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.

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.

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.

Sacral neuromodulation for the treatment of chronic functional anorectal pain: a single center experience.

INTRODUCTION: Treatment of functional anorectal pain disorders remains a challenge. The purpose of this study is to describe a single center experience with sacral neuromodulation for the treatment of chronic functional anorectal pain. METHODS: This is a retrospective study based on prospectively collected data of patients treated with sacral neuromodulation for functional anorectal pain from April 2005 to August 2008. Symptoms were analyzed using a visual analog scale pain score (0 to 10). A 7-point Likert scale was used to rate global perceived effect. All patients had a percutaneous nerve evaluation and subsequent test stimulation to assess sacral neuromodulation outcome prior to permanent implantation. Patients were eligible for permanent sacral neuromodulation in case of a pain score <3 during test stimulation and/or >50% decrease in the pain score compared to baseline. RESULTS: Nine patients (2 males) were included in this study. Mean age was 53.8 years (27.6 to 74.0). Four patients (1 male) had successful test stimulation and were eligible for permanent implantation. Median pain score decreased from 8.0 (6.0 to 9.0) to 1.0 (0 to 2.0). All patients experienced a lasting improvement during the follow-up till 24 months. Global perceived effect in successful patient was 1 (completely recovered) in one patient and 2 (much improved) in three patients. CONCLUSION: This study showed that sacral neuromodulation can be a successful treatment for functional anorectal pain not responding to other treatments. Improvement obtained during test stimulation is a good predictor (diagnostic) for sustained success of permanent sacral neuromodulation.

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study.

BACKGROUND: Fecal incontinence (FI) is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem which affects about 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to this treatment regime. Two physiotherapy interventions, rectal balloon training (RBT) and pelvic floor muscle training (PFMT) are widely used in the management of FI. However, their effectiveness remains uncertain since well-designed trials on the effectiveness of RBT and PFMT versus PFMT alone in FI have never been published. METHODS/DESIGN: A two-armed randomized controlled clinical trial will be conducted. One hundred and six patients are randomized to receive either PFMT combined with RBT or PFMT alone. Physicians in the University Hospital Maastricht include eligible participants. Inclusion criteria are (1) adults (aged > or = 18 years), (2) with fecal incontinence complaints due to different etiologies persisting for at least six months, (3) having a Vaizey incontinence score of at least 12, (4) and failure of conservative treatment (including dietary adaptations and pharmacological agents). Baseline measurements consist of the Vaizey incontinence score, medical history, physical examination, medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, anal endosonography, defecography, symptom diary, Fecal Incontinence Quality of Life scale (FIQL) and the PREFAB-score. Follow-up measurements are scheduled at three, six and 12 months after inclusion. Skilled and registered physiotherapists experienced in women's health perform physiotherapy treatment. Twelve sessions are administered during three months according to a standardized protocol. DISCUSSION: This section discusses the decision to publish a trial protocol, the actions taken to minimize bias and confounding in the design, explains the choice for two treatment groups, discusses the secondary goals of this study and indicates the impact of this trial on clinical practice. TRIAL REGISTRATION: The Netherlands Trial Register ISRCTN78640169.

Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study.

PURPOSE: A proportion of patients have fecal incontinence secondary to a full-thickness rectal prolapse that fails to resolve following prolapse repair. This multicenter, prospective study assessed the use of sacral nerve stimulation for this indication. METHODS: Patients had to have more than or equal to four days with fecal incontinence per 21-day period more than one year after surgery. They had to have failed conservative treatment and have an intact external anal sphincter. RESULTS: Four female patients aged 42, 54, 68, and 65 years met the inclusion criteria. Three of the four patients had had more than one operation for recurrent full-thickness rectal prolapse before sacral nerve stimulation, one of whom had undergone a further operation for recurrence following stimulation. One patient had undergone one operation for prolapse repair. The preoperative duration of symptoms was ten, eight, three, and nine years, respectively. Although patients had an intact external anal sphincter, one patient had a fragmented internal anal sphincter. The frequency of fecal incontinent episodes changed from 11, 24.7, 5, and 8 per week at baseline to 0, 1.5, 5.5, and 1 per week at latest follow-up. Ability to defer defecation was also improved in two of three patients who had this documented. Fecal incontinence-specific quality of life assessment showed an improvement in all four domains. CONCLUSION: Sacral nerve stimulation should be considered for patients with ongoing fecal incontinence following full-thickness rectal prolapse repair if they prove resistant to conservative treatment.

Sacral neuromodulation in patients with fecal incontinence: a single-center study.

PURPOSE: Fecal incontinence is a psychologically devastating and socially incapacitating condition. Conventional treatment is likely to improve continence in many patients; however, there remains a group with persisting symptoms who are not amenable for a simple surgical repair. We evaluated the effect of sacral neuromodulation in patients with structurally intact sphincters after failure of conventional treatment. METHODS: Patients aged 18 to 75 years were evaluated. Incontinence was defined as involuntary loss of stool at least once per week, which was objectified by completion of a three-week bowel-habits diary during ambulatory electrode stimulation at the S3 or S4 foramen. Patients were qualified for permanent stimulation when showing a reduction of at least 50 percent in incontinence episodes or days. RESULTS: Seventy-five patients (66 females; mean age, 52 (range, 26-75) years) were treated. Three patients had partial spinal cord injury, two patients a previous low-anterior resection, and nine patients had a previous sphincter repair. Evaluation after trial screening showed that 62 patients (83 percent) had improved continence. Median incontinence episodes per week decreased from 7.5 to 0.67 (P < 0.01), median incontinence days per week from 4 to 0.5 (P < 0.01). The symptomatic response stayed unchanged after implantation of a permanent electrode and pacemaker in 50 patients. After a median follow-up of 12 months, this effect could be sustained in 48 patients. Anal manometry during stimulation showed no increase of sphincter pressures. CONCLUSIONS: Sacral neuromodulation is a feasible treatment option for fecal incontinence in patients with structurally intact sphincters.

Long-term follow-up of dynamic graciloplasty for fecal incontinence.

PURPOSE: Graciloplasty has been used as a treatment for end-stage fecal incontinence since 1946. Electric stimulation with an implantable pulse generator has existed for 15 years. The gracilis muscle is wrapped around the anal canal and stimulated by intramuscular electrodes connected with an implantable pulse generator. Initial reports have been promising, but long-term results have not been presented to date. METHODS: Data of 200 consecutive patients with a follow-up of at least two years were analyzed in a prospective manner from 1986 until 1999. RESULTS: The overall success rate was 72 percent. In patients with fecal incontinence caused by trauma, the rate was 82 percent. Once continent, patients remained continent after a median follow-up of 261 (standard deviation, 132) weeks. Median survival of the implantable pulse generator until battery expiration was 405 weeks. Disturbed evacuation remained a problem in 16 percent of all patients. Complications were frequent but treatable. CONCLUSION: Dynamic graciloplasty is a good, cost-effective treatment for fecal incontinence with results lasting for a median of more than five years.

Effect of dietary inulin supplementation on inflammation of pouch mucosa in patients with an ileal pouch-anal anastomosis.

PURPOSE: Inflammation is a constant finding in the ileal reservoir of patients with an ileal pouch-anal anastomosis and is associated with decreased fecal concentrations of the short chain fatty acid butyrate, increased fecal pH, changes in fecal flora, and increased concentrations of secondary bile acids. In healthy subjects, inulin, a dietary fiber, is fermented to short chain fatty acids and leads to a lower pH and potentially beneficial changes in fecal flora. The aim of the present study was to investigate the effect of enteral supplementation of inulin on inflammation of the ileal reservoir. METHODS: Twenty patients received 24 g of inulin or placebo daily during three weeks in a randomized, double-blind, crossover design. Stools were analyzed after each test period for pH, short chain fatty acids, microflora, and bile acids. Inflammation was assessed endoscopically, histologically, and clinically. RESULTS: Compared with placebo, three weeks of dietary supplementation with 24 g of inulin increased butyrate concentrations, lowered pH, decreased numbers of Bacteroides fragilis, and diminished concentrations of secondary bile acids in feces. This was endoscopically and histologically accompanied by a reduction of inflammation of the mucosa of the ileal reservoir. CONCLUSION: Enteral inulin supplementation leads to a decrease of inflammation-associated factors and to a reduction of inflammation of pouch mucosa.