Abstract: PD64-11
Sources of Funding: StimGuard supplied the stimulation devices.

Introduction

Percutaneous tibial nerve stimulation (PTNS) has been successfully used to treat symptoms of overactive bladder_x000D_ (OAB). PTNS currently relies on episodic stimulation of the tibial nerve once/week for 30min in an outpatient setting using an acupuncture needle and a ground pad to create electrical stimulation. We investigated CTNM in OAB patients using this new minimal invasive chronic implantable device (StimGuard LLC).

Methods

In 2014, two male patients (82y old with Parkinson's disease for 6y and 69y old with MS for 16 years) with neurogenic lower urinary tract dysfunction (nLUTD) received those implants. Both patients suffered from refractory UI and nocturia; detrusor overactivity and detrusor sphincter dyssynergia._x000D_ In February-April 2016, six additional patients (1 male: spina bifida; 5 female: iOAB) received the implants through a <5mm skin incision. Patients were asked to use the device while sleeping (max 8h). Patients were followed with bladder diary, maximum flow rate (ml/sec), post void residual (PVR) and questionnaires on a regular basis (1 month prior to surgery and 2, 4 weeks, 3 and 6 months postop).

Results

Implantation of the electrode was well-tolerated by all patients and performed as an outpatient procedure without perioperative complication. The initial two patients reported significant improvement of nLUTD within 48 hours. Both neurogenic patients were completely dry two months post-op; UI and nocturia disappeared (bladder diary). Both patients stopped CTNM due to the progression of their comorbidity, though a causal correlation could not be drawn. After 1.5 years the electrode of one patient migrated through the implantation path._x000D_ In the second group, the male was excluded due to lack of improvement and required an alternative treatment. Five female iOAB patients documented major improvements in their bladder diaries. UUI episodes significantly decreased (base: 2.1/day vs. 2.5/month 6 months post-op) and nocturia vanished. Mean voided volume significantly increased by 70ml, without or increased PVR. In the five iOAB patients, all implants are currently in place and their efficacy confirmed._x000D_

Conclusions

CTNM offers a promising treatment option using a novel chronic implantable device using an external charger. The new minimal_x000D_ invasive technology might revolutionize neuromodulation and offers those patients suffering from refractory OAB an opportunity to perform CTNM over several hours, even while sleeping with low or no stimulation related morbidities._x000D_

Funding

StimGuard supplied the stimulation devices.