A prospective, multicenter, international clinical trial to assess the efficacy and safety of a novel wireless implantable tibial nerve stimulator for the treatment of patients with refractory overactive bladder (OAB): 3-years results

Digesu A1, Elneil S2, Heesakkers J P F A3, Van Kerrebroeck P4

Research Type


Abstract Category


Abstract 431
Scientific Podium Short Oral Session 22
Thursday 30th August 2018
14:00 - 14:07
Hall A
Clinical Trial Neuromodulation Neuropathies: Peripheral New Devices Overactive Bladder
1. Imperial College London, UK, 2. Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, UK., 3. Department of Urology 610, Radboud University Medical Center, Nijmegen, The Netherlands, 4. Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands.

Alex Digesu



Hypothesis / aims of study
To determine the long term safety and performance of a novel implantable tibial neurostimulation device (the BlueWind Medical RENOVA iStimTM System) for the treatment of OAB.
Study design, materials and methods
A wireless peripheral neurostimulator device (BlueWind Medical Ltd.) was implanted on the posterior tibial nerve approximately 5 cm above the medial malleolus and 2 cm posterior to the tibia in patients with refractory OAB. Local anaesthesia was used unless general anaesthesia was clinically indicated. The implant that electrically stimulates the tibial nerve is wirelessly powered by an external control unit (ECU). The ECU controls the therapeutic parameters and is worn by the patient during a specified treatment period whilst at home. A Physician Programmer is also used to remotely set individual stimulation parameters for each patient to optimize therapeutic outcome. 
Refractory OAB patients with symptoms of urinary frequency greater than 8 times/24 hours and/or urinary urgency leaks of at least 2 leaks/24 hours (both male and female) were enrolled, while those with clinically predominant stress urinary incontinence or those suffering from any neurological disease or disorder were excluded The efficacy and safety of BlueWind Medical RENOVA iStimTM system were assessed using a 3 day frequency volume chart, quality of life questionnaire (OAB-q) as well as clinical examination for up to 36-months post activation. The McNemar's test for paired proportions was applied to compare to the clinical improvement (i.e. ≥50% improvement in either number of urge-related incontinence episodes or number of urgent voids) at 6-months with that of longer follow-up periods.
A total of 36 patients were recruited for the original pilot study and were followed for 6 months post activation of the device. All 36 patients were implanted successfully with mean procedure duration of 34.8 minutes. These results have been previously reported.
Twenty-three OAB RENOVA iStim system implanted subjects were re-enrolled for the extended, 3-year follow-up study.  Up to date, 11 patients have reached 30-months follow-up. No SAEs were reported during the extended follow-up. In the per-protocol analysis, 9 of the 11 patients (82%) have shown more than 50% improvement in either number of urge-related incontinence episodes or number of urgent voids as compared to baseline. In the intent-to-treat analysis, 18 out of the 23 patients have shown above 50% improvement (78%).  
By August 2018, all of the patients are expected to reach their 36-month follow-up visit and final results will be presented.
Interpretation of results
BlueWind Medical RENOVA iStim system demonstrates long term safety and efficacy. When comparing the results of the long term follow-up to the 6-months follow-up, responders’ rates were similar at 6- and 30-months follow-up periods (74% and 78%, respectively).
Concluding message
The BlueWind Medical RENOVA iStim System for the treatment of OAB demonstrates safety as well as sustainable successful efficacy long-term results. A larger multicentre, international study is planned to confirm these promising preliminary data.
<span class="text-strong">Funding</span> This Trial was funded by BlueWind Medical Ltd <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Registration Number</span> ClinicalTrials.gov Identifier: NCT02299544 <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Imperial College London <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes