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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>1) The incidence and severity of device or device procedure related Serious<br /><br>Adverse Events and Unexpected Adverse Device Effects when the device is in use.<br /><br>2) All other possible device or device procedure related adverse events<br /><br>throughout the study duration including device deficiencies<br /><br>Performance<br /><br>3) Detection of the electrophysiological components of the response to SNS<br /><br>will be captured by dichotomous choice (Yes/No).</p><br>

Secondary Outcome Measures