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.

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.

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.

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 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.

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.

Effect of sacral neuromodulation on the rectum.

BACKGROUND: Sacral neuromodulation (SNM) is a new treatment for faecal incontinence. At present the exact underlying mechanism is still unclear. Modulation of the sacral reflex arcs might have an effect on rectal sensitivity, wall tension and compliance. METHODS: Fifteen consecutive patients with faecal incontinence who qualified for SNM underwent barostat measurements before and during neuromodulation. An 'infinitely' compliant plastic bag with a volume of 600 ml was placed in the rectum and connected to a computer-controlled barostat system. An isobaric phasic distension protocol was used. Patients were asked to report rectal filling sensations: first sensation (FS), earliest urge to defaecate (EUD) and an irresistible, painful urge to defaecate (maximum tolerated volume; MTV). Rectal wall tension and compliance were calculated. RESULTS: During isobaric phasic distension each patient experienced all rectal filling sensations at the time of stimulation. Median volume thresholds decreased significantly during stimulation, from 98.1 to 44.2 ml for FS (P = 0.003), from 132.3 to 82.8 ml for EUD (P = 0.001) and from 205.8 to 162.8 ml for MTV (P = 0.002). Pressure thresholds tended to be lower for all filling sensations, but only that to evoke MTV was reduced significantly by stimulation (37.3 versus 30.3 mmHg; P = 0.005). Median rectal wall tension for all filling sensations decreased significantly with stimulation. There was no significant difference between compliance before and during stimulation. CONCLUSION: SNM affects rectal sensory perception, but further research is required to clarify the mechanism.

Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse.

BACKGROUND: This study examined the use of sacral nerve stimulation (SNS) to treat faecal incontinence in patients with partial spinal injury. METHODS: Patients selected for SNS had experienced more than one episode of faecal incontinence per week to liquid or solid stool for more than 1 year and had failed maximal conservative treatment. All patients had an intact external anal sphincter. RESULTS: Temporary SNS was performed in 13 patients (median age 58.5 (range 39-73) years). The spinal insults were disc prolapse (six), trauma (four), spinal stenosis (one) or occurred during neurosurgery (two). Twelve patients (eight women and four men) had successful temporary stimulation and proceeded to permanent implantation. The median follow-up time was 12 (range 6-24) months. The mean(s.d.) number of episodes of incontinence decreased from 9.33(7.64) per week at baseline to 2.39(3.69) at last follow-up (P = 0.012). The number of days per week with incontinence and staining decreased significantly (both P < 0.001). Ability to defer defaecation improved from a median of not being able to defer (range 0-1 min) to being able to defer for 5-15 (range 0 to over 15) min (P = 0.022). CONCLUSION: SNS can benefit patients with faecal incontinence following partial spinal injury.

Determination of therapeutic threshold in sacral nerve modulation for faecal incontinence.

BACKGROUND: The aim of the study was to determine the therapeutic stimulation threshold in patients with successful sacral nerve modulation for faecal incontinence. METHODS: Patients who had undergone successful permanent sacral nerve modulator implantation and had been followed up for a minimum of 3 months were included. The sensitivity threshold and motor threshold were determined and correlated with therapeutic response. Patients went home with the stimulator set at 0.6 V below the sensitivity threshold. Each week the voltage was increased by 0.2 V until the sensitivity threshold was reached. The effects on anorectal physiology and continence were recorded. RESULTS: Eight patients (seven women) with a median age of 58.5 years were included. The median follow-up was 6.3 months. The median sensibility threshold volume of rectal sensation was 50 ml, the median urge threshold volume was 140 ml and the median maximum tolerated rectal volume 240 ml. The median number of incontinence episodes and days per week affected by incontinence decreased from 5.0 and 3.8 before operation to 0.7 and 0.7 respectively after follow-up for 3 months. At anorectal manometry the median resting and stimulation anal canal pressures were 57 and 85 mmHg respectively, and remained constant over time. The therapeutic response threshold was significantly lower than the sensitivity threshold (median 1.6 versus 1.7 V; P = 0.042). The median motor threshold was 2.1 V, significantly higher than the sensitivity threshold (P = 0.009). The stimulation threshold for suboptimal therapeutic response was 1.4 V. In five of the eight patients the therapeutic response threshold was the same as the sensitivity threshold. CONCLUSION: Sacral nerve modulation can produce a therapeutic effect below the sensitivity threshold. A lower stimulation voltage increases the lifespan of the pulse generator.

Laparoscopic appendicostomy with cecoplication for antegrade colonic enema procedure.

Successful application of antegrade colonic enema procedure in selected patients with intractable constipation requires creation of an easy catheterizable but continent stoma. We describe a new laparoscopic technique for antegrade colonic enema procedure by using the in situ appendix that is combined with a Nissen-like cecoplication around the appendix to create a one-way valve.

The effects of high field strength MRI on electrodes and pulse generator in dynamic graciloplasty.

OBJECTIVE: Dynamic graciloplasty is a treatment for intractable faecal incontinence. A gracilis muscle is transposed around the anus and stimulated with an implanted pulse generator (IPG). This in vitro study was designed to determine the safety of MRI in patients with implanted electrodes and pulse generators for dynamic graciloplasty. METHODS: Temperatures were measured with fiberoptic probes around the devices in a cadaver model. Current was measured with an oscilloscope connected to electrodes and IPG. Movement and IPG parameter setting were observed before, during and after testing. RESULTS: Minor temperature increase under 1 degrees C were observed around the electrodes. Amplitudes measured were within the range of -1 and +1 Volt. No movement or changing of IPG parameters was noted. CONCLUSION: Changes noted are well within physiological ranges. Dynamic graciloplasty is not a contraindication for high field strength MRI.

[Anal sphincter replacement]. / Ersatz des Analsphinkters.

Presently, deep rectal carcinoma is usually treated by deep anterior rectal resection and colonal anastomosis. Abdominoperineal resection is needed only for the very few patients whose tumors infiltrate the pelvic base or sphincter musculature. This means the loss of normal anal function and thus of normal defecation. Many patients find the idea of a stoma unacceptable. In our experience, the construction of a functional neoanus after abdominoperineal rectal resection is a suitable option for patients in good general health and who are highly motivated.

[Sphincter replacement grafts]. / Sphinkterersatzplastiken.

An anal sphincter replacement graft can be carried out when sphincter lesions occur after unsuccessful conservative or other treatment. Today, two different techniques are used to take over the function of the sphincter. The dynamic gracilis graft can be carried out if a non-atrophied,well innervated m. gracilis is present. This technique is carried out on patients whose incontinence is the result of a trauma,pudendopathy or imperforate anus. It can be extended to the construction of a neo-anus after abdominal resection. The artificial anal sphincter is used whenever the previous method fails or can not be used due to a non-vital, denervated or the lack of the m. gracilis. Older methods such as non-stimulated gracilis, glureus or Thiersch grafts are not commonly used.