Remote programming in stage I sacral neuromodulation: a Multi-Center prospective feasibility study

Abstract

Objective: Sacral neuromodulation (SNM) has emerged as an effective therapy for refractory lower urinary tract dysfunction (LUTD). Remote programming holds promise in addressing the time and economic burdens associated with outpatient programming, especially for patients in the observation period following Stage I implant surgery (where the lead is implanted first without the pulse generator). The study aimed to explore the effectiveness and patient satisfaction of remote programming for Stage I SNM patients, and analyze the benefits patients gain from remote programming. Methods: This prospective study was conducted at multiple high-level clinical SNM centers in China. Patients requiring SNM implantation were enrolled and divided into two groups based on patient preference: remote programming (RP) group and outpatient control (OC) group. Patient attitudes toward RP were assessed through questionnaires, and the degree of symptom improvement was compared between the two groups to explore the usability of RP. Results: A total of 63 participants from 6 centers were included in the study, with 32 belonging to the RP group. The remote programming system presents a high level of usability (98%) and willingness (satisfaction rate: 96.83%) in result of questionnaire. RP showed a significant advantage in improving patients’ score of ICSI/ICPI (medianΔICSI/ICPI RP vs OC= -13.50 vs -2, P=0.015). And slightly ameliorate urinary symptoms such as pain (medianΔVAS RP vs OC= -1 vs 0, P= 0.164 ) and urgency ( medianΔOBASS -2.5 vs -1, P= 0,229), but the difference was not statistically significant. RP did not significantly impact the quality of life of patients (P=0.113), so do the rate of phase-two conversion (P= 0.926) or programming parameters. Conclusion: To the best of our knowledge, the presented study is the first multicenter research focusing on the remote programming of Stage I SNM patients. Through the clinical implementation and patient feedback, we demonstrate that remote programming is not inferior to in-person programming in terms of success rate, effectiveness, safety, and patient satisfaction.