Sacral neuromodulation in children and adolescents with chronic constipation refractory to conservative treatment.

PURPOSE: Functional constipation in children and adolescents is a common and invalidating condition. In a minority of patients, symptoms persist despite optimal conservative therapy. The aim of this study was to evaluate whether the short-term effects of sacral neuromodulation (SNM) in children and adolescents with constipation are sustained over prolonged period of time. METHODS: Patients aged 10-20 years, with refractory constipation, fulfilling the Rome III criteria, were included in our study. If SNM test treatment showed >50 % improvement in defecation frequency, a permanent stimulator was implanted. Primary outcome measure was defecation frequency during 3 weeks. Secondary endpoints were abdominal pain and Wexner score. To assess sustainability of treatment effect, a survival analysis was performed. Cross-sectional quality of life was assessed using the EQ-5D VAS score. RESULTS: Thirty girls, mean age 16 (range 10-20), were included. The mean defecation frequency increased from 5.9 (SD 6.5) in 21 days at baseline to 17.4 (SD 11.6) after 3 weeks of test treatment (p < 0.001). During test treatment, abdominal pain and Wexner score decreased from 3.6 to 1.5 and 18.6 to 8.5 (p < 0.001), respectively. Improvement of symptoms sustained during a median follow-up of 22.1 months (12.2-36.8) in 42.9 % of patients. On a scale from 0 to 100, quality of life was 7 points lower than the norm score (mean 70 vs. 77). CONCLUSION: SNM is a therapeutic option for children with chronic constipation not responding to intensive oral and/or laxative therapy, providing benefits that appear to be sustained over prolonged period of time.

Baseline factors predictive of patient satisfaction with sacral neuromodulation for idiopathic fecal incontinence.

PURPOSE: Sacral neuromodulation (SNM) is an established treatment for fecal incontinence (FI). A recent study from our group found that the relationship between patient satisfaction and clinical outcome is complex and does not match the traditional used success criteria. Therefore, the ability to predict patient satisfaction must be given priority. The aim of the present study is to identify baseline factors predictive of patient satisfaction, with SNM, for idiopathic FI. METHODS: We analyzed data from patients treated with SNM for idiopathic FI in Aarhus, Denmark, and Maastricht, The Netherlands. A questionnaire considering self-reported satisfaction was mailed to these patients and compared to baseline characteristics. Logistic regression was used to determine the predictive value of baseline demographic and diagnostic variables. RESULTS: In total, 131 patients were included in the analysis. Patient satisfaction with the current treatment result was reported in 75 patients. Fifty-six patients were dissatisfied with SNM treatment, after median 46 months (range 11-122) with permanent implantation. Pudendal nerve terminal motor latency (PNTML) was the solely identified predictor for long-term patient satisfaction. A subgroup univariate-logistic regression analysis showed that PNTML ≤ 2.3 ms at the side of lead implantation was a statistically significant predictor for patient satisfaction (odds ratio (OR) 2.3, 95% confidence interval (CI) 1.01-5.24, p = 0.048). CONCLUSION: Baseline PNTML measurement may be predictive of long-term satisfaction with SNM therapy for idiopathic FI. Further studies are needed to confirm this result.

Sacral neuromodulation therapy: a promising treatment for adolescents with refractory functional constipation.

BACKGROUND: Sacral neuromodulation therapy has been successfully applied in adult patients with urinary and fecal incontinence and in adults with constipation not responding to intensive conservative treatment. No data, however, are available on sacral neuromodulation therapy as a treatment option in adolescents with refractory functional constipation. OBJECTIVES: This study aimed to describe the short-term results of sacral neuromodulation in adolescents with chronic functional constipation refractory to intensive conservative treatment. DESIGN: This is a retrospective review. SETTING: This study took place at the Department of Surgery, Maastricht University Medical Centre, The Netherlands. PATIENTS: Thirteen patients (all girls, age 10-18 years) with functional constipation according to the ROME III criteria not responding to intensive oral and rectal laxative treatment were assigned for sacral neuromodulation. MAIN OUTCOME MEASURES: When improvement of symptoms was observed during the testing phase, a permanent stimulator was implanted. Patients were prospectively followed up to at least 6 months after implantation of the permanent stimulator by interviews, bowel diaries, and Cleveland Clinic constipation score. Improvement was defined as spontaneous defecation ≥ 2 times a week. RESULTS: At presentation, none of the patients had spontaneous defecation or felt the urge to defecate. All patients had severe abdominal pain. Regular school absenteeism was present in 10 patients. After the testing phase, all but 2 patients had spontaneous defecation ≥ 2 times a week with a reduction in abdominal pain. After implantation, 11 (of 12) had a normal spontaneous defecation pattern of ≥ 2 times a week without medication, felt the urge to defecate, and perceived less abdominal pain without relapse of symptoms until 6 months after implantation. The average Cleveland Clinic constipation score decreased from 20.9 to 8.4. One lead revision and 2 pacemaker relocations were necessary. LIMITATIONS: This study is limited by its small sample size, single-institution bias, and retrospective nature. CONCLUSION: Sacral neuromodulation appears to be a promising new treatment option in adolescents with refractory functional constipation not responding to intensive conservative therapy. Larger randomized studies with long-term follow-up are required.

Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: a randomized controlled trial.

AIMS: Fecal incontinence (FI) is embarrassing, resulting in poor quality of life. Rectal sensation may be more important than sphincter strength to relieve symptoms. A single-blind, randomized controlled trial among adults with FI compared the effectiveness of rectal balloon training (RBT) and pelvic floor muscle training (PFMT) versus PFMT alone. METHODS: We randomized 80 patients, recruited from the Maastricht University Medical Centre. Primary outcome was based on the Vaizey score. Secondary outcomes were the Fecal Incontinence Quality of Life Scale (FIQL), 9-point global perceived effect (GPE) score, anorectal manometry, rectal distension volumes, and thresholds of anorectal sensation. Analyses were by intention-to-treat. RESULTS: Forty patients were assigned to combined RBT with PFMT and 40 to PFMT alone. Adding RBT did not result in a significant improvement in the Vaizey score [mean difference: -1.19; 95% confidence interval (CI): -3.79 to 1.42; P = 0.37]. Secondary outcomes favoring RBT were: Lifestyle subscale of the FIQL (0.37; 95% CI: 0.02-0.73; P = 0.04), GPE (-1.01; 95% CI: -1.75 to -0.27; P = 0.008), maximum tolerable volume (49.35; 95% CI: 13.26-85.44; P = 0.009), and external anal sphincter fatigue (0.65; 95% CI: 0.26-1.04; P = 0.001). Overall, 50% of patients were considered improved according to the estimated minimally important change (Vaizey change ≥-5). CONCLUSIONS: RBT with PFMT was equally effective as PFMT alone. Secondary outcomes show beneficial effects of RBT on urgency control, GPE, and lifestyle adaptations. Characteristics of patients who benefit most from RBT remain to be confirmed.

Patient experience and satisfaction with sacral neuromodulation: results of a single-center sample survey.

PURPOSE: Sacral neuromodulation is a well researched and successful treatment for functional bowel disorders. Indications have expanded throughout the years and various studies have been published on clinical efficacy or on technique improvement. The main goal of this retrospective study was to systematically evaluate daily experiences with this treatment and measure the long-term satisfaction of sacral neuromodulation therapy for functional bowel disorders. METHODS: After institutional review board approval a new, self-designed postal questionnaire was sent to all patients in our center who were being treated with sacral neuromodulation. Only patients with a minimal follow-up of 1 year were included in the survey. Implantation years range from 2000 to 2007. RESULTS: A total of 174 patients received the questionnaire regarding patient satisfaction and experience with sacral neuromodulation therapy. The response rate after reminder letter was 71.8% (n = 125) including 114 (91.2%) females. Patient satisfaction was high: 81 patients (65.3%) reported their results as very satisfying, 30 patients (24.2%) were moderately satisfied, and 13 patients (10.4%) were not satisfied. Analysis showed that patient satisfaction can be explained by both patient perception of present bowel function and their evaluation of the quality of daily life. No significant relationship was found with patient demographics, self-ascribed (co)morbidity, behavioral habits, or therapy duration. A total of 47 patients (38.2%) reported having some concerns regarding the future with sacral neuromodulation treatment. Twenty-eight patients (23.1%) reported a temporary loss of effect at any time during sacral neuromodulation therapy. Pain at the implantation site was reported by 65 patients (52.4%). CONCLUSIONS: This study shows that patients treated with sacral neuromodulation, in general, are very satisfied. The main problems mentioned by patients are pain, loss of efficacy, and general concerns.