Objective: Safety and performance of the C-Life Investigational Electrode, and to determine the clinical value for conditional dorsal genital nerve stimulation in patients with overactive bladder syndrome.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and performance of the C-life Investigational Electrode.
Secondary outcome
Secondary outcomes:
Decrease in number or severity of incontinence episodes per 24 h >50% of
baseline status.
To record the electrode voltages during stimulation and the electrochemical
impedance spectra
Background summary
Rationale: Symptoms of overactive bladder syndrome with or without detrusor
overactivity decrease quality of life, and not all patients respond
satisfactorily to conservative therapies. Subject-controlled, on-demand, dorsal
genital nerve stimulation could be an alternative.
Recently we conducted a pilot study on subject-controlled, on-demand, dorsal
genital nerve stimulation with a test-electrode and obtained good results.
Unfortunately with this test-electrode, it was not possible to fixate it
internally, and it didn*t stay in the proper position over a longer period, in
some subjects not even for the complete study period. A new electrode has been
developed, the C-Life Investigational Electrode, that will fixate in the tissue
surrounding the nerve in order to minimize the potential for migration of the
electrode in the tissue.
Study objective
Objective: Safety and performance of the C-Life Investigational Electrode, and
to determine the clinical value for conditional dorsal genital nerve
stimulation in patients with overactive bladder syndrome.
Study design
Study design: Pilot study.
Intervention
Patients will complete voiding diaries and a padtest for 3 days prior to the
date of investigation. Patients will also complete an Urgency Severity Score
sheet. The C-Life Investigational Electrode will be implanted under local
anesthesia adjacent to the dorsal genital nerve. It is connected
percutaneously to the C-Life Investigational Stimulator, which is a modified
version of the CE-marked MyGait Stimulator from Ottobock. Patients will be able
to activate the stimulator on conditional basis. The implant will be explanted
after 7 days. Patients will complete voiding diaries/padtest and once a day an
Urgency severity Score during the stimulation period and for 3 days after
explanation.
The stimulation threshold, the electrode voltage, and the impedance will be
examined after implantation and before removal of the electrode
Study burden and risks
At the first visit, information about the study and intervention will be given.
The study intervention, with electrical stimulation, will be done at the second
visit. The third visit is to explant the electrode. The patients don*t have any
direct benefit, besides a reimbursement of travelling expenses and a gift
coupon (ยค50,-). The risk of the adverse events is thought to be minimal,
because no vital organs are in the area of insertion. Possible risks are
temporary pain due to the electrode insertion and/or infection at the site of
stimulation and puncture, and vascular or nerve damage by electrode insertion.
Sofiendalsvej 85
Aalborg SV 9200
DK
Sofiendalsvej 85
Aalborg SV 9200
DK
Listed location countries
Age
Inclusion criteria
urgency urinairy incontinence
Exclusion criteria
neurological disease that cause the urgency urinairy incontinence
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53729.091.15 |