Cost-effectiveness of sacral neuromodulation for chronic refractory constipation in children and adolescents: a Markov model analysis.

AIM: This study aimed to assess the cost-effectiveness of sacral neuromodulation (SNM) compared with conservative treatment in children and adolescents with constipation refractory to conservative management. METHOD: A Markov probabilistic model was used, comparing costs and effectiveness of SNM and conservative treatment in children and adolescents aged 10-18 years with constipation refractory to conservative management. Input for the model regarding transition probabilities, utilities and healthcare costs was based on data from a cohort of patients treated in our centre. This cohort consisted of 30 female patients (mean age 16 years) with functional constipation refractory to conservative management. The mean duration of laxative use in this group was 5.9 years. All patients had a test SNM, followed by a permanent SNM in 27/30. Median follow-up was 22.1 months (range 12.2-36.8). The model was run to simulate a follow-up period of 3 years. RESULTS: The mean cumulative costs for the SNM group and the conservative treatment group were €17 789 (SD €2492) and €7574 (SD €4332) per patient, respectively. The mean quality adjusted life years (QALYs) in the SNM group was 1.74 (SD 0.19), compared with 0.86 (SD 0.14) in the conservatively managed group. The mean incremental cost-effectiveness ratio was €12 328 per QALY (SD €4788). Sensitivity analysis showed that the outcomes were robust to a wide range of model assumptions. CONCLUSION: Chronic constipation seriously affects the quality of life of children and adolescents. Preliminary evidence suggests that SNM can improve symptoms and quality of life at a reasonable cost.

Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence.

BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS: Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).

Cost-effectiveness analysis of sacral neuromodulation for faecal incontinence in The Netherlands.

AIM: Sacral neuromodulation (SNM) plays a major part in the algorithm of management of faecal incontinence, but there are limited data on its cost-effectiveness. This study aimed to analyse this and the quality-adjusted life-years (QALYs) associated with two different treatment algorithms. The first (SNM-) included use of an artificial sphincter [dynamic graciloplasty (DGP) (50%) and artificial bowel sphincter (ABS) (50%)]. The second (SNM+) included SNM (80% of cases) and artificial sphincter (DGP 10%; ABS 10%) The incidence of sphincteroplasty was assumed to be equal in both algorithms. METHOD: A Markov model was developed. A hypothetical cohort of patients was run through both strategies of the model. A mailed EuroQoL-5D questionnaire was used to determine health-related quality of life. Costs were reproduced from the Maastricht University Medical Centre prospective faecal incontinence database. The time scale of the analysis was 5 years. RESULTS: The former treatment protocol cost €22,651 per patient and the latter, after the introduction of SNM, cost €16,473 per patient. The former treatment protocol resulted in a success rate of 0.59 after 5 years, whereas with the introduction of SNM this was 0.82. Adhering to the former treatment protocol yielded 4.14 QALYs and implementing the latter produced 4.21 QALYs. CONCLUSION: The study demonstrated that introducing SNM in the surgical management algorithm for faecal incontinence was both more effective and less costly than DGP or ABS without SNM. This justifies adequate funding for SNM for patients with faecal incontinence.

Sexual response in patients treated with sacral neuromodulation for lower urinary tract symptoms or fecal incontinence.

OBJECTIVES: To determine whether sacral neuromodulation (SNM) for urinary symptoms or fecal incontinence gives improvement of female sexual function and whether improvement is due to physiological or psychological factors. METHODS: Between 2002 and 2008, 8 patients had an array of questionnaires before and after SNM implantation. The questionnaires were: the Questionnaire for Screening for Sexual Dysfunctions, the Golombok Rust Inventory of Sexual Satisfaction, the Symptom Checklist-90, the Maudsley Marital Questionnaire and the McGill-Mah Orgasm Questionnaire. Three of these 8 patients underwent vaginal plethysmography before and after implantation. RESULTS: No statistically significant changes were found, although there seems to be a trend toward improvement in orgasm scores. In plethysmography all 3 patients showed increased vaginal pulse amplitude with the stimulator turned on with both erotic and non-erotic stimuli. CONCLUSIONS: This study does not show a clear effect of SNM on sexual function, although there seems to be an improvement in orgasm scores. The lack of response on psychological questionnaires and the increase in vaginal pulse amplitude after SNM implantation indicate that there might be a physiological response.

Sacral nerve modulation for defaecation and micturition disorders in patients with spina bifida.

AIM: Sacral nerve modulation is a well accepted method for the treatment of defaecation disorders and voiding dysfunction. Results of sacral nerve modulation in patients with spinal cord lesions are not well assessed, but preliminary results look poor. Therefore, the purpose of this study was to assess the effectiveness of sacral nerve modulation for defaecation disorders and voiding dysfunction in patients with spina bifida. METHOD: Consecutive patients with spina bifida suffering from a myelomeningocele and combined faecal and urinary functional disorders that were eligible for peripheral nerve evaluation (PNE) were studied. A permanent sacral nerve modulation implantation was performed after successful PNE. RESULTS: Ten patients (four female) were included in this study with a median age of 26.4 (range 11.1-41.0) years. In two the PNE was not possible. The median faecal incontinence days (6.0 vs 3.5) and episodes (8.5 vs 3.5) per 21 days decreased significantly during the 3-week period of PNE (P = 0.033). Only 3/10 (30%) patients had a more than 50% improvement and proceeded to a permanent sacral nerve modulation implantation. In one patient it was not possible to perform the permanent implant. CONCLUSION: Preliminary results of sacral nerve modulation in a subgroup of spina bifida patients with combined faecal and urinary functional disorders look promising, but long-term results in larger patient groups need to be studied.

Conservative treatment of patients with faecal soiling.

PURPOSE: A prospective evaluation of fifty patients with faecal soiling but normal sphincter function treated by a conservative treatment algorithm. PATIENTS AND METHODS: Between January 2010 and January 2011, 50 consecutive patients of two different clinical centres, with faecal soiling and normal anorectal function as assessed by endoanal ultrasound, MRI and anal manometry, were eligible for the purpose of this study. All patients started the therapy by psyllium (PS) and a fibre-rich diet daily after 2 months followed by rectal irrigation (RI) in case of incomplete response and after 4 months by 4 g colestyramine (CO), respectively. The patients completed the Vaizey incontinence score and a 2-week diary card. All tests were performed repeated after 2, 4 and 8 months, respectively. RESULTS: The study group consisted of 41 men and 9 women and a mean age of 38 years (21-70). The soiling complaints resolved completely in 37 (79%) patients. After treatment with PS, RI and CO, 12 (24%) patients, 24 (73%) patients and 1 (79%) patient, respectively, resolved completely of faecal soiling. Average weekly soiling frequency, the amount of patients wearing pads daily and the Vaizey incontinence score diminished significantly after treatment with psyllium and after treatment with rectal irrigation (P < 0.001). CONCLUSION: Conservative treatment focussed on complete evacuation or clearing the anorectal canal is effective in the treatment of patients with faecal soiling.

Neuromodulation for constipation: sacral and transcutaneous stimulation.

Constipation is a frequently occurring digestive ailment that is usually treated conservatively. Neuromodulation is altering function of an organ by altering neural activity. This paper reviews methods of neuromodulation used to treat constipation. This includes direct stimulation of sacral nerves and stimulation across the skin. Direct stimulation of sacral nerves is the most well developed method and is presented in detail. It is generally accepted that the mechanism of action is modulation rather than stimulation so it is called sacral neuromodulation (SNM). SNM involves percutaneous placement of an electrode in the third sacral foramen and implanting a stimulating device under the skin in the buttocks. SNM is founded on the physiological principle that activity in one neural pathway modulates pre-existing activity in another through synaptic interaction. The mechanism of action in constipation may be neuromodulation of the extrinsic neural control of the large bowel or modulation of reflexes inhibiting large bowel function. Limited evidence is available to assess the outcome of SNM in constipation. Results in the medium term seem promising for selected patients with idiopathic slow and normal transit constipation not responding to optimal conservative treatment. Adverse events include electrode migration and infection. The availability of a testing phase provides a predictor of treatment outcome. In addition, transcutaneous stimulation using sticky pad electrodes over the lumbosacral region or acupuncture points has been reported to improve constipation symptoms. In general, the level of evidence is low and further studies are needed.

Status of sacral neuromodulation for refractory constipation.

AIM: This review article aims to provide a brief update on the current data on and position of sacral neuromodulation (SNM) in the specialized management of refractory idiopathic constipation. METHOD: Published evidence from PubMed and our own unpublished data on SNM treatment for refractory idiopathic constipation were used for this evaluation. RESULTS: Seven studies were found in PubMed that covered this topic. The main focus was on the most recently published multicentre nonrandomized European trial. Summary data from our unpublished study on constipation in children are also included. CONCLUSIONS: The use of SNM in the treatment of idiopathic constipation is still in its early phase and while the available efficacy and safety data are limited, they show promising results. As there are few alternatives for this difficult patient group, it is worth offering a percutaneous nerve evaluation (PNE) test, which is known to be a good predictor of postimplant treatment success.

Sacral neuromodulation: long-term outcome and quality of life in patients with faecal incontinence.

AIM: Since 1994 sacral neuromodulation (SNM) has increasingly been used for the treatment of faecal incontinence, but no long-term data in a large group of patients have so far been published. We report long-term outcome and quality of life in the first 50 patients treated by permanent SNM for faecal incontinence. METHOD: We began to use SNM in 2000. Data from the first 50 patients with faecal incontinence who underwent permanent SNM are presented. Efficacy was assessed using a bowel diary and the Quality of Life score was assessed by the Faecal Incontinence Quality of Life questionnaire (FIQOL) and the standard short form health survey questionnaire (SF-36). RESULTS: Over a median follow up of 7.1 (5.6-8.7) years, forty-two (84%) patients had an improvement in continence of over 50%. Median incontinent episodes and days of incontinence per week decreased significantly during follow up (P<0.002). Improvement was seen in all four categories of the FIQOL scale and in some domains of the SF-36 QOL questionnaire. There were no statistically significant changes in the median resting and squeeze anal canal pressures. CONCLUSION: Initial improvement in continence with SNM was sustained in the majority of patients, with an overall success rate of 80% after a permanent implant at 7 years.

The role of reprogramming in sacral nerve modulation for faecal incontinence.

AIM: After implantation of a sacral nerve modulation (SNM) device for faecal incontinence (FI), patients are subjected to a rigid follow-up schedule. If symptoms recur, it may be necessary to reprogramme the stimulation parameters of the device. The aims of this study was to assess the need for reprogramming in patients with an SNM implant for FI. METHOD: All patients who received a permanent SNM implant for FI from January 2000 to February 2008 were included in this study. Patients were subjected to a rigid follow-up schedule at 1, 3, 6 and 12 months, and yearly thereafter. Stimulator settings of the SNM device and changes made at every visit were collected and added to the database, and the number of patients in whom the stimulation parameter settings needed reprogramming was determined. RESULTS: A total of 155 patients (11 men) were analysed. The mean age (± standard deviation) of the patients was 57.7 ± 11.9 years. Median follow-up was 28.1 (range: 1.0-93.6) months. The mean voltage increased significantly from 1.8 V at 1 month to 2.0 V at 3 months. Thirty-nine (25.2%) patients required no reprogramming of their SNM implant during any of their follow-up visits; however, 51 (32.9%) patients required reprogramming at 1-25% of their visits, 42 (27.1%) patients at 26-50% of their visits, 14 (9.0%) patients at 51-75% of their visits and nine (5.8%) patients at 76-100% of their visits. CONCLUSION: Physicians and patients need to be aware of the fact that reprogramming of the SNM stimulator needs to be carried out at least once during follow-up in the majority of patients. Trained physicians or specialist nurses are imperative to ensure effective follow-up and appropriate SNM reprogramming.

Sacral neuromodulation: does it affect the rectoanal angle in patients with fecal incontinence?

BACKGROUND: In the past decade numerous studies have been published on the successful treatment of fecal incontinence with sacral neuromodulation (SNM). The underlying mechanism of action for lower bowel motility disorders has been unclear. In the present study, the effect of SNM on the rectoanal angle in patients with fecal incontinence was investigated. PATIENTS AND METHODS: In 12 consecutive patients who qualified for SNM an X-defecography study was performed before SNM and at 6 months after permanent implant. Three single lateral rectal views were taken: one during rest, one during squeeze, and one during Valsalva's maneuver, after which the patient was asked to evacuate as rapidly and completely as possible during lateral fluoroscopy. At 6 months two further defecography studies were performed, one during stimulation with the pacemaker on and one with the pacemaker off. RESULTS: The defecography studies showed that the rectoanal angle decreased during rest, squeeze, and Valsalva's maneuver. A slight increase in rectoanal angle was seen during defecation. However, the differences did not reach statistical significance. Sacral neuromodulation improved fecal continence significantly in all patients at 6 months. Median incontinence episodes per week decreased from 6.2 to 1.0 (P = 0.001), and incontinent days per week decreased from 3.7 to 1.0 (P = 0.001) with SNM. There were no significant changes in the median resting and squeeze anal canal pressures, 46.5 versus 49.7 mmHg and 67.1 versus 72.3 mmHg, respectively. Median stimulation amplitude at follow-up was 2.7 V (range: 0.9-5.3 V). CONCLUSIONS: Rectoanal angle did not decrease significantly in patients with fecal incontinence during SNM.

A prospective multicentre study to investigate percutaneous tibial nerve stimulation for the treatment of faecal incontinence.

AIM: Percutaneous tibial nerve stimulation (PTNS) is a minimal invasive treatment that can be performed in the outpatient clinic. This is a pilot study to investigate PTNS in the treatment of faecal incontinence. METHOD: Percutaneous tibial nerve stimulation was performed by insertion of a needle electrode near the posterior tibial nerve. Patients were treated twice a week. Evaluation of faecal incontinence and quality of life was performed at baseline, 6 weeks, 3 months, 6 months and 1 year. Quality of life was estimated using SF-36 and FIQL questionnaires. RESULTS: A total of 22 patients were included. The mean age was 60.4 ± 11.7 years. After 6 weeks, 18 continued the treatment; 13 patients had a > 50% decrease in incontinence episodes. Overall incontinence episodes fell from 19.6 ± 21.0 at baseline to 9.9 ± 15.5 (P = 0.082) at 6 weeks and to 3.6 ± 4.8 (P = 0.029) at 1 year. Postponement time and quality of life increased significantly during follow up. CONCLUSION: Percutaneous tibial nerve stimulation is simple and can be used in the outpatient setting. Good results can be obtained and sustained during maintenance treatment.

Sacral nerve modulation and other treatments in patients with faecal incontinence after unsuccessful pelvic floor rehabilitation: a prospective study.

OBJECTIVES: Sacral nerve modulation (SNM) is a minimally invasive technique for the treatment of faecal incontinence. This study investigates the results of SNM after negative outcome of a standardized pelvic floor rehabilitation (PFR) programme for the treatment of faecal incontinence. METHOD: A prospective cohort study was performed between December 2001 and August 2007. Consecutive patients who visited the outpatient department for faecal incontinence were included in a multicentre study and treated with standardized PFR. Those with an unsuccessful result who were eligible for SNM were included in the present study. Failures at test stimulation or SNM received another treatment. Clinical outcome, Vaizey scores and Hirschsprung's disease/anorectal malformation quality-of-life (EQ-5D and HAQL) were assessed during follow-up in patients with SNM and in patients with other treatments (OT). Adverse events (AE) were documented. RESULTS: Thirty-five patients (mean age 59.7 years; 31 females) were included. Twenty-one had a successful test stimulation and 19 patients proceeded to a SNM implant. Incontinence episodes per week decreased significantly from 11.1 +/- 11.7 to 1.9 +/- 2.6 during test stimulation (P < 0.0001) and SNM over 24.1 months follow-up. The overall success rate was 49% (17/35). The patients with unsuccessful test stimulation or SNM received OT. The Vaizey score improved in both SNM (18.2 +/- 3.5 vs 13.7 +/- 4.8; P = 0.004) and other treatment (18.2 +/- 3.5 vs 13.9 +/- 6.9; P = 0.019). The HAQL scale improved significantly during SNM in all subscales (P < 0.005), but not in the other treatment group. Eight AE occurred during test stimulation (23%) and six AE after permanent implantation (26%). CONCLUSION: Sacral nerve modulation improves disease specific quality of life significantly compared with other treatment.

Factors associated with percutaneous nerve evaluation and permanent sacral nerve modulation outcome in patients with fecal incontinence.

PURPOSE: Sacral nerve modulation is an established treatment for fecal incontinence. Little is known about predictive factors for successful percutaneous nerve evaluation (or test stimulation) and permanent sacral nerve modulation outcome. The purpose of this retrospective study was to discover predictive factors associated with temporary and permanent stimulation. METHODS: We analyzed data from test stimulations performed in patients with fecal incontinence from March 2000 until May 2007. Successful outcome was defined as >50% improvement of incontinence episodes in three weeks. Patients with a successful test stimulation were eligible for permanent sacral nerve modulation implantation. All patients who subsequently had permanent sacral nerve modulation were analyzed. Logistic regression was used to determine the predictive power of baseline demographics and diagnostic variables. RESULTS: Test stimulations were performed in 245 patients (226 females; mean age, 56.6 (standard deviation, 12.8) years). Our analysis showed that older age (P = 0.014), external anal sphincter defects (P = 0.005), and repeated procedures after initial failure (P = 0.001) were significantly related to failure. One hundred seventy-three patients (70.6%) were eligible for permanent sacral nerve modulation implantation. The analysis showed no significant predictive factors related to permanent sacral nerve modulation. CONCLUSION: Three predictive factors were negatively associated with the outcome of test stimulation: older age, repeated procedures, and a defect in the external anal sphincter. These factors may indicate lower chances of success for test stimulation but do not exclude patients from sacral nerve modulation treatment. Although assessed in a selected patient group, no factors were predictive of the outcome of permanent stimulation.

Neuromodulation for functional bowel disorders.

In patients with functional bowel disorders not responding to maximal medical treatment, bowel lavage or biofeedback therapy, can nowadays be treated by sacral nerve neuromodulation (SNM). SNM therapy has evolved as a treatment for faecal incontinence and constipation. The exact working mechanism remains unknown. It is known that SNM therapy causes direct stimulation of the anal sphincter and causes changes in rectal sensation and several central nervous system areas. The advantage of SNM therapy is the ability to do a minimally invasive temporary screening phase to assess permanent stimulation outcome. Ideal candidates for SNM therapy are not known. Several studies have described positive and negative predictive factors, but the temporary screening remains the instrument of choice. Clinical results are good and as the technique is developing, fewer complications occur. New indications for SNM include constipation and anorectal or pelvic pain.

Can sensory and/or motor reactions during percutaneous nerve evaluation predict outcome of sacral nerve modulation?

PURPOSE: A major advantage of sacral nerve modulation in the treatment of fecal incontinence is the ability to determine the likely treatment outcome before implantation by means of a percutaneous nerve evaluation and a test stimulation period. This study evaluated the predictive value of both sensory and motor responses during percutaneous nerve evaluation for determining the outcome of subchronic test stimulation and permanent stimulation. METHODS: All percutaneous nerve evaluation procedures performed between 2000 and 2007 were analyzed. Two hundred eight procedures (194 females; mean age, 56.7 years) were included in this study. Correct needle placement was confirmed by typical S-3 sensory and/or motor responses. The sensory and motor responses during the procedure were analyzed in relation to the outcomes of the test stimulation and permanent stimulation. RESULTS: In all, 72.6% of patients had a successful subchronic test stimulation. A total of 13.9% had no motor response. There was no significant difference in outcome between the group with only sensory responses and the group with both sensory and motor responses (P = 0.89; odds ratio, 1.01; 95% confidence interval, 0.42-2.43). Correlation with permanent implantation showed no significant difference between both groups in outcome (P = 0.53; odds ratio, 0.48; 95% confidence interval, 0.17-1.41). CONCLUSION: Positive motor responses during percutaneous nerve evaluation are highly predictive of a successful outcome of subchronic test stimulation and permanent sacral nerve modulation. Sensory responses also have the same predictive value. For this reason, percutaneous nerve evaluation preferably should be performed in awake patients under local anesthesia to avoid missing those who may benefit from permanent stimulation but who do not have a motor response during the procedure.

Can the outcome of pelvic-floor rehabilitation in patients with fecal incontinence be predicted?

PURPOSE: Pelvic-floor rehabilitation does not provide the same degree of relief in all fecal incontinent patients. We aimed at studying prospectively the ability of tests to predict the outcome of pelvic-floor rehabilitation in patients with fecal incontinence. MATERIALS AND METHODS: Two hundred fifty consecutive patients (228 women) underwent medical history and a standardized series of tests, including physical examination, anal manometry, pudendal nerve latency testing, anal sensitivity testing, rectal capacity measurement, defecography, endoanal sonography, and endoanal magnetic resonance imaging. Subsequently, patients were referred for pelvic-floor rehabilitation. Outcome of pelvic-floor rehabilitation was quantified by the Vaizey incontinence score. Linear regression analyses were used to identify candidate predictors and to construct a multivariable prediction model for the posttreatment Vaizey score. RESULTS: After pelvic-floor rehabilitation, the mean baseline Vaizey score (18, SD+/-3) was reduced with 3.2 points (p<0.001). In addition to the baseline Vaizey score, three elements from medical history were significantly associated with the posttreatment Vaizey score (presence of passive incontinence, thin stool consistency, primary repair of a rupture after vaginal delivery at childbed) (R2, 0.18). The predictive value was significantly but marginally improved by adding the following test results: perineal and/or perianal scar tissue (physical examination), and maximal squeeze pressure (anal manometry; R2, 0.20; p=0.05). CONCLUSION: Additional tests have a limited role in predicting success of pelvic-floor rehabilitation in patients with fecal incontinence.

Is a morphologically intact anal sphincter necessary for success with sacral nerve modulation in patients with faecal incontinence?

OBJECTIVE: Sacral nerve modulation (SNM) for the treatment of faecal incontinence was originally performed in patients with an intact anal sphincter or after repair of a sphincter defect. There is evidence that SNM can be performed in patients with faecal incontinence and an anal sphincter defect. METHOD: Two groups of patients were analysed retrospectively to determine whether SNM is as effective in patients with faecal incontinence associated with an anal sphincter defect as in those with a morphologically intact anal sphincter following anal repair (AR). Patients in group A had had an AR resulting in an intact anal sphincter ring. Group B included patients with a sphincter defect which was not primarily repaired. Both groups underwent SNM. All patients had undergone a test stimulation percutaneous nerve evaluation (PNE) followed by a subchronic test over 3 weeks. If the PNE was successful, a permanent SNM electrode was implanted. Follow-up visits for the successfully permanent implanted patients were scheduled at 1, 3, 6 and 12 months and annually thereafter. RESULTS: Group A consisted of 20 (19 women) patients. Eighteen (90%) had a positive subchronic test stimulation. Twelve patients had a successful SNM implant during middle-term follow-up. Group B consisted of 20 women. The size of the defect in the anal sphincter varied between 17% and 33% of the anal circumference. Fourteen (70%) had a positive subchronic test stimulation. Twelve patients had a successful SNM implant during middle-term follow-up. In both groups, the mean number of incontinence episodes decreased significantly with SNM (test vs baseline: P = 0.0001, P = 0.0002). There was no significant difference in resting and squeeze pressures during SNM in group A, but in group B squeeze pressure had increased significantly at 24 months. Comparison of patient characteristics and outcome between groups A and B revealed no statistical differences. CONCLUSION: A morphologically intact anal sphincter is not a prerequisite for success in the treatment of faecal incontinence with SNM. An anal sphincter defect of <33% of the circumference can be effectively treated primarily with SNM without repair.

Electrical stimulation and pelvic floor muscle training with biofeedback in patients with fecal incontinence: a cohort study of 281 patients.

PURPOSE: Pelvic floor rehabilitation is an appealing treatment for patients with fecal incontinence but reported results vary. This study was designed to assess the outcome of pelvic floor rehabilitation in a large series of consecutive patients with fecal incontinence caused by different etiologies. METHODS: A total of 281 patients (252 females) were included. Data about medical history, anal manometry, rectal capacity measurement, and endoanal sonography were collected. Subgroups of patients were defined by anal sphincter complex integrity, and nature and possible underlying causes of fecal incontinence. Subsequently patients were referred for pelvic floor rehabilitation, comprising nine sessions of electric stimulation and pelvic floor muscle training with biofeedback. Pelvic floor rehabilitation outcome was documented with Vaizey score, anal manometry, and rectal capacity measurement findings. RESULTS: Vaizey score improved from baseline in 143 of 239 patients (60 percent), remained unchanged in 56 patients (23 percent), and deteriorated in 40 patients (17 percent). Mean Vaizey score reduced with 3.2 points (P < 0.001). A Vaizey score reduction of >or= 50 percent was observed in 32 patients (13 percent). Mean squeeze pressure (+5.1 mmHg; P = 0.04) and maximal tolerated volume (+11 ml; P = 0.01) improved from baseline. Resting pressure (P = 0.22), sensory threshold (P = 0.52), and urge sensation (P = 0.06) remained unchanged. Subgroup analyses did not show substantial differences in effects of pelvic floor rehabilitation between subgroups. CONCLUSIONS: Pelvic floor rehabilitation leads overall to a modest improvement in severity of fecal incontinence, squeeze pressure, and maximal tolerated volume. Only in a few patients, a substantial improvement of the baseline Vaizey score was observed. Further studies are needed to identify patients who most likely will benefit from pelvic floor rehabilitation.

Sacral neuromodulation; does it affect colonic transit time in patients with faecal incontinence?

OBJECTIVE: Sacral neuromodulation (SNM) has been a successful treatment in urinary voiding disorders for years. A concomitant effect on bowel function was observed leading to the treatment of faecal incontinence with SNM. In this study we describe the effect of SNM on bowel frequency and (segmental) colonic transit time. PATIENTS AND METHODS: Fourteen patients with faecal incontinence who qualified for permanent SNM underwent a colon transit study before and one month after permanent implant. Patients completed a three-week bowel habits diary before and during stimulation. RESULTS: Median incontinence episodes and days per week before SNM were, 8.7 and 4.2, respectively, and both decreased significantly to 0.67 (P = 0001) and 0.5 (P = 0001) during trial screening and to 0.33 (P = 0001) and 0.33 (P = 0001) after permanent implant. The median number of bowel movements per week decreased from 14.7 (6.7-41.7) to 10.0 (3.7-22.7)(P = 0005) during trial screening and to 10.0 (6.0-24.3)(P = 0008) during permanent stimulation. Resting and squeeze pressures did not change significantly during stimulation. Segmental colonic transit time before and during stimulation for right colon, left colon and recto sigmoid were, respectively, 6 (0-25) vs 5 (0-16) hours, 2 (0-29) vs 4 (0-45) hours and 7 (28) vs 8 (0-23) hours. No significant changes were found in both segmental and total colonic transit time; 17 (1-65) vs 25 (0-67) hours. CONCLUSION: SNM in patients with fecal incontinence led to a significant decrease of bowel movements however (segmental) colonic transit time was not influenced.