Pediatric sacral nerve stimulator explanation due to complications or cure: a survival analysis.

INTRODUCTION: Historically, there have been few treatment options for children with severe refractory bladder and bowel dysfunction (BBD). Sacral neuromodulation (SNM) continues to show promising results in this challenging pediatric population with recalcitrant lower urinary tract symptoms. At the authors institution, they have begun offering explantation to those with persistent improvement after >6 months of having device turned off. The authors hypothesized that (1) SNM explantation for cure increases with extended follow-up and (2) those explanted for cure would have improved symptoms and quality of life when compared to those explanted for complication. MATERIALS & METHODS: The authors retrospectively reviewed all consecutive patients aged <18 years who underwent SNM placements at their institution (2012-2017). They excluded those without the second stage procedure. Reasons for device explantation were categorized as cure (resolution of symptoms with the device turned off for at least 6 months) or a complication (e.g. infection, need for magnetic resonance imaging, or pain). Non-parametric tests and survival analysis were used for analysis to account for differential follow-up time. Of those explanted, surveys were electronically sent to assess BBD severity and overall quality of life. RESULTS: Of 67 children who underwent a first stage procedure, 62 (92.5%) underwent a second stage procedure. 61 met inclusion criteria (68.9% female, 29.5% with previous filum section, median age at implantation 10.3 years). During follow-up (median 2.3 years), 12 patients (19.7%) had the SNM exchanged/revised because of lead fracture/breakage and return of urinary symptoms. To date, 50 patients remain with their SNM implanted, and 11 have been explanted. Adjusting for follow-up time, the risk of explantation was 6.5% at 2 years (2.2% for cure, 4.3% for complications) (Figure 1). Explantation increased to 24.5% at 3 years (16.5% for cure, 8.0% for complications) and 40.4% at 4 years (32.4% for cure, 8.0% for complications). Questionnaires were collected on patients after explant (median 2.2 years), with improvement in those explanted for cure compared to complication (Figure 2). DISCUSSION: Sacral neuromodulation explantation for cure is a novel concept previously not described in the literature. Limitations of this study include the relatively small numbers and lack of objective data in the cohort that remains with SNM device implanted. CONCLUSION: Sacral neuromodulation is a safe, viable option for the pediatric patient with refractory bladder dysfunction. Furthermore, SNM explantation for cure is an option with increasing likelihood after 2 years.

Ambulatory patients with spina bifida are 50% more likely to be fecally continent than non-ambulatory patients, particularly after a MACE procedure.

INTRODUCTION: While fecal incontinence (FI) affects many patients with spina bifida (SB), it is unclear if it is associated with ambulatory status. OBJECTIVE: To determine if ambulatory status is associated with FI, and a potential confounding variable, in patients with and without a Malone antegrade continence enema (MACE). STUDY DESIGN: This study retrospectively reviewed of patients aged ≥8 years with SB who were enrolled in an international quality of life study at outpatient visits (January 2013 to September 2015). Patients reported FI over the last 4 weeks (strict criteria: any FI/accidents vs no FI). Patients unable to self-report FI due to developmental delay were excluded. Those who were ambulating outdoors with/without braces/crutches were considered community ambulators. Non-parametric tests and logistic regression were used for analysis. RESULTS: A total of 115 patients with a MACE and 57 without a MACE were similar in gender (P = 0.99), ventriculoperitoneal status (P = 0.15) and age (16.0 vs 15.4 years, P = 0.11). Median ages at MACE procedure and follow-up were 7.0 and 8.2 years, respectively, and all used the MACE ≥3x/week. They were less likely to be ambulators (54.8 vs 71.9%, P = 0.03). In patients with a MACE, 64 (55.7%) had total fecal continence, compared with 29 (50.9%) without a MACE (P = 0.62). In the MACE group, ambulators were more likely to be continent compared with non-ambulatory patients (65.1 vs 44.2%, P = 0.04) (Table). Although not statistically significant, a similar difference was observed in the non-MACE group (56.1 vs 37.5%, P = 0.25). In the MACE group, continent and incontinent patients, regardless of ambulatory status, had similar rates of MACE use, additive use and time for MACE completion (P ≥ 0.43). MACE ambulators were more likely to be continent than MACE non-ambulators on multivariate analysis (OR 3.26, P = 0.01). DISCUSSION: This study reported higher than typical FI rates since: (1) it used a stringent definition of total fecal continence; (2) patients without FI were perhaps less likely to participate; and (3) it relied on patient-reported rather than clinician-reported outcomes. This cross-sectional study should not be interpreted as "MACE procedure is ineffective;" this would require a longitudinal study. The present findings may not apply to young children or those with significant developmental delay (patients excluded from the study). CONCLUSIONS: Ambulatory patients with SB are 50% more likely to have total fecal continence on long-term follow-up, particularly after a MACE procedure. Ambulatory status is a significant confounder of FI and should be considered in future analyses.