduction in pad weight from baseline, on the 24-hour pad weight test 9. Number of incontinence episodes/day recorded using a 3-day voiding diary 10. Number of pads used/day recorded using a 3-day voiding diary 11. Pelvic floor strength and quality of contraction measured using the Modified Oxford Score Other secondary endpoints will be: 11. Time to achieve dryness (i.e. no record of any leaks) on the 3-day voiding diary 12. Device compliance of the Neurotech Vital device with the treatment protocol during the 12-week treatment programme 13. Device compliance of the itouch Sure Pelvic Floor Exerciser with the treatment protocol during the 12-week treatment | — |
Countries
United Kingdom
Outcome results
None listed