None listed
Conditions
Brief summary
Closed Loop Medical has developed a neuromodulation and recording system capable of recording the electrophysiological response to each stimulus pulse. Closed Loop Medical have adapted a commercially available Spinal Cord Stimulation system approved for treatment of chronic intractable pain of the trunk and/or limbs to provide a fully implantable SNS system akin to those commercially available but, which can also use the recorded electrophysiological response from the sacral nerves to drive a feedback-controlled closed-loop therapy and aid in nerve targeting. This study is designed to assess the feasibility and safety of the Closed Loop Medical SNS System in the treatment of symptoms of OAB.
Interventions
The intervention in this trial consists of the implantation of and electronic active medical device, a sacral nerve stimulator, known as the Repose Sacral Nerve Stimulator with implantable leads, which is aimed to reduce symptoms of overactive bladder. The trial is done in 2 stages. During the first stage, leads are implanted near the sacral nerves and connected to an external trial stimulator for a duration of 14-30 days. The surgery in this stage takes about 1 hour and is performed under compl
The intervention in this trial consists of the implantation of and electronic active medical device, a sacral nerve stimulator, known as the Repose Sacral Nerve Stimulator with implantable leads, which is aimed to reduce symptoms of overactive bladder. The trial is done in 2 stages. During the first stage, leads are implanted near the sacral nerves and connected to an external trial stimulator for a duration of 14-30 days. The surgery in this stage takes about 1 hour and is performed under complete anaesthesia. If the system is deemed to appropriately reduce the symptoms of overactive bladder, a permanently implanted stimulator is implanted during a second stage procedure which takes about 1 hour under complete anaesthesia. Both procedures are performed by qualified urologists, urogynaecologists, gynaecologists, or similarly qualified investigators. Stimulation will commence after the participant has recovered from surgery. Stimulation parameters will be within ranges normally used for Sacral Nerve Stimulation (SNS), typically stimulating with charge-balanced pulses near an amplitude of 2mA, a pulse width of 210 us and a frequency of 14Hz. The participants are followed up for a duration of 2 years with scheduled visits at 1, 3, 6, 9, 12, 18, and 24 months after the permanent implantation surgery. Prior to the scheduled visits, the study sites will call the participants to ensure compliance with the study requirements and investigate the need for troubleshooting. At the end of the trial, the participants can elect to keep their stimulator and will continue to receive standard care.
Sponsors
Closed Loop Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
Outcome results
None listed