Remote programming in stage I sacral neuromodulation: a multicentre prospective feasibility study

Meng L1, Zhang Y1, Zhu W2, Wang Q2, Lu L3, Song W4, Zhang Y5, Li Y6

Research Type

Clinical

Abstract Category

Research Methods / Techniques

Abstract 783
Open Discussion ePosters
Scientific Open Discussion Session 108
Friday 25th October 2024
12:35 - 12:40 (ePoster Station 5)
Exhibition Hall
Neuromodulation Prospective Study Voiding Dysfunction Surgery
1. Beijing Hospital, 2. The First Affiliated Hospital of Zhengzhou University, 3. Sun Yat-sen University Sixth Affiliated Hospita, 4. Shandong Provincial Hospital, 5. The First Affiliated Hospital of Anhui Medical University, 6. Qilu Hospital of Shandong University
Presenter
Links

Abstract

Hypothesis / aims of study
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.
Study design, materials and methods
This prospective study was conducted at multiple high-level clinical SNM centres in China. Patients requiring SNM implantation were enroled 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 centres 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.
Interpretation of results
From a results perspective, remote programming achieved similar efficacy and user experience as in-person programming. Both important subjective symptom assessment scales and semiobjective voiding diaries showed similar changes between the two groups. Notably, patients in the remote programming group exhibited a more pronounced decrease in ICSI/ICPI scores. Further analysis revealed that this was mainly due to the presence of seven patients with IC in the RP group. Unfortunately, IC patients were not included in the OC group to explore the effects of RP on this specific population. However, upon analyzing the indicators in the RP group specifically among patients with IC, we observed that despite IC patients showing a greater degree of improvement in indicators compared to patients with other diagnoses in the same group, the comparison of efficacy indicators between the RP and OC groups, after excluding IC patients, still leads to similar conclusions. However, through a comparison with retrospective data from IC patients receiving conventional programming, we found that IC patients using remote programming may experience greater symptom improvement, suggesting that IC patients may have a higher programming demand.
In other results, our questionnaire survey showed that a significant proportion came from rural areas. And the survey also indicated that most patients chose to undergo sacral nerve modulation therapy due to refractory NLUTD, aligning with previous research. The economic cost of programming for most patients was not as high as initially imagined, but the time cost was substantial, underscoring the significant practical value of remote programming. Based on the experience of the remote programming system, the majority of participants reported that the remote system was a safe and satisfactory solution, worthy of wider adoption.
Concluding message
Through clinical implementation and patient feedback, this study formally demonstrates that remote programming is not inferior to in-person programming in terms of success rate, effectiveness, safety, and patient satisfaction. It supports the significant potential for the development and application of remote programming services for patients after Stage I surgery, which can provide efficient, cost-effective, and convenient programming services for a broader range of sacral nerve modulation patients.
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Disclosures
Funding National High Level Hospital Clinical Research Funding(BJ-2021-184) Clinical Trial No Subjects Human Ethics Committee Beijing Hospital Helsinki Yes Informed Consent Yes
11/12/2024 16:50:43