Efficacy and safety of optical navigation system versus conventional fluoroscopy in sacral neuromodulation electrode implantation: a prospective randomized controlled trial

Background Precise Stage I electrode implantation is critical for the success of sacral neuromodulation (SNM); however, conventional fluoroscopy-guided puncture is limited by reliance on bony landmarks and significant radiation exposure. This study evaluated the clinical value of an optical navigation system (ONS) combined with multimodal image fusion for SNM electrode implantation. Methods A prospective, single-blind, randomized controlled trial was conducted between March 2024 and June 2025. Eighty patients with refractory lower urinary tract dysfunction (including neurogenic bladder, overactive bladder, and interstitial cystitis/bladder pain syndrome) undergoing SNM were randomly assigned (1:1) to receive either ONS-assisted puncture (experimental group, n = 40) or conventional X-ray guidance (control group, n = 40). The primary outcome was the conversion rate to Stage II permanent implantation. Secondary outcomes included the number of puncture attempts, puncture time, total operative time, radiation dose, minimum effective voltage, and perioperative complications. Results Baseline characteristics were comparable between groups. The Stage II conversion rate was significantly higher in the ONS group than in the control group (87.5% vs. 62.5%, P < 0.05). Patients in the ONS group required fewer median puncture attempts [2.0 (2.0, 2.2) vs. 5.0 (4.0, 7.0), P < 0.01] and shorter puncture time [7.5 (5.8, 10.2) min vs. 16.0 (12.0, 25.0) min, P < 0.01]. Intraoperative radiation exposure was substantially reduced in the ONS group [145.5 (108.4, 202.3) mGy vs. 473.3 (354.5, 635.2) mGy, P < 0.01]. Furthermore, the minimum effective voltage was significantly lower in the ONS group [1.8 (1.8, 2.5) V vs. 2.8 (1.8, 3.0) V, P = 0.010], suggesting superior electrode-neural positioning accuracy. No surgical complications occurred in either group. Conclusions ONS combined with multimodal image fusion significantly improves the precision of SNM electrode implantation, reduces surgical trauma and radiation exposure, and increases Stage II conversion rates. This technique demonstrates stable clinical efficacy across various etiologies of refractory lower urinary tract dysfunction and represents a valuable navigation tool warranting broader clinical adoption. Trial registration Chinese Clinical Trial Registry #ChiCTR2500098093 3/3/2025.