Percutaneous tibial nerve stimulation (PTNS) has been successfully used to treat symptoms of overactive bladder (OAB). PTNS relies on episodic stimulation of the tibial nerve once a week for 30 minutes, commonly performed in an outpatient setting. A novel minimal invasive chronic implant (StimGuard LLC®) allows stimulation of the tibial nerve for several hours while the patient sleeps, which might transform PTNS. After an initial 3 month study of 4 patients suffering from OAB in Mexico in 2013, where a reduction of the urgency index was documented, we report on tibial neuromodulation using this new chronic implantable device.
In 2014, two males with neurogenic lower urinary tract dysfunction (nLUTD); an 82y old patient (Parkinson’s disease for 6y) and a 69y old patient (multiple sclerosis for 16y) were implanted with this new minimal invasive device. Both patients suffered from refractory urgency incontinence and nocturia; detrusor overactivity and detrusor sphincter dyssynergia were demonstrated during video-urodynamics. In 2016, 5 further patients suffering from OAB, were implanted under local anesthesia with an incision of 5mm.
Implantation of this novel electrode was well-tolerated and performed as outpatient surgery. The initial 2 patients reported a significant improvement of nLUTD within 48 hours. Two months after surgery, patients were completely dry; urinary urgency and nocturia disappeared according to their bladder diary. Due to this reported implantation success, stimulation was continued only during sleep (nighttime). Urodynamic follow-up at 2 months follow-up documented a significant increase of maximum cystometric capacity; no DO was detected. In our most recent group, 3 of 5 patients reported that symptoms were resolved 2 weeks postoperative. Nocturia normalized during this time and urgency decreased significantly. No implant-related adverse events were reported.
Tibial neuromodulation using a novel chronic implantable device introduces a promising treatment option with minimal-invasive technology that is urgently needed for patients suffering from refractory OAB or even from multiple problems. This new technology can be performed under local anesthesia and offers the opportunity for the patient to perform chronic tibial neuromodulation for several hours over 24h, even while sleeping. Further investigations are planned to determine the how much time is required to ensure the best effect. This new device might revolutionize neuromodulation procedures.