Title: Prospective Evaluation of Sacral Nerve Modulation in Children with Validated Questionnaires
Purpose: Sacral neuromodulation for refractory urinary dysfunction has been well described in the adult population and its use in the pediatric population has recently gained popularity. Most of these studies, however, have either been retrospective or have not used validated questionnaires to assess bowel and bladder dysfunction (BBD), as well as quality of life (QOL). We hypothesized that pediatric patients undergoing sacral neuromodulation with InterStim¨ will see a significant improvement in QOL as well as bowel and bladder dysfunction. We prospectively evaluated all patients before and after undergoing sacral neuromodulation using validated QOL and BBD questionnaires.
Methods: All pediatric patients scheduled for sacral neuromodulation were eligible to participate. All patients underwent video urodynamics and indications for surgery included patients with refractory voiding symptoms that had failed both behavioral and medical therapy. Patients were enrolled and consented prospectively and completed the age-appropriate, validated PedsQL TM 4.0 Generic Core Scales and University of British Columbia dysfunctional elimination questionnaire. The QOL questionnaire consisted of 23 items comprising 4 dimensions: physical, emotional, social, and school functioning. Scores were reported as Physical Health Summary (physical functioning), Psychosocial Health Summary (emotional, social and school functioning) and total QOL. Scores ranged from 0-100 (higher scores indicating higher QOL). The BBD questionnaire consists of 14 total questions with a score ranging from 0-52, with >11 indicating dysfunction. Total questionnaire scores were compared between the two groups using the Wilcoxon matched-pairs test. A p-value < .05 was considered statistically significant.
Results: A total of 10 patients (2 males, 8 females) were enrolled in the study from July, 2011-April, 2012 with a median age of 9.5 years. All patients underwent second stage placement of the generator. One child developed an infection and had the device removed but replaced months later. The mean pre-op physical QOL was 88.13 ± 13.7 compared to post-op 89.7 ± 9.9 (p=.87). Psychosocial QOL pre- and post-op was 73.5 ± 18.8 and 83.95 ± 15.1, respectively (p=.08). Total QOL pre and post-op was 78.6 ± 15.2 and 86.2 ± 11.9, respectively (p=.08). Mean pre and post-op BBD scores were 23.4 ± 8.7 and 10.3 ± 6.9, respectively (p=.006). Figure 1 shows individual patients and BBD dysfunction.
Conclusion: Patients undergoing sacral neuromodulation for refractory urinary dysfunction had a significant improvement in BBD scores, however there was no significant difference in QOL before and after surgery. Patients with long-standing urinary dysfunction had a higher than expected QOL prior to implantation. Continuing to follow these patients in a prospective manner with validated questionnaires will strengthen the current evidence in support of sacral neuromodulation in the pediatric population.