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 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.

Rectovaginal fistula: a new technique and preliminary results using collagen matrix biomesh.

BACKGROUND: A rectovaginal fistula (RVF) is a debilitating condition that is difficult to treat. Many available techniques are invasive and involve extensive surgery. A local procedure with good closure rates would be preferable as a first step in the treatment of RVF. The aim of this study was the development of a local technique for the closure of RVF with good closure rates to prevent the use of more invasive procedures. METHODS: This was a pilot study. Patients with RVF who had undergone multiple operations in the pelvic area, local radiotherapy, chemotherapy or had been diagnosed with Crohn's disease were included in the study. All had a history of surgery for RVF. A cross-linked collagen matrix biomesh was placed in the rectovaginal septum using a transperineal or a transvaginal approach. The main outcome measure in this study was the closure rate reported as absence of the fistula at 1 year. RESULTS: Twelve patients were included in the study. Absence of fistula at 1 year was 0.64 (95 % confidence interval 0.30-0.85). Three patients (25.0 %) developed a recurrence, two were reoperated on with a gracilis flap transposition, and one was treated with laparoscopic ligation. In one patient (8.3 %), the fistula failed to close within 3 months after the mesh placement. CONCLUSIONS: Our technique shows promising results. A local and simple technique with acceptable closure and morbidity rates, like our local repair with biomesh, would be ideal as a first step in treating RVFs. Long-term results are needed.

Transperineal ultrasound compared to evacuation proctography for diagnosing enteroceles and intussusceptions.

INTRODUCTION: This study concerns the level of agreement between transperineal ultrasound and evacuation proctography for diagnosing enteroceles and intussusceptions. METHOD: In a prospective observational study, 50 consecutive women who were planned to have an evacuation proctography underwent transperineal ultrasound too. Sensitivity, specificity, positive (PPV) and negative predictive value, as well as the positive and negative likelihood ratio of transperineal ultrasound were assessed in comparison to evacuation proctography. To determine the interobserver agreement of transperineal ultrasound, the quadratic weighted kappa was calculated. Furthermore, receiver operating characteristic curves were generated to show the diagnostic capability of transperineal ultrasound. RESULTS: For diagnosing intussusceptions (PPV 1.00), a positive finding on transperineal ultrasound was predictive of an abnormal evacuation proctography. Sensitivity of transperineal ultrasound was poor for intussusceptions (0.25). For diagnosing enteroceles, the positive likelihood ratio was 2.10 and the negative likelihood ratio, 0.85. There are many false-positive findings of enteroceles on ultrasonography (PPV 0.29). The interobserver agreement of the two ultrasonographers assessed as the quadratic weighted kappa of diagnosing enteroceles was 0.44 and that of diagnosing intussusceptions was 0.23. CONCLUSION: An intussusception on ultrasound is predictive of an abnormal evacuation proctography. For diagnosing enteroceles, the diagnostic quality of transperineal ultrasound was limited compared to evacuation proctography.

Responsiveness and interpretability of incontinence severity scores and FIQL in patients with fecal incontinence: a secondary analysis from a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: This study aims to assess the responsiveness and interpretability of the Vaizey score, Wexner score, and the Fecal Incontinence Quality of Life Scale (FIQL) for use in the evaluation of patients with fecal incontinence (FI). METHODS: Eighty patients with FI with a mean age of 59.3 (SD ± 11.9) were enrolled in a randomized controlled trial. The patient-reported outcomes were tested for internal and external responsiveness, longitudinal construct validity, and interpretability. RESULTS: All total scores proved to have both adequate to excellent responsiveness and longitudinal construct validity, and changes were in agreement with subjective improvement. Due to variability in minimally important change estimates (Vaizey score -5 to -3, Wexner score -3 to -2, FIQL 1.1 to 1.2), they should be used as indicators. All patient-reported outcomes showed psychometric or practical limitations. CONCLUSIONS: The instruments available to date to evaluate severity and quality of life in FI do not yet attain the highest levels of psychometric soundness. As the focus of patients may differ from that of physicians, it is recommended that several measures should be included for evaluation. So far, there are suggestions that the Wexner score is most suitable for severity assessment and the FIQL for evaluating quality of life.

A prospective non-randomized two-centre study of patients with passive faecal incontinence after birth trauma and patients with soiling after anal surgery, treated by elastomer implants versus rectal irrigation.

AIM: This study is a prospective evaluation of patients with passive faecal incontinence and patients with soiling treated by elastomer implants and rectal irrigation. PATIENTS AND METHODS: Patients with passive faecal incontinence after birth trauma resulting from a defect of the internal sphincter and patients with soiling after previous anal surgery were included. All patients underwent endo-anal ultrasound, magnetic resonance imaging, and anal manometry. The patients with passive faecal incontinence were initially treated by anal sphincter exercises and biofeedback therapy during half a year. The patients completed incontinence scores, a quality of life questionnaire, and a 2-week diary card. RESULTS: The elastomer group consisted of 30 males and 45 females with a mean age of 53 years (25-77). The rectal irrigation group consisted of 32 males and 43 females with a mean age of 50 years (25-74). At 6 months follow-up, 30 patients with soiling of the rectal irrigation group and only nine patients of the elastomer group were completely cured (p = 0.02). Only three patients with passive faecal incontinence were cured in the rectal irrigation group and none in the elastomer group. Three distal migrations of elastomer implants required removal at follow-up. CONCLUSIONS: After patients had performed anal sphincter exercises, no clear improvement of passive faecal incontinence was obtained by elastomer implants or rectal irrigation. However, rectal irrigation is far more effective than elastomer implants in patients with soiling.

Transvaginal posterior colporrhaphy combined with laparoscopic ventral mesh rectopexy for isolated Grade III rectocele: a prospective study of 27 patients.

AIM: The aim of this study was to evaluate prospectively transvaginal posterior colporrhaphy (TPC) combined with laparoscopic ventral mesh rectopexy (LVR) in patients with a symptomatic isolated rectocele. METHOD: Patients with these complaints underwent dynamic and static MRI. All consecutive patients with a Grade III (4 cm or more) rectocele and without internal/external rectal prolapse, enterocele and external sphincter damage were operated on. The patients completed the Obstructed Defecation Syndrome (ODS) score and the Cleveland Clinic Incontinence Score (CCIS). All tests were repeated after treatment. Dynamic disorders of the pelvic floor detected by MRI were recorded. RESULTS: In 27 patients [median age 67 (46-73) years], TPC combined with LVR was feasible. Complications were limited to port site infection in two patients. Sexual discomfort (n = 8) due to prolapse diminished in six (75%) patients and in one (4%) de novo dyspareunia developed after treatment. The median follow-up was 12 (10-18) months. The median CCIS was 12 (10-16) before treatment and 8 (7-10) after (P < 0.0001). The median ODS score was 19 (17-23) before and 6 (3-10) after treatment (P < 0.0001). There was no change in urinary symptoms. CONCLUSION: TPC combined with LVR for obstructed defaecation and faecal incontinence in patients with Grade III rectocele significantly relieves the symptoms of these disorders.

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.

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.

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.

Evaluation of management of desmoid tumours associated with familial adenomatous polyposis in Dutch patients.

BACKGROUND: The optimal treatment of desmoid tumours is controversial. We evaluated desmoid management in Dutch familial adenomatous polyposis (FAP) patients. METHODS: Seventy-eight FAP patients with desmoids were identified from the Dutch Polyposis Registry. Data on desmoid morphology, management, and outcome were analysed retrospectively. Progression-free survival (PFS) rates and final outcome were compared for surgical vs non-surgical treatment, for intra-abdominal and extra-abdominal desmoids separately. Also, pharmacological treatment was evaluated for all desmoids. RESULTS: Median follow-up was 8 years. For intra-abdominal desmoids (n=62), PFS rates at 10 years of follow-up were comparable after surgical and non-surgical treatment (33% and 49%, respectively, P=0.163). None of these desmoids could be removed entirely. Eventually, one fifth died from desmoid disease. Most extra-abdominal and abdominal wall desmoids were treated surgically with a PFS rate of 63% and no deaths from desmoid disease. Comparison between NSAID and anti-estrogen treatment showed comparable outcomes. Four of the 10 patients who received chemotherapy had stabilisation of tumour growth, all after doxorubicin combination therapy. CONCLUSION: For intra-abdominal desmoids, a conservative approach and surgery showed comparable outcomes. For extra-abdominal and abdominal wall desmoids, surgery seemed appropriate. Different pharmacological therapies showed comparable outcomes. If chemotherapy was given for progressively growing intra-abdominal desmoids, most favourable outcomes occurred after combinations including doxorubicin.

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.

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.

Autologous platelet-derived growth factors (platelet-rich plasma) as an adjunct to mucosal advancement flap in high cryptoglandular perianal fistulae: a pilot study.

AIM: The aim of this study was to explore autologous platelet-rich plasma as an adjunct to the staged mucosal advancement flap in the treatment of perianal fistulae. METHOD: Between February 2006 and May 2007, 10 patients with fistula tracts transversing from the middle-third or upper part of the anal sphincter were treated for at least 3 months with noncutting setons prior to definitive closure by autologous platelet-rich plasma as an adjunct to a mucosal advancement flap. Five patients smoked tobacco. RESULTS: The study group consisted of six women and four men with a median age of 44 (range 30-75) years and a median follow up of 26 (range 17-32) months. One (10%) patient had a recurrent fistula. No new continence disorders developed after definitive treatment in both groups. CONCLUSION: Platelet-rich plasma as an adjunct to a staged mucosal advancement flap for the treatment of perianal cryptoglandular fistulae is a promising treatment modality and seems to establish a high healing rate.

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.

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.

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.

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 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.

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.