Symptoms of Overactive bladder / Overactive Bladder
Conditions
Interventions
In this study we will test the Closed Loop Medical SNS System (the Repose
System).
This is a rechargeable SNS system capable of operating as a traditional
open-loop SNS system or as a closed-loop sy
Sponsors
Saluda Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participant has a diagnosis of chronic OAB (> 12 months) and documented evidence from a 3-day bladder diary of >=4 involuntary leaks associated with urgency during the 3-day period. 2. Participant has tried and failed more conservative therapies (e.g. pelvic floor training and biofeedback) and is suitable to proceed to more advanced therapies, as determined by the Investigator. 3. Participant has been approved by the Investigator to undergo an SNS procedure. 4. Participant is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the Investigator. 5. Participant is on a stable dose (no new, discontinued, or changes in dose) of all medication to treat their OAB for at least 4 weeks prior to the implantation. 6. Participant is male or female, 18 years of age or older 7. Participant has residual bladder volume less than 150cc in Post-void Residual Volume Measurement test. 8. Participant is able and willing to comply with the protocol and follow-up. 9. Participant is fluent in the Dutch language. 10. Participant is able to provide written informed consent. Protocol page 6
Exclusion criteria
Exclusion criteria: 1. Participant has a primary diagnosis of stress incontinence (or mixed incontinence where the stress component overrides the urge component) 2. Participant has a concomitant diagnosis of neurogenic bladder syndrome. 3. Participant has a concomitant diagnosis of interstitial cystitis or bladder pain syndrome. 4. Participant has a pain complaint that forms a major component of their symptomatology which, in the opinion of the investigator, may confound reporting of OAB symptoms. 5. Participant has a urinary tract obstruction or urethral stricture. 6. Participant has a history of pelvic radiation or ongoing pelvic cancer. 7. Participant has a medical condition that could interfere with study procedures, accurate bladder function reporting and/or confound evaluation of study objectives (for example any clinical neurological condition such as Parkinson*s or Multiple Sclerosis), as determined by the Investigator. 8. Participant has a serious psychological disorder or other known mental health condition, based on medical history or in the opinion of the investigator (e.g. previously documented episodes of psychosis, documented suicide attempts). 9. Participant has a diagnosis of an uncontrolled coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease. 10. Participant has a diagnosis of type I or type II diabetes requiring insulin therapy. 11. Participant has previously failed an SNS therapy trial or had a full SNS system implanted. 12. Participant has an implanted pacemaker and/or another active implanted medical device that may interfere with the Repose SNS system. 13. In the previous 9 months, the participant has been treated with botulinum toxin injection for their OAB symptoms. 14. In the previous 3 months, the participant has been treated with tibial nerve stimulation for their OAB symptoms. 15. Participant has a condition currently requiring or likely to require the use of MRI, or high output ultrasound. 16. Participant has a life expectancy of less than 2 years. 17. Participant has a symptomatic active systemic or local infection including an active urinary tract infection (UTI) or has had more than 3 culture-proven UTI*s with an elevated leucocyte count in the previous 12 months. 18. Participant is allergic to, or has shown hypersensitivity to ethylene oxide or any materials of the neurostimulation system which come in contact with the body 19. Participant is pregnant or nursing (requires negative pregnancy test for women of childbearing potential). If female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal. 20. Within 6 months of enrolment, participant has had a significant untreated addiction to dependency-producing medications or has been a substance abuser (including alcohol and/or illicit drugs). 21. Participant is concomitantly participating in another clinical study, unless pre-approved by the Sponsor. 22. Participant is involved in an injury claim under current litigation in which relief of their OAB symptoms may be considered detrimental (i.e., secondary gains). Protocol page 7-8
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1) The incidence and severity of device or device procedure related Serious Adverse Events and Unexpected Adverse Device Effects when the device is in use. 2) All other possible device or device procedure related adverse events throughout the study duration including device deficiencies Performance 3) Detection of the electrophysiological components of the response to SNS will be captured by dichotomous choice (Yes/No). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in OAB symptoms (voiding frequency and control). 2) Changes in faecal urge and incontinence symptoms (voiding frequency and control). 3) Changes in lower urinary tract symptoms using the ICIQ-MLUTS (males) or ICIQ-FLUTS (females) questionnaire. 4) Changes in quality of life assessed using the ICIQ-OABqol and EQ-5D-5L. 5) Changes in sexual function assessed using the Sexual Function Questionnaire (optional). 6) Patient and clinician global impression of improvement assessed using the PGI-I and CGI-I, and participant satisfaction assessed using 5-point Likert scales. 7) System usability will be assessed with a short questionnaire (optional). 8) The safety and feasibility of applying closed-loop control in SNS assessed using device data, and adverse event reporting. 9) Electrophysiology of SNS assessed by analysing stimulation response at various locations along the lead. 10) Effect of postural change assessed by participant*s perceived changes in stimulation sensation during posture alterations and electrophysiology recordings during open-loop and closed-loop stimulation. 11) Participant*s device usage, compliance, and recharge data assessed using electrophysiology recordings, and device usage data. | — |
Countries
Australia, Belgium, Netherlands
Contacts
Public ContactDM Mugan
Saluda Medical
Outcome results
None listed