Hypothesis / aims of study
Sacral neuromodulation (SNM) has emerged as an exciting treatment strategy for patients suffering from lower urinary tract symptoms (LUTS), being an established approach in overactive bladder (OAB), chronic non-obstructive urinary retention (CUR) and chronic pelvic pain (CPP) refractory to standard therapies. Device reprogramming is often necessary to tailor treatment to individual needs and optimize outcomes, yet data on reprogramming patterns and their impact remain limited. This study aims to assess the necessity of reprogramming, its association with clinical indications and patient satisfaction following adjustments.
Study design, materials and methods
This prospective, real-world, non-interventional cohort study included patients with LUTS who underwent the definitive phase of SNM by an expert in Functional Urology, between 2018 and 2025. Data collected included patient demographics, clinical indication for SNM, device type, initial programming settings, and reprogramming frequency. Patient satisfaction following successful reprogramming was assessed using a 5-point Likert scale, where 1 indicated slight improvement and 5 represented complete resolution of symptoms. Statistical tests included Chi-square and Kruskal-Wallis test, conducted using SPSS version 30.
Results
Among 61 patients who underwent SNM, 55 had adequate follow-up (mean age 48 years [SD 16.2], 65.5% female, mean follow-up duration 29.8 months [SD 19.8]). The primary indications were OAB (54.5%), neurogenic overactive bladder (NOAB) (21.8%), CUR (20.9%) and CPP (3.6%). The most common device was InterStim™ II (67.3%), followed by InterStim™ Micro (23.6%) and InterStim™ X (9.1%). The most frequent initial programming settings were -0+3|210μs|14Hz|1,4 V (median value).
Reprogramming was required in 41 patients (74.5%), with a median of 2 adjustments (IQR 2). Electrode configuration was the most frequently modified parameter (53.7%, median 1, IQR 1), followed by pulse frequency (36.6%, median 0, IQR 1) and pulse width (24.4%, median 0, IQR 1). Stimulation amplitude was adjusted in all cases according to patient’s discretion. Chi-square analysis showed no significant association between disease indication and reprogramming necessity (p = 0.885). The Kruskal-Wallis test revealed that disease indication influenced reprogramming frequency (p = 0.01), though post-hoc comparisons lacked statistical significance.
Subgroup analysis revealed that 60.9% of idiopathic OAB patients required more than two reprogrammings, while all NOAB patients had two or fewer. All CPP patients needed more than two reprogrammings.
In terms of patient outcomes, median satisfaction score was 3 (IQR 3), but 17% of patients, exclusively those with OAB, reported no clinical improvement.
Interpretation of results
The findings underscore the pivotal role of reprogramming in optimizing SNM therapy and contributing to positive clinical outcomes. The necessity and frequency of reprogramming varied by indication, with OAB requiring more frequent adjustments and NOAB fewer, although post-hoc analysis did not confirm statistical significance. Electrode configuration was the most frequently modified parameter, highlighting its role in therapy optimization and the relevance of bipolar and monopolar adjustments. Overall, SNM reprogramming proved effective in most patients, as reflected in the median satisfaction score of 3. However, a subset of idiopathic OAB patients experienced no clinical benefit, reflecting the broad spectrum of pathophysiological mechanisms behind the condition and potentially suggesting underlying phenotypic variations and challenges in neuromodulation response for this group.