Trial design Randomised, multicentre, double-blind crossover trial (with 2 × 16-week periods) of active neurostimulation versus sham stimulation with subsequent open-label follow-up to 58 weeks. Embedded mechanistic sub-study using magnetoencephalography to study bidirectional functional connectivity between brain and anorectum. Methods Participants: adults aged 18–80 years, with chronic symptoms of faecal incontinence refractory to first-line treatments (and meeting national criteria for sacral neuromodulation). Interventions: active: chronic, subsensory (low amplitude) stimulation of a mixed sacral nerve (usually S3) using a commercially available surgically implanted pulse generator; sham: identical implant but turned off (or to 0.05 V). Patient-chosen sub- or supra-sensory open-label stimulation from week 32 to week 58. Primary objectives: (1) to determine whether sub-sensory sacral neuromodulation led to a reduction in total faecal incontinence episodes per week compared to sham stimulation; (2) to identify whether clinical responses to sub-sensory sacral neuromodulation were biologically related to changes in evoked and induced activity between the brain and anorectum. Primary outcome: total faecal incontinence episodes per week based on paper bowel diary performed in the final 4 weeks of each crossover period (allowing 12-week washout). Randomised allocation (1 : 1) to arm 1 (sacral neuromodulation/sham) or arm 2 (sham/sacral neuromodulation) at time of surgery was stratified by sex and centre. Blinding: participants, surgeons and assessors; tamper-proof tape masked stimulation settings. Statistical methods: Poisson regression models failed to converge for the count outcomes, hence paired t-tests were used, and treatment effects summarised by mean differences [with 95% confidence intervals (CIs)]. Sample size: a total of 90 patients (45 per group) were required to detect a 30% reduction in episodes, allowing for 10% loss to follow-up (alpha = 0.05; power 90%). Results Recruitment: a total of 39 patients of 220 screened and 65 pre-enrolled (arm 1: N = 17; arm 2: N = 22) were recruited to the crossover trial at nine sites from the United Kingdom and one site from Ireland between February 2018 and July 2022, of whom only 16 (arm 1: N = 9; arm 2: N = 7) had complete primary outcome data. Nineteen completed follow-up to 58 weeks. Trial delivery was severely affected and terminated early due to COVID-19. Main barriers were the inability to continue face-to-face patient visits, redeployment of research staff to COVID-19 facing clinical roles and cancelling of sacral neuromodulation procedures due to lack of priority for non-urgent surgery. A total of 25 patients underwent magnetoencephalography studies compared to 20 healthy volunteers. Primary outcome (N = 16): sacral neuromodulation conferred a non-significant reduction in mean faecal incontinence episodes per week compared to sham (−0.7, 95% CI −1.5 to 0.0; p = 0.06). Secondary outcomes: in participants who also used the e-event recorder to record the number of faecal incontinence episodes in both periods (n = 7), estimate of effect size was greater but less precise (−1.5, −3.5 to +0.5; p = 0.12). Data suggested successful allocation concealment. Improvements were observed in faecal incontinence symptoms in the follow-up cohort (at 58 weeks) compared to baseline (approx. 3 fewer faecal incontinence episodes per week). A small number of expected adverse events all resolved. Magnetoencephalography studies demonstrated bidirectional afferent evoked cortical and efferent induced anal activity that did not vary greatly from control subjects (n = 20) and appeared unchanged by sacral neuromodulation. Conclusions Due to under-recruitment it is important to interpret the findings on the experimental efficacy of sacral neuromodulation as exploratory. Effects on symptoms observed during double-blinded crossover point to some efficacy over sham, though not large in comparison with placebo responses. The magnitude of effect was highly dependent on method and interpretation of event recording. Study registration Current Controlled Trials ISRCTN98760715. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/144/08) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 19. See the NIHR Funding and Awards website for further award information. Plain language summary A treatment called sacral neuromodulation is commonly offered to adults experiencing bowel (faecal) incontinence. A battery powered unit is implanted into the lower back in the region of the sacrum (tailbone). This is connected to a specially developed lead with electrodes that rest on the nerves of the lower spine. This stimulator then continuously sends electrical impulses to the nerves and muscles that control the lower bowel (rectum and anus). The aim is to improve bowel control. Previous studies have reported a great benefit of sacral neuromodulation in some patients, but others have little or no response. The SUBsensory Sacral Neuromodulation for InContinence trial recruited 39 patients (of 90 intended) who met the current national criteria for sacral neuromodulation. It compared the effect on numbers of weekly faecal incontinence episodes with the device either on (active) or off (sham) using a special study design called a randomised crossover trial. All participants had the device on and off for 16 weeks in random order (crossing over in the middle). Using stimulation below the level that can be felt (subsensory), both the patients and the research team were unaware of whether the stimulator was on or off (called double blinding). Due to COVID-19, only 16 patients had complete data for analysis, which was much less than the intended number of 90. The results showed that patients experienced reductions in faecal incontinence episodes during both on and off periods (i.e. there was a strong placebo effect). However, slightly greater effects were seen during the on period suggesting a possible genuine biological effect of sacral neuromodulation. The study also showed that the way we record symptoms during research trials for example with paper bowel diaries needs improvement, as the bowel diaries were not fully completed by some participants. Although this is the first double-blind trial of its kind for sacral neuromodulation, all conclusions must bear in mind the poor recruitment and retention of patients. Scientific summary Background Faecal incontinence (FI), defined as the recurrent involuntary loss of faecal material leading to a social or hygienic problem, is a common and debilitating condition with profound effects on quality-of-life and high societal costs. Initial treatments including pharmacological and behavioural therapies (e.g. biofeedback) have variable outcomes and are poorly evidenced. Traditional surgical approaches focusing on anal sphincter reconstruction or augmentation are invasive, irreversible, and risk significant morbidity. A stoma is the final option. Chronic low-amplitude stimulation of the mixed sacral spinal nerves using an implanted electrode and pulse generator – sacral neuromodulation (SNM) is a less invasive alternative, now considered the first-line surgical treatment option for adults with FI in whom non-operative therapies have failed to alleviate symptoms. Current evidence for SNM is based on extensive observational data and few randomised trials that are heterogeneous in design and outcomes. Despite having widespread regulatory approval, SNM remains an expensive intervention with need for greater confidence in efficacy. A further concern regarding SNM therapy is the lack of evidence and understanding of the mechanism of any effect. Objectives Our primary aim was to determine the clinical efficacy of sub-sensory chronic low voltage electrical SNM using a commercially-available implantable device in adults with FI in whom conservative treatment has failed. We sought to determine whether SNM, compared to sham, led to a clinically important reduction in weekly FI episodes. The study also included mechanistic studies to examine whether clinical responses to sub-sensory SNM were biologically related to changes in the central pathway between the brain and anorectum. Methods Trial design SUBsensory Sacral Neuromodulation for InContinence (SUBSoNIC) was a multicentre, randomised double-blind crossover trial at nine UK sites and one site in Ireland in which SNM was compared to sham stimulation. We aimed to randomise 90 eligible participants (adults aged 18–80 years, where non-surgical approaches to National Institute for Health and Care Excellence (NICE) standard have failed and meeting minimum FI severity criterion) to two study arms after SNM implantation. Both arms had two intervention periods (ON-OFF or OFF-ON) of 16-week duration (T0–T16 and T16–T32). Efficacy outcomes were derived from assessments in the final 4 weeks of each cross-over period (T12–T16 and T28–T32) thus allowing for almost 3 months intervention before outcome assessments (and adequate washout for participants in the ON–OFF sequence). Mechanistic studies were performed in the final 2 weeks of the 4-week assessment periods in a subgroup of consecutively consenting participants from both arms until data saturation. After completing the crossover phase of the study, participants were followed up for a further 26 weeks. During this time, participants had either sub- or supra-sensory ‘open label’ stimulation based on preference as would have been normal for routine clinical practice. Further efficacy outcomes were recorded at T54–T58 to provide an indication of the short-term effectiveness of SNM within the rigor of a clinical trial unit (CTU)-monitored prospective study. Interventions Chronic low voltage stimulation of the third or fourth sacral root was achieved by surgical implantation of a commercially available Conformité Européenne-marked active implantable (class III) medical device [Medtronic InterStimTM (Medtronic, Minneapolis, MN, USA)] used in accord with the manufacturer’s instructions and local practice. For the active intervention (ON), the clinical team programmed the device using standard settings of a 14-Hz frequency and 210-µs pulse width. Optimal electrode configuration was determined by cumulatively increasing the amplitude of stimulation by 0.1 V from zero for each electrode until the sensory threshold was reached. The amplitude and site of stimulation were recorded for each electrode with the electrode configuration that achieved sensation in the anus or perineum at lowest amplitude being chosen for chronic stimulation. Sub-sensory chronic stimulation was initiated by reducing the amplitude to a level just below the habituated sensory threshold (for blinding). For the sham intervention (OFF), sensory thresholds were recorded identically; however, the level was then adjusted to zero volts or 0.05 V (the latter was required in some participants due to the new device handset limitations). Mechanistic studies were undertaken at the Institute of Health and Neurodevelopment (IHN) at Aston University in a subgroup of patients identified in the Midlands region (compared to 20 healthy volunteers without FI). A protocol including spatial registration (magnetic resonance imaging head) and a series of magnetoencephalographic (MEG) acquisitions measured induced and evoked cortical activity relevant to determining functional connectivity between the anus and brain (using anal electrical stimulation) and brain and anorectum (using volitional anal squeeze). Control paradigms (tibial nerve stimulation and fist clench) were used respectively. Outcomes The primary clinical outcome was reduction in FI events per week (recorded on paper bowel diaries over a 4-week period) in SNM versus sham phase of crossover (16 and 32 weeks). Secondary clinical outcomes including other bowel diary measures, e-event recording and a panel of summative questionnaires were recorded at 16, 32 and 58 weeks. Mechanistic outcomes included spatial localisation, relative cortical source signal strength and latencies of evoked and induced responses. Allocation and blinding Randomised allocation (1 : 1) to group 1 (SNM/sham) or group 2 (sham/SNM) was performed at the time of surgery using an online randomisation system managed by the Pragmatic Clinical Trials Unit at QMUL, with a randomisation list generated by an independent statistician to ensure allocation concealment. Randomisation was stratified by sex and centre with block sizes of four. Members of the research team, statisticians, surgeons who performed the surgical procedure, and participants were blinded to intervention status (SNM or sham). Participants were informed of the allocation ratio of 1 : 1 and that blinding prevented them from knowing in which group they were participating. Tamper-proof tape was used to mask stimulation settings. Sample size and statistics The study was designed to detect a mean 30% reduction between SNM and sham stimulation in FI event rate (ratio 0.7). At 90% power and 5% significance level with a cross-over design this required 90 participants (45 per group), allowing for 10% loss to follow-up. The pre-specified analysis for the primary outcome involved a mixed Poisson regression applied to the counts of FI events, with fixed effects of cross-over period and stratification factors, a random effect of individual, and a random effect of period within individual (the latter to allow for an over-dispersed Poisson distribution). When it came to the analysis, owing in part to the small numbers, the Poisson regression models did not converge for the count outcomes. Instead we applied a paired t-test to the FI rates in order to estimate the difference between SNM and sham with a 95% confidence interval and p-value. Results Clinical results The COVID-19 pandemic had a major effect on trial recruitment and patient retention. The trial was terminated on 24 July 2022 with just 39 patients randomised. Trial delivery was severely affected and terminated early due to COVID-19. Main barriers were the inability to continue face-to-face patient visits, redeployment of research staff to COVID-19 facing clinical roles and cancelling of SNM procedures due to lack of priority for non-urgent surgery. In total, 220 patients were screened for eligibility at nine sites from the UK and one site from Ireland between February 2018 and July 2022. Of these, 155 patients declined study participation or were ineligible due to study specific exclusion criteria. A total of 65 patients were pre-enrolled and consented to the study, of whom 26 did not meet the baseline minimum frequency criteria of FI episodes per week or did not receive an implant. The remaining 39 patients were randomised (arm 1: N = 17; arm 2: N = 22); however, only 16 completed the primary outcome during both cross-over periods (arm 1: N = 9; arm 2: N = 7). The remaining 23 participants withdrew from the study (N = 12), were excluded on the basis of problems of eligibility (N = 5) or did not complete the primary outcome data (N = 6: still included in the cohort follow-up phase). A total of 22 participants started the cohort follow-up phase, although 3 of these participants did not complete the final follow-up visit, leaving 19 participants for the 1-year effectiveness assessment. There were no major differences at baseline between allocated groups. As predicted, about 90% participants were female with mean age about 57 years. Almost all participants reported symptoms of urgency, combined with varying combinations of passive and urge FI. All participants reported previous conservative management for their FI symptoms (as per NICE guidance). Numbers of FI events at baseline were concordant with design assumptions (based on approx. seven events in a 1-week period). Median St Mark’s incontinence score was 19 in both groups, indicating severe symptoms (max score 24). E-event recordings were only undertaken by a minority (14/39) of participants. Test stimulation was performed using a tined lead in 68.6% participants. General anaesthesia was used in 70.6% of procedures and median operating time was 36 minutes (range 30–55 minutes). The lead was positioned in foramina S3 in most participants (91.4%) with some variations in fidelity of siting based on individual electrode responses (only 50% lead placements achieved the ideal published standard of motor or sensory responses for three electrodes < 1V). Primary outcome showed that compared to sham, SNM led to a non-significant mean difference of < 1 FI episode per week [−0.7, confidence interval (CI) −1.5 to 0.0; p = 0.06]. The estimated treatment effect was greater but less precise in the seven participants who had complete e-event data in both periods (−1.5, −3.5 to +0.5; p = 0.12). Secondary outcomes showed small (non-statistical and non-clinically significant) but directional changes favouring SNM versus sham. Adverse events were infrequent (n = 10), non-serious and expected; most resolved during the study. Blinding was successful in masking allocation based on contingencies of correct perception. Cohort study outcomes (from open-label sub- or supra-sensory stimulation) showed substantial benefit in terms of symptom reduction at 1 year in keeping with published observational studies. Mechanistic results A total of 30 patients recruited from the SUBSoNIC study consented to participate of whom only 12 completed the SUBSoNIC clinical study and nine made all three visits to the IHN. The remaining 18 participants contributed to baseline data. There were small statistically significant increases in electrical stimulus amplitude required for tibial evoked cortical responses between FI patients and healthy controls but no differences in latencies (although these were often numerically longer in patients). Anal electrical stimulation produced measurable evoked potentials in the primary somatosensory cortex near the vertex; however, these did not significantly differ between patients and controls in relative amplitude or latency. Induced motor MEG activity was demonstrated throughout the whole sensorimotor strips bilaterally during voluntary fist clenching and anal squeezing activity in both patients and controls at 14–30 Hz (beta band). Given the lack of difference between healthy and FI participants, it was difficult to interpret variations seen between SNM and sham periods in the trial. Conclusions Despite very important caveats of under-recruitment (39 of 90) and attrition (only 16 with complete data), SUBSoNIC is the first randomised study of SNM in a treatment naïve population with proven effective double blinding. Due to the under-recruitment it is important to interpret the findings as exploratory. The mean difference in effect between SNM and sham (−0.7 FI, 95% CI −1.5 to 0.0, episodes perweek) represents a mean percentage reduction of 23.3% (0.7/3.0) when expressed with reference to sham frequency. This effect is less than that sought by the predetermined sample size calculation (0.77 vs. 0.70) and much less than the placebo response (possible placebo effect) based on symptom frequency reductions of a 50% reduction between baseline and sham. Differences in reporting between the paper bowel diaries and the e-event recording re-emphasise the importance of how FI outcomes are measured and the frailties of current approaches. Future work Since the primary objective of the SUBSoNIC trial remains relevant and unanswered, future studies could seek to repeat SUBSoNIC in a post-COVID era. Attention should be paid to improving on current estimation of clinical effect by outcomes research and strict curation of source observations during trial delivery. Placebo ‘effects’ from SNM merit further clinical and mechanistic evaluation. Study registration Current Controlled Trials ISRCTN98760715. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/144/08) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 19. See the NIHR Funding and Awards website for further award information.

OBJECTIVES:In some patients treated for urinary or fecal incontinence with sacral neuromodulation (SNM) persistence of symptoms, a reduction in efficacy or adverse effects of stimulation can occur. In such situations, further programming of the SNM device can help resolve problems. Infrequently hardware failure is detected. This article aims to provide practical guidance to solve sub-optimal outcomes (troubleshooting) occurring in the course of SNM therapy. MATERIALS AND METHODS:A systematic literature review was performed. Collective clinical experience from an expert multidisciplinary group was used to form opinion where evidence was lacking. RESULTS:Circumstances in which reprogramming is required are described. Actions to undertake include changes of electrode configuration, stimulation amplitude, pulse frequency, and pulse width. Guidance in case of loss of efficacy and adverse effects of stimulation, developed by a group of European experts, is presented. In addition, various hardware failure scenarios and their management are described. CONCLUSIONS:Reprogramming aims to further improve patient symptoms or ensure a comfortable delivery of the therapy. Initial changes of electrode configuration and adjustment of stimulation parameters can be performed at home to avoid unnecessary hospital visits. A logical and stepwise approach to reprogramming can improve the outcome of therapy and restore patient satisfaction.

BACKGROUND:Chronic constipation is a prevalent disorder that affects quality of life of patients and consumes resources in healthcare systems worldwide. In clinical practice, it is still considered a challenge as clinicians frequently are unsure as to which treatments to use and when. Over a decade ago, a Neurogastroenterology and Motility journal supplement devoted to the investigation and management of constipation was published (Neurogastroenterol Motil 2009;21(Suppl 2):1). In October 2018, the 3rd London Masterclass, entitled "Contemporary management of constipation" was held. The faculty members of this symposium were invited to write two reviews to present a collective synthesis of talks presented and discussions held during this meeting. The first review addresses epidemiology, diagnosis, clinical associations, pathophysiology, and investigation. PURPOSE:The present is the second of these reviews, providing contemporary perspectives and clinical challenges regarding behavioral, conservative, medical, and surgical treatments for patients presenting with constipation. It includes a management algorithm to guide clinical practice.

BackgroundIn sacral neuromodulation (SNM), stimulation programming plays a key role to achieve success of the therapy. However to date, little attention has been given to the best ways to set and optimize SNM programming during the test and chronic stimulation phases of the procedure.ObjectiveStandardize and make SNM programming easier and more efficient for the several conditions for which SNM is proposed.MethodsSystematic literature review and collective clinical experience report.ResultsThe basic principles of SNM programming are described. It covers choice of electrode configuration, stimulation amplitude, pulse frequency and pulse widths, while use of cycling is also briefly discussed. Step-by-step practical flow charts developed by a group of 13 European experts are presented.ConclusionsProgramming of SNM therapy is not complex. There are few programming settings that seem beneficial or significantly impact patient outcomes. Only four basic electrode configurations could be identified according to four different options to define the cathode. In a majority of patients, the proposed stimulation parameters will allow a satisfactory improvement for long periods of time. A regular follow-up is, however, necessary to assess and eventually optimize results, as well as to reassure patients.

Faecal incontinence has been defined by the International Continence Society as the involuntary loss of solid or liquid faeces, with the term anal incontinence reserved for patients that additionally have involuntary loss of flatus. It is a debilitating and often overlooked condition which can have a detrimental effect on an individual's self-esteem and quality of life. Despite this, due to the stigma and embarrassment of symptoms, patients often fail to seek medical opinion and instead opt to live in silence with their condition. Patients may experience different types of incontinence. Some subjects have symptoms of urgency with the inability to defer defecation. This often leads to frequent and severe symptoms of urge faecal incontinence. Soiling leads to a small volume of faeces, which can lead to perianal uncleanliness and soiling of underwear. The embryological formation of the bowel can be seen as early as the third week of gestation, where ventral folding of yolk sac to form gut tube occurs.

BACKGROUND: Unilateral posterior tibial nerve stimulation has been shown to improve fecal incontinence in the short term. Posterior tibial nerve stimulation is believed to work by stimulation of the ascending afferent spinal pathways. Bilateral stimulation may activate more of these pathways. This may lead to an improved therapeutic effect. OBJECTIVE: The aim of this study was to assess the efficacy of bilateral transcutaneous posterior tibial nerve stimulation for fecal incontinence. DESIGN: This was a single-group pilot prospective study. SETTING: The study was conducted from June 2012 to September 2012 at the authors’ institution. PATIENTS: Twenty patients with fecal incontinence were recruited consecutively. Conservative therapy had failed to improve the fecal incontinence in all 20 patients. INTERVENTION: All patients received 30 minutes of daily bilateral stimulation for 6 weeks. The bilateral stimulation was administered by each patient at home. No further stimulation was given after 6 weeks, and the patients were followed up until their symptoms returned to the prestimulation state (baseline). MAIN OUTCOME MEASURE: The primary outcome measure was a change in the frequency of incontinent episodes per week. RESULTS: Seventeen patients completed 6 weeks of treatment. Two patients achieved complete continence. Ten (59%) achieved a ≥50% reduction in frequency of incontinent episodes. Overall, there was a significant reduction in median (interquartile range) frequency of incontinent episodes per week of 6 (8.25) to 2 (7.25) (p = 0.03). There was a significant improvement in the ability to defer defecation from 3 (4) to 5 (8) minutes (p = 0.03). There was no change in the St Mark's incontinence score. One domain of the Rockwood fecal incontinence quality-of-life score and of the Medical Outcomes Study Short Form 36 score improved significantly. LIMITATIONS: This study was limited by its small size and its lack of blinding and control. CONCLUSIONS: Bilateral transcutaneous posterior tibial nerve stimulation appears to be a cheap and effective treatment for fecal incontinence. It can easily be used by the patient at home.

Aims of course/workshop Sacral nerve stimulation is a well accepted minimal invasive treatment for certain bladder and bowel dysfunctions, but tibial and pudendal nerve stimulation are currently emerging as alternatives. The aim of the workshop is to guide decision making in patients in which neuromodulation therapy is considered, and to bridge the gap between bladder and bowel management. The similarities and differences between the different forms of neuromodulation will be discussed focusing on mechanism of action, clinical efficacy, patient selection criteria and adverse events. At the end of the workshop, the audience should have a clear overview of the different modalities and a possible algorithm to choose the optimal method for the individual patient.

BACKGROUND AND OBJECTIVE:In patients with fecal incontinence who do not benefit from medical or behavioral treatments sacral nerve stimulation is now considered a first-line procedure. Although the efficacy of treatment appears to be sustained in the short and medium term, the long-term results of therapy are relatively unknown.OBJECTIVE:We report the results of chronic sacral nerve stimulation in patients who have had more than 8 years of therapy.DESIGN AND SETTINGS:All patients who underwent sacral nerve stimulation for fecal incontinence from 1996 to 2002 were followed up prospectively. Data were collected prospectively by the use of bowel habit diaries and St Mark's continence scores. Treatment success was defined as >50% reduction in episodes of fecal incontinence with sacral nerve stimulation in comparison with baseline symptoms.RESULTS:Between January 1996 and December 2002, 25 patients (male/female 2:23; median age, 54 years (range, 35-68 years) underwent temporary sacral nerve stimulation. Twenty-three (92%) patients had a greater than 50% improvement in their ability to defer defecation during the trial phase and were considered suitable for chronic stimulation. Over a median follow-up of 114 months (range, 96-164 months), full continence was maintained in 12 (48%) of the 23 patients who received a neurostimulator implant. Two patients lost efficacy at 48 and 60 months after permanent implant for unknown reasons and had the device removed. Three patients died at 3, 8, and 9 years after permanent implant because of unrelated comorbidities. Nine patients required a change of battery at a mean (SD) of 87 (13.5) months.CONCLUSIONS:Sacral nerve stimulation can maintain a persistent clinical benefit in the long term for the majority of patients. Some patients will experience deterioration in their symptoms over time, for reasons yet unknown.

Objective Traditional surgical procedures for intractable idiopathic constipation are associated with a variable outcome and substantial morbidity. The symptomatic response, physiological effect and effect on quality of life of sacral nerve stimulation (SNS) were evaluated in patients with constipation ( slow transit and normal transit with impaired evacuation).Methods In a prospective study at five European sites patients who failed conservative treatment underwent 21 days test stimulation. Patients with >50% improvement in symptoms underwent permanent neurostimulator implantation. Primary end points were increased defecation frequency, decreased straining and decreased sensation of incomplete evacuation.Results 62 patients ( 55 female, median age 40 years) underwent test stimulation, of whom 45 (73%) proceeded to chronic stimulation. 39 (87%) of these 45 patients achieved treatment success. After a median 28 ( range 1-55) months follow-up, defecation frequency increased from 2.3 to 6.6 evacuations per week (p<0.001). Days per week with evacuation increased from 2.3 to 4.8 (p<0.001). There was a decrease in time spent toileting (10.5 to 5.7 min, p=0.001), straining (75-46% of successful evacuations, p<0.001), perception of incomplete evacuation (71.5-46% of successful evacuations, p<0.001) and subjective rating of abdominal pain and bloating (p<0.001). Cleveland Clinic constipation score (0=no to 30=severe constipation) decreased from 18 to 10 (p<0.001). Visual analogue scale (VAS) score (0=severe to 100=no symptoms) increased from 8 to 66 (p<0.001). Patients with slow and normal transit benefited. Quality of life significantly improved. Colonic transit normalised in half of those with baseline slow transit (p=0.014).Conclusion SNS is effective in the treatment of idiopathic slow and normal transit constipation resistant to conservative treatment.

The evaluation and testing of conditions attributed to the posterior compartment of the pelvic floor is an important component in the management of patients presenting with fecal incontinence, constipation, and anal pain. In recent years, numerous advances in radiological and physiological investigatory techniques have become available to the clinician. This can enable the underlying pathogenesis of the condition to be determined, which in turn can aid diagnosis and guide medical, behavioral, and surgical treatment. This review looks at current concepts and advances in the evaluation and testing of posterior pelvic floor disorders. (C) 2010 Published by Elsevier Inc.

In patients with faecal incontinence related to isolated internal anal sphincter (IAS) disruption, conservative management is the mainstay of treatment. Surgical repair of the internal sphincter is not successful. This study evaluated the use of sacral nerve stimulation (SNS) in those with faecal incontinence and IAS disruption in whom medical and behavioural treatments had failed.

PURPOSE:Results from early studies on sacral nerve stimulation are based on a stimulation electrode lead that was placed under direct vision during an open surgical procedure. A percutaneous inserted lead, introduced in 2002, is now widely used. This study was designed to investigate differences in clinical efficacy and adverse complications between the two methods of lead placement.METHODS:Prospectively collected data were analyzed for 48 patients who had undergone permanent sacral nerve stimulation for fecal incontinence at a single institution between 1997 and 2006. Eighteen patients had undergone open lead placement (Group 1) and 30 patients percutaneous lead placement (Group 2).RESULTS:Median follow-up was 51 (range, 22-106) months for Group 1 and 8 (range, 1-40) months for Group 2 patients. There was no difference in patient demographics, severity of incontinence, or physiologic parameters between the two groups. Lead type did not affect the outcome of chronic stimulation with reductions in total episodes of incontinence being similar between the two groups (P = 0.448). No difference in infection or lead dislocation rate between the two groups was identified.CONCLUSIONS:The percutaneously inserted lead seems to be equal to the open inserted lead in terms of clinical efficacy and complication rate in the short-term.

Purpose: Sphincter repair is the standard treatment for fecal incontinence secondary to obstetric external anal sphincter damage; however, the results of this treatment deteriorate over time. Sacral nerve stimulation has become an established therapy for fecal incontinence in patients with intact sphincter muscles. This study investigated its efficacy as a treatment for patients with obstetric-related incontinence. Methods: Fecally incontinent patients with external sphincter defects who would normally have undergone overlapping sphincter repair as a primary or repeat procedure were included. Eight consecutive women (median age, 46 (range, 35-67) years) completed temporary screening; all eventually had permanent implantation. Results: Six of eight patients had improved continence at median follow-up of 26.5 (range, 6-40) months. Fecal incontinent episodes improved from 5.5 (range, 4.5-18) to 1.5 (range, 0-5.5) episodes per week (P= 0.0078). Urgency improved in five patients, with ability to defer defecation improving from a median of <1 (range, 0-5) minute to 1 to 5 (range, 1 to >15) minutes (P= 0.031, all 8 patients). There was no change in anal manometry or rectal sensation. There was significant improvement in lifestyle, coping/behavior, depression/self-perception, and embarrassment as measured by the American Society of Colon and Rectal Surgery fecal incontinence quality of life score. Conclusions: Sacral nerve stimulation is potentially a safe and effective minimally invasive treatment for fecal incontinence in patients withde novoexternal anal sphincter defects or defects after unsuccessful previous external anal sphincter repair, although numbers remain small.

Obstetric sphincter damage is the most common cause of fecal incontinence in women. This review aimed to survey the literature, and reach a consensus, on its incidence, risk factors, and management.This systematic review identified relevant studies from the following sources: Medline, Cochrane database, cross referencing from identified articles, conference abstracts and proceedings, and guidelines published by the National Institute of Clinical Excellence (United Kingdom), Royal College of Obstetricians and Gynaecologists (United Kingdom), and American College of Obstetricians and Gynecologists.A total of 451 articles and abstracts were reviewed. There was a wide variation in the reported incidence of anal sphincter muscle injury from childbirth, with the true incidence likely to be approximately 11% of postpartum women. Risk factors for injury included instrumental delivery, prolonged second stage of labor, birth weight greater than 4 kg, fetal occipitoposterior presentation, and episiotomy. First vaginal delivery, induction of labor, epidural anesthesia, early pushing, and active restraint of the fetal head during delivery may be associated with an increased risk of sphincter trauma. The majority of sphincter tears can be identified clinically by a suitably trained clinician. In those with recognized tears at the time of delivery repair should be performed using long-term absorbable sutures. Patients presenting later with fecal incontinence may be managed successfully using antidiarrheal drugs and biofeedback. In those who fail conservative treatment, and who have a substantial sphincter disruption, elective repair may be attempted. The results of primary and elective repair may deteriorate with time. Sacral nerve stimulation may be an appropriate alternative treatment modality.Obstetric anal sphincter damage, and related fecal incontinence, are common. Risk factors for such trauma are well recognized, and should allow for reduction of injury by proactive management. Improved classification, recognition, and follow-up of at-risk patients should facilitate improved outcome. Further studies are required to determine optimal long-term management.

Background and Aims:Obstetric sphincter damage is the most common cause of fecal incontinence in women. This review aimed to survey the literature, and reach a consensus, on its incidence, risk factors, and management. Method:This systematic review identified relevant studies from the following sources: Medline, Cochrane database, cross referencing from identified articles, conference abstracts and proceedings, and guidelines published by the National Institute of Clinical Excellence (United Kingdom), Royal College of Obstetricians and Gynaecologists (United Kingdom), and American College of Obstetricians and Gynecologists. Results:A total of 451 articles and abstracts were reviewed. There was a wide variation in the reported incidence of anal sphincter muscle injury from childbirth, with the true incidence likely to be approximately 11% of postpartum women. Risk factors for injury included instrumental delivery, prolonged second stage of labor, birth weight greater than 4 kg, fetal occipitoposterior presentation, and episiotomy. First vaginal delivery, induction of labor, epidural anesthesia, early pushing, and active restraint of the fetal head during delivery may be associated with an increased risk of sphincter trauma. The majority of sphincter tears can be identified clinically by a suitably trained clinician. In those with recognized tears at the time of delivery repair should be performed using long-term absorbable sutures. Patients presenting later with fecal incontinence may be managed successfully using antidiarrheal drugs and biofeedback. In those who fail conservative treatment, and who have a substantial sphincter disruption, elective repair may be attempted. The results of primary and elective repair may deteriorate with time. Sacral nerve stimulation may be an appropriate alternative treatment modality. Conclusions:Obstetric anal sphincter damage, and related fecal incontinence, are common. Risk factors for such trauma are well recognized, and should allow for reduction of injury by proactive management. Improved classification, recognition, and follow-up of at-risk patients should facilitate improved outcome. Further studies are required to determine optimal long-term management.

Patients with functional anorectal pain in the absence of an organic cause often have symptoms that are resistant to conventional medical and behavioral therapy. This study assessed the use of sacral nerve stimulation in the treatment of this condition.