After failing conservative treatment alternatives for these patients such as behavioral modification and pharmaceutical management, intravesical Botulinum toxin (Botox) 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.

From May 2019, 8 consecutive patients with urgency incontinence and detrusor over activity and also in May 2022, 1 patient with cystitis 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 to 25 minutes. Patients were advised to stimulate their tibial nerve with a hand held remote at home for an hour per day.

All 9 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. The patient with diagnosed cystitis reported reduction of pain after 6th week of use. (Figure1)

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.

We can conclude that tibial nerve stimulation with Stimrouter could be a very promising therapy for patients with refractory idiopathic OAB and we should follow up the patient with cystitis to achieve more hopeful results. This device has many advantages in comparison with Sacral Neuromodulation (SNM) device and can be expanded in the near future.

Continence 7S1 (2023) 100931
DOI: 10.1016/j.cont.2023.100931