Continence Achieved through Recording of Electrophysiology (CARE) Study: A Prospective Study to Evaluate the Safety and Feasibility of using the Closed Loop Medical Sacral Nerve Stimulation System in the treatment of symptoms of Overactive Bladder.

Not Applicable

Recruiting

• Conditions: Symptoms of Overactive Bladder (OAB); Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12622000999730
• Lead Sponsor: Closed Loop Medical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Participants in this study must meet all of the following inclusion criteria, as determined by the Investigator:
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 one or more conservative therapies (e.g. drug therapy, diet/lifestyle modification, pelvic floor physiotherapy (including bladder re-training), biofeedback, osteopathy, acupuncture) 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 English language.
10. Participant is able to provide written informed consent.

Exclusion Criteria

Participants in this study must not meet any of the following exclusion criteria, as determined by the Investigator:
1. Participant has a primary diagnosis of stress incontinence (or mixed incontinence where the stress component overrides the urgency component)
2. Participant has a concomitant diagnosis of neurogenic bladder.
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 endpoints, as determined by the Investigator.
8. Participant has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of disease, compliance with intervention and/or ability to evaluate treatment outcomes.
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 infection or local infection including an active urinary tract infection (UTI), or has had more than three culture-proven UTI’s in the previous 12 months.
18. Participant is allergic 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified