Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2‐year clinical outcomes and sensory responses to lead stimulation

Objectives To assess clinical follow‐up data over 24 months, comparing the use of a curved vs straight stylet in patients undergoing sacral neuromodulation using the standardized tined lead implantation technique. Patients and Methods We conducted a single tertiary‐centre, prospective study between August 2013 and June 2015 involving 40 patients with overactive bladder and 15 with non‐obstructive urinary retention refractory to first‐line treatment. The primary outcome was successful tined lead procedure according to intention‐to‐treat analyses at 12 and 24 months. The secondary outcome was number of optimal electrode configurations during programming. Statistical analysis was performed using plain non‐parametric tests for numerical and categorical data. Results Successful tined lead procedures were achieved in 33 of 35 patients (94%) implanted with the curved stylet compared with 13 of 20 patients (65%) implanted with the straight stylet (P = 0.005). Intention‐to‐treat analyses at 12 and 24 months showed success rates of 94% and 91%, respectively, in the curved stylet group vs 65% and 45%, respectively, in the straight stylet group (P = 0.002 and P < 0.001). In the curved stylet group, 60% and 25% of the electrode configurations were considered optimal and poor, respectively, vs 40% and 37%, respectively, in the straight stylet group (P < 0.001). Conclusions The use of the standardized implantation technique with the curved stylet led to more successful tined lead procedures, better success rates after 2 years of follow‐up and a greater number of optimal electrode configurations when compared to use of the straight stylet.