Effectivity of a novel implantable tibial nerve stimulation device (stimrouter) for the treatment of overactive bladder syndrome: 30 months results of a multi-centre study

Khaneshi M1, Hajebrahimi S2, Javan A3, Rahnama'i M3

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 323
Open Discussion ePosters
Scientific Open Discussion Session 22
Friday 9th September 2022
13:55 - 14:00 (ePoster Station 2)
Exhibition Hall
Incontinence Neuromodulation New Devices Overactive Bladder Surgery
1. Society of Urological Research and Education (SURE), Heerlen, The Netherlands, 2. Research Center for Evidence-Based Medicine, faculty of Medicine,Iranian EBM Centre: A Joanna Briggs Institute (JBI) Center of Excellence, Tabriz University of Medical Sciences, Urology, Tabriz, Iran, 3. Uniklinik Aachen RWTH, Aachen, Germany
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Abstract

Hypothesis / aims of study
After failing conservative treatment alternatives for these patients such as behavioral modification and
pharmaceutical management, intravesical Botulinum toxin injection, sacral neuromodulation(SNM) and
percutaneous tibial nerve stimulation (PTNS) are well-established third-line treatment options. SNM and PTNS,
have not seen any significant improvement of the devices over the last decade or since FDA approval in 1997
In this study a new, battery - free implantable tined lead device ( StimRouter™ by Bioness ) in a multi - center study
is evaluated
Study design, materials and methods
From May 2019, 7 consecutive patients with urgency incontinence and detrusor over activity underwent a
procedure under local anesthesia in which a battery - free tined lead electrode was implanted on the medial side
of the ankle ( Figure 1 ). This lead was implanted by the same surgeon in all cases through a single 5 mm incision
and after the appropriate response of electrical stimulation, ( flexion of the first toe and paresthesia of the foot )
was looked. After identifying correct position, the lead was inserted through Seldinger technique and after a
final electrical check of the appropriate responses, subcutaneously tunneled for 10 cm in the proximal direction
of the medial side of the ankle. The total procedure time was 15 - 25 minutes. Patients were advised to stimulate
their tibial nerve with a hand - held remote at home for an hour per day. A hand - held remote allows patients to
control their symptoms by delivering gentle stimulating pulses to the Tibial Nerve to reduce the chronic urge to
urinate .
Results
All 7 patients reported an improvement in the urgency and incontinence episodes and a significant reduction of
incontinence - pad use after treatment . In addition, both day - time as well as night - time frequency was reduced in
all implanted patients ( Figure1 )
Interpretation of results
Our multi center data presented here are the first follow up data on feasibility and effect of the battery - free
implantable tibial nerve stimulation device ( Stimrouter ) for the treatment of urinary incontinence. There were no
adverse events and all implanted patients reported a significant improvement in urgency and incontinence
episodes as well as pad use and day - time and night - time frequency .
Concluding message
We can conclude that tibial nerve stimulation with Stimrouter could be a very promising therapy for patients with refractory idiopathic OAB and hope to develop this technology as soon as possible .
Figure 1
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee Tabriz University of Medical Sciences Helsinki Yes Informed Consent Yes
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