None listed
Conditions
Brief summary
This study is a prospective feasibility study evaluating the implantation procedure and stimulation effects of tibial and/or saphenous nerve stimulation on patients with overactive bladder (OAB). Participants who meet the selection criteria will be enrolled in this study will be implanted with a neurostimulator system and randomised (2:1) to receive tibial or saphenous nerve stimulation. The purpose of this study is to evaluate the implantation procedure and stimulation paresthesia of tibial or saphenous nerve stimulation on patients with OAB using a commercial lead and the effects the stimulation has on symptoms of OAB. This study will help in the design a novel implanted stimulator and introducer and in the development of a larger scale study to evaluate the safety and effectiveness of the implant. All participants will receive stimulation for 5 consecutive days before having their lead removed and returning for a final follow-up visit 14 days post-removal. Participants will be assessed for number of bladder voids, paresthesia coverage & quality, quality of life and incidence of adverse events.
Interventions
Participants will undergo implantation of a neurostimulator lead under the skin of the lower leg, and randomised 2:1 to determine electrode position facing either the tibial nerve or subcutaneous tissue (saphenous nerve). An external peripheral nerve stimulator will be attached to the lead and stimulation testing will be conducted to optimise individual participant stimulation parameters as determined by the physician to deliver 2 hours of stimulation daily for 5 days, with an optional addition
Participants will undergo implantation of a neurostimulator lead under the skin of the lower leg, and randomised 2:1 to determine electrode position facing either the tibial nerve or subcutaneous tissue (saphenous nerve). An external peripheral nerve stimulator will be attached to the lead and stimulation testing will be conducted to optimise individual participant stimulation parameters as determined by the physician to deliver 2 hours of stimulation daily for 5 days, with an optional additional stimulation period of 10 days. The external peripheral nerve stimulator and lead will be dressed in a waterproof dressing and instructions provided to the patient on care for the dressing, with weekly visit to the site for a dressing change. Stimulation compliance will be monitored through neurostimulator analytics. The lead will be removed following the last day of stimulation.
Sponsors
Five Corners Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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. 11. If on current medications, be on a stable dose (no new, discontinued, or change in dose) of all prescribed medication for at least 4 weeks prior to the trial 12. Females of childbearing age must have a negative urine pregnancy test at baseline
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 11. PTNS treatment in the previous 12 weeks prior to enrollment 12. Use of investigational drug/device therapy within past 4 weeks 13. Be concomitantly participating in another clinical study. 14. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit 15. Pregnancy 16. Have prior surgical or trauma scar tissue in the target area for lead implantation
Outcome results
None listed