A study to look at the safety and performance of Neuromuscular Electrical Stimulation (NMES) with the NeuroTech Vital device compared to the itouch Sure Pelvic Floor Exerciser for the treatment of stress urinary incontinence

Not Applicable

Completed

• Conditions: ro-gynaecology (stress urinary incontinence - SUI); Urological and Genital Diseases; Stress incontinence

• Registration Number: ISRCTN27961345
• 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: 2014-03-10
• Study Completion: 2015-06-15
• Last Update Posted: 24 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified