ACTRN12618001582246
Completed
未知
A prospective feasibility study evaluating the implantation procedure and stimulation effects of tibial and/or saphenous nerve stimulation on patients with overactive bladder (OAB)
Five Corners Pty Ltd0 sites3 target enrollmentSeptember 24, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Overactive bladder
- Sponsor
- Five Corners Pty Ltd
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males and females who are 18\-75 years of age at the time of enrollment
- •2\.Be willing and capable of giving informed consent
- •3\.Be willing and able to comply with study\-related requirements, procedures.
- •4\.Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •5\.Have been diagnosed with OAB
- •6\.Have an average of 10 or more frequency events per day in a 3\-Day Voiding Diary
- •7\.Have 2 or more urinary incontinence episodes in a 3\-Day Voiding Diary
- •8\.Will be able to provide clear, thoughtful responses to questions and questionnaires
- •9\.Be able to toilet self and have and maintain personal hygiene
- •10\.Be able to sense and tolerate tibial nerve stimulation.
Exclusion Criteria
- •1\.Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, neuropathy or uncontrolled diabetes mellitus
- •2\.Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
- •3\.Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
- •4\.Have a condition currently requiring or likely to require the use of MRI or diathermy
- •5\.Be at risk for an infection or have an active systemic or local infection
- •6\.Have a current Urinary Tract Infection
- •7\.Be unable to keep the dressing clean during and in between visits.
- •8\.Be currently using a marketed device for treatment of their incontinence (including but not limited to Interstim®)
- •9\.Have had Botox treatment for their OAB in the previous 4 months.
- •10\.Have Current use of TENS in pelvic region, back or legs
Outcomes
Primary Outcomes
Not specified
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