Long-term outcome of sacral neuromodulation for chronic refractory constipation.

PURPOSE: Sacral neuromodulation has been reported as a treatment for severe idiopathic constipation. This study aimed to evaluate the long-term effects of sacral neuromodulation by following patients who participated in a prospective, open-label, multicentre study up to 5 years. METHODS: Patients were followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months. Symptoms and quality of life were assessed using bowel diary, the Cleveland Clinic constipation score and the Short Form-36 quality-of-life scale. RESULTS: Sixty-two patients (7 male, median age 40 years) underwent test stimulation, and 45 proceeded to permanent implantation. Twenty-seven patients exited the study (7 withdrawn consent, 7 loss of efficacy, 6 site-specific reasons, 4 withdrew other reasons, 2 lost to follow-up, 1 prior to follow-up). Eighteen patients (29%) attended 60-month follow-up. In 10 patients who submitted bowel diary, their improvement of symptoms was sustained: the number of defecations per week (4.1 ± 3.7 vs 8.1 ± 3.4, mean ± standard deviation, p < 0.001, baseline vs 60 months) and sensation of incomplete emptying (0.8 ± 0.3 vs 0.2 ± 0.1, p = 0.002). In 14 patients (23%) with Cleveland Clinic constipation score, improvement was sustained at 60 months [17.9 ± 4.4 (baseline) to 10.4 ± 4.1, p < 0.001]. Some 103 device-related adverse events were reported in 27 (61%). CONCLUSION: Benefit from sacral neuromodulation in the long-term was observed in a small minority of patients with intractable constipation. The results should be interpreted with caution given the high dropout and complication rate during the follow-up period.

Outcome of sacral nerve stimulation for fecal incontinence at 5 years.

OBJECTIVE: This study aimed to evaluate the outcome of sacral nerve stimulation (SNS) for fecal incontinence at 5 years after implantation and to identify predictors of sustained efficacy. BACKGROUND: There is a lack of knowledge about the long-term outcome of SNS for fecal incontinence. METHODS: Prospectively collected data from patients who underwent implantation of an SNS device between 2001 and 2006 were reviewed. RESULTS: One hundred and one patients were available for outcome evaluation at 5 years. Sixty of 101 patients [42.6% on intention-to-treat (ITT) and 55.6% per protocol (PP)] reported a favorable outcome, 41 patients (ITT 29.1%; PP 38.0%) reported an unfavorable outcome, of whom 24 patients (ITT 17.0%; PP 22.2%) had their device explanted or permanently switched off before 5 years. Wexner incontinence scores improved significantly from a baseline median of 16 (range 6-20) to a median of 6 (range 0-20) at 3 months (P < 0.0001), and the improvement compared with baseline was maintained throughout the 5-year follow-ups (P < 0.0001).Age was a negative predictive factor [odds ratio (OR): 0.96 each year increase, 95% confidence interval (CI): 0.92-0.99; P = 0.016]. Positive predictors included improvement of urge incontinence episodes during percutaneous nerve evaluation (OR: 10.8; 95% CI: 1.72-132; P = 0.036), improvement of incontinence scores at 6 months from baseline (OR: 6.29; 95% CI: 1.33-34.3; P = 0.025), particularly improvement of incontinence scores from 3 to 6 months (OR: 41.5; 95% CI: 3.51-811; P = 0.007). Overall, 521 reportable events were recorded from 94 patients (93.1%). CONCLUSIONS: On an ITT analysis, 42.6% of patients reported favorable outcomes at 60 months. Patient's age, improvement of urge incontinence during PNE, and sustained efficacy during the first 6 months after implantation are some of the predictors identified.

Medium-term outcome of sacral nerve modulation for constipation.

BACKGROUND: Sacral nerve modulation has been reported as a minimally invasive and effective treatment for constipation refractory to conservative treatment. OBJECTIVE: This study aimed to evaluate the efficacy and sustainability of sacral nerve modulation for constipation in the medium term (up to 6 years) and to investigate potential predictors of treatment success. DESIGN: We performed a retrospective review of prospectively collected data. SETTINGS: The study was performed at 2 tertiary-care centers in Europe with expertise in pelvic floor disorders and sacral nerve modulation. PATIENTS: Patients were eligible if they had had symptoms of constipation persisting for at least 1 year, if conservative treatment (dietary modification, laxatives and biofeedback therapy) had failed, and if predefined excluded conditions were not present. INTERVENTION: The first phase of the treatment process was percutaneous nerve evaluation. If this was successful, patients underwent sacral nerve modulation therapy with an implanted device (tined-lead and implantable pulse generator). MAIN OUTCOME MEASURE: Follow-up was performed at 1, 3, 6, and 12 months, and yearly thereafter. Outcome was assessed with the Wexner constipation score. RESULTS: A total of 117 patients (13 men, 104 women) with a mean age of 45.6 (SD, 13.0) years underwent percutaneous nerve evaluation. Of these, 68 patients (58%) had successful percutaneous nerve evaluation and underwent implantation of a device. The mean Wexner score was 17.0 (SD, 3.8) at baseline and 10.2 (SD 5.3) after percutaneous nerve evaluation (p < .001); the improvement was maintained throughout the follow-up period, although the number of patients continuing with sacral nerve modulation at the latest follow-up (median, 37 months; range, 4-92) was only 61 (52% of all patients who underwent percutaneous nerve evaluation). The sole predictive factor of outcome of percutaneous nerve evaluation was age: younger patients were more likely than older patients to have a successful percutaneous nerve evaluation phase. LIMITATIONS: The study was limited by a lack of consistent outcome measures. CONCLUSIONS: : Despite improvement in Wexner scores, at the latest follow-up sacral nerve modulation was only being used by slightly more than 50% of the patients who started the first phase of treatment. Further studies are needed to reassess the efficacy and sustainability of sacral nerve modulation.

Postoperative issues of sacral nerve stimulation for fecal incontinence and constipation: a systematic literature review and treatment guideline.

BACKGROUND: There is a lack of knowledge on the incidence and management of suboptimal therapeutic effect and the complications associated with sacral nerve stimulation for fecal incontinence and constipation. OBJECTIVE: This study aimed to review current literature on postoperative issues and to propose a treatment algorithm. DATA SOURCE: PubMed, MEDLINE, and EMBASE were searched using the keywords "sacral nerve stimulation," "sacral neuromodulation," "fecal incontinence," and "constipation" for English-language articles published from January 1980 to August 2010. A further search was conducted on a wider literature using the keywords "complication," "adverse effect," "treatment failure," "equipment failure," "infection," "foreign-body migration," "reoperation," "pain," and "algorithm." STUDY SELECTION: Four hundred sixty-one titles were identified, and after a title and abstract review, 135 were subjected to full article review; 89 were finally included in this review. Five articles were added by manual search and consensus. RESULTS: Forty-eight studies were identified as cohort studies reporting on postoperative issues, including 1661 patients who underwent percutaneous nerve evaluation and 1600 patients who proceeded to sacral nerve stimulation therapy. Pooled data showed that the most common problem during percutaneous nerve evaluation was lead displacement (5.3%). The incidence of suboptimal outcome, pain, and infection after implantation was 12.1%, 13.0%, and 3.9%. LIMITATIONS: There was significant underreporting of untoward events, because 60% of the studies did not report complications during percutaneous nerve evaluation, and suboptimal outcome after implantation was not disclosed in 44% of the studies. CONCLUSIONS: The incidence of untoward events associated with sacral nerve stimulation appears to be low. However, there is a significant underreporting of the incidence. Using the information from the structured and systematic literature review, we formulated a clinically relevant guideline for reporting and managing postoperative issues. The guideline can provide a framework for clinical practice.

Temporary sacral nerve stimulation for faecal incontinence following pelvic radiotherapy.

Temporary sacral nerve stimulation for faecal incontinence caused by pelvic radiation injuries was successful in 7 of 13 patients (54%). The improvement of total incontinence episodes during the temporary stimulation period was a median of 83% (range 25-93%). This may be a viable treatment option for radiation-induced faecal incontinence.

Sacral nerve stimulation for constipation: suboptimal outcome and adverse events.

PURPOSE: Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events. METHODS: A retrospective review was performed on patients who underwent sacral nerve stimulation for constipation between August 2002 and September 2008. Collected data included patients' demographic data, type and management of suboptimal outcomes and complications, and stimulation parameters at the time of reportable events. RESULTS: Thirty-eight patients (32 women; mean age, 45.6 y; SD, 11.8; range, 21-66) received a permanent stimulator after a successful test period. The mean treatment duration was 25.7 months (SD, 20.4; range, 0-70). Twenty-two patients (58%) experienced at least one reportable event attributable to the treatment. The total of 58 reportable events were noted, including lack or loss of efficacy, pain, and undesired change of sensation. Reprogramming successfully managed 28 reportable events (48%), 19 events (33%) required surgical interventions, and 3 adverse events led to discontinuation of the treatment. CONCLUSIONS: Nearly 60% of patients who received sacral nerve stimulation for constipation experienced at least one reportable event. Although the events were often resolved by reprogramming, more than one-third required surgical intervention or discontinuation of therapy. Patients undergoing sacral nerve stimulation for constipation need to be informed of these possibilities. A systematic assessment is needed to identify the cause and optimize the management of reportable events.

Retention test in sacral nerve stimulation for fecal incontinence.

INTRODUCTION: Sacral nerve stimulation has become an established treatment for patients with fecal incontinence. However, the mechanism of its action remains obscure. We aim to assess whether sacral nerve stimulation improves patients' ability to retain rectal content. METHODS: Patients who had been treated successfully with sacral nerve stimulation underwent four retention tests during which the stimulator was turned either on or off. Both the patients and investigators were blinded to the status of the stimulator. The retention test results were assessed for interassessment agreement and for any differences between the on and off phases. Wexner scores, anorectal physiology tests, and patients' perceptions of stimulator settings were also recorded. RESULTS: Nineteen patients (16 women; mean age, 57.5 years) took part in the study. Retention tests showed moderate interassessment agreement (weighted Cohen's kappa index, 0.45). There were no sharp differences in retained volume between the stimulator's on and off phases (median 50 (range, 0-300) mL vs. 50 (range, 0-300) mL; P = 0.85). CONCLUSION: Sacral nerve stimulation does not alter patients' ability to retain rectal content. Further studies are needed to investigate the mechanism of sacral nerve stimulation.

Does the St. Mark's incontinence score reflect patients' perceptions? A review of 390 patients.

PURPOSE: The St. Mark's incontinence score is widely used to evaluate the severity of fecal incontinence. It is unknown to what extent such scores relate to patients' perceptions about their condition. The primary goal of this study was to assess this correlation. Secondary goals were to evaluate the relationship between different types of incontinence, age, gender, and the continence score and to assess the sensitivity of St. Mark's incontinence score to a change in patients' perception and outcome evaluation after treatment. METHODS: Patients' subjective perception of bowel control (using a 0-10 scale) and St. Mark's incontinence score for 390 patients were reviewed. Change in the score was documented for 131 patients who underwent biofeedback treatment and compared with patients' outcome evaluation. RESULTS: There was a moderate correlation between patients' perception of bowel control and the St. Mark's incontinence score (r = -0.55; P < 0.001). The correlation was maintained, regardless of type of incontinence (r = -0.48 to -0.55), age (60 years: r = -0.58; P < 0.001) or gender (male: r = -0.48; female: r = -0.53; P < 0.001) of patients. St. Mark's incontinence score was sensitive to a change in patients' subjective evaluation after the treatment. CONCLUSIONS: The St. Mark's incontinence score correlates moderately well with patients' subjective perception and is reliable regardless of the type of incontinence, patients' age, or gender. It is suitable for the severity assessment of fecal incontinence and the evaluation of a treatment outcome.