Nerve Stimulation For Faecal Incontinence Research Articles

Short-term clinical and manometric outcomes of percutaneous tibial nerve stimulation for faecal incontinence: a large single-centre series

BackgroundFaecal incontinence (FI) is common, with a significant impact on quality of life. Percutaneous tibial nerve stimulation (PTNS) is a therapy for FI; however, its role has recently been questioned. Here we report the short-term clinical and manometric outcomes in a large tertiary centre.MethodsA retrospective review of a prospective PTNS database was performed, extracting patient-reported FI outcome measures including bowel diary, the St Marks’s Incontinence Score (SMIS) and Manchester Health Questionnaire (MHQ). Successful treatment was > 50% improvement in symptoms, whilst a partial response was 25–50% improvement. High-resolution anorectal manometry (HRAM) results before and after PTNS were recorded.ResultsData were available from 135 patients [119 (88%) females; median age: 60 years (range: 27–82years)]. Overall, patients reported a reduction in urge FI (2.5–1) and passive FI episodes (2–1.5; p < 0.05) alongside a reduction in SMIS (16.5–14) and MHQ (517.5–460.0; p < 0.001). Some 76 (56%) patients reported success, whilst a further 20 (15%) reported a partial response. There were statistically significant reductions in rectal balloon thresholds and an increase in incremental squeeze pressure; however, these changes were independent of treatment success.ConclusionPatients report PTNS improves FI symptoms in the short term. Despite this improvement, changes in HRAM parameters were independent of this success. HRAM may be unable to measure the clinical effect of PTNS, or there remains the possibility of a placebo effect. Further work is required to define the role of PTNS in the treatment of FI.

Long-term efficacy of percutaneous tibial nerve stimulation for faecal incontinence and a new approach for partial responders

BackgroundThe aim of the present study was to evaluate the long-term efficacy of percutaneous tibial nerve stimulation (PTNS) for patients with faecal incontinence (FI) refractory to conservative treatment. Secondary aims were to identify predictors of response and validate new treatment pathways for partial responders.MethodsA prospective, interventional study was carried out in a specialist defecatory disorder unit from a university hospital between January 2010 and June 2017 on patients > 18 years old with FI refractory to conservative treatment. Thirty-minute PTNS sessions were performed in three phases (weekly, biweekly and monthly) up to a year, with clinical reassessment at 3, 6, 12 and 36 months.Patients were classified as optimal responders when their pretreatment Wexner score decreased > 50%; partial responders when it decreased 25–50%; and insufficient responders if it decreased < 25%. Only optimal and partial responders progressed into successive phases.ResultsBetween 2010 and 2017, 139 patients (110 women, median age 63 years [range 22–82 years]) were recruited. After the first phase, 4 patients were optimal responders, 93 were partial responders and 36 were insufficient responders. At 6 and 12 months, 66 and 89 patients respectively were optimal responders, with an optimal response rate of 64% at the end of treatment. A total of 93.3% patients with a partial response initially finally became optimal responders. Furthermore, at 36 months, 71.9% of patients were still optimal responders without supplementary treatment, although their quality of life did not improve significantly. Baseline Wexner scores ≤ 10 and symptom duration < 1 year were identified as predictive factors for positive responses to PTNS.ConclusionsPatients undergoing PTNS for 1 year following this protocol had optimal long-term responses. PTNS sessions for up to 1 year in patients who were partial responders prevents a high percentage of them from needing more invasive treatments, and maintains long-term continence in patients who were optimal responders.

Long-term outcome of sacral nerve stimulation for faecal incontinence.

Sacral nerve stimulation (SNS) is a minimally invasive treatment for faecal incontinence (FI). We report our experience of patients who have undergone SNS for FI with a minimum of 5 years' follow-up. This is a single centre prospective observational study with the aim to assess the long-term function of SNS. All patients implanted with SNS were identified from our prospective database. The date of implantation, first and last clinic follow-up, surgical complications and St Mark's incontinence scores were abstracted and analysed. From 1996 to 2014, 381 patients were considered for SNS. Of these, 256 patients met the study inclusion criteria. Median age at implantation was 52years (range 18-81). The ratio of women to men was 205:51. Indications were urge FI (25%), passive FI (17.9%) and mixed FI (57%). The median of the incontinence score at baseline was 19/24 and this improved to 7/24 at the 6-month follow-up. Of the total cohort, 235 patients received a medium-term follow-up (median 110months, range 12-270) with a median continence score of 10/24 which was also confirmed at the telephone long-term follow-up on 185 patients (132months, range 60-276). This study demonstrates that SNS is an effective treatment in the long term. SNS results in an improvement of validated scores for approximately 60% of patients; however, there is a significant reduction of efficacy over time due to underlying causes.

Costs and outcomes of sacral nerve stimulation for faecal incontinence in New Zealand: a 10-year observational study.

Faecal incontinence is a debilitating condition that affects more than 10% of New Zealanders. In well-selected cohorts, sacral nerve stimulation (SNS) offers a therapeutic option for patients refractory to conservative and other surgical treatments. The aim of this study was to define the clinical efficacy, rate of reinterventions and explants and healthcare costs associated with SNS in the New Zealand setting. Clinical records of all consecutive patients undergoing SNS at Auckland District Health Board between 2008 and 2019 were retrospectively reviewed and paired with the results of a postal survey to 100 patients who had retained the implant at August 2019. Over the 10-year period, 142 patients underwent stage 1 SNS, of which 126 (88.7%) progressed to a permanent implant and 108 (76.1%) had retained the implant at a median follow-up of 41.2 months. SNS therapy significantly reduced weekly faecal incontinence episodes (P < 0.001), medication use (P < 0.001) and pad use (P = 0.01) at median 41.2 months. Complications were common, with infections in 9.2%, lead fractures in 4.9% and component migrations in 12.7%. The probability of retaining the same battery at 6.3 years was >90%. In total, reintervetion was necessary in 41.5% of the cohort. SNS therapy was expensive, costing >NZ$30 000 for implantation, increasing to >NZ$46 000 if a further reintervention was required. SNS is an effective long-term therapy for faecal incontinence. However, it is expensive and associated with a high rate of reinterventions and explants.

Posterior Tibial Nerve Stimulation in Fecal Incontinence: A Systematic Review and Meta-Analysis.

Introduction:The present systematic review and meta-analysis aims to investigate the role of Posterior Tibial Nerve Stimulation (PTNS) in the control of Fecal Incontinence (FI).Methods:Two independent reviewers extensively searched in the electronic databases of Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, CINAHL, and Scopus for the studies published until the end of 2016. Only randomized clinical trials were included. The studied outcomes included FI episodes, FI score, resting pressure, squeezing pressure, and maximum tolerable pressure. The data were reported as Standardized Mean Differences (SMD) with 95% confidence interval.Results:Five articles were included in the present study (249 patients under treatment with PTNS and 239 in the sham group). Analyses showed that PTNS led to a significant decrease in the number of FI episodes (SMD=−0.38; 95% CI: −0.67–0.10; P=0.009). Yet, it did not have an effect on FI score (SMD=0.13; 95% CI: −0.49–0.75; P=0.68), resting pressure (SMD=0.12; 95% CI: −0.14–0.37; P=0.67), squeezing pressure (SMD=−0.27; 95% CI: −1.03–0.50; P=0.50), and maximum tolerable pressure (SMD=−0.10; 95% CI: −0.40–0.24; P=0.52).Conclusion:Based on the results, it seems that the prescription of PTNS alone cannot significantly improve FI.

Bioelectric neuromodulation for gastrointestinal disorders: effectiveness and mechanisms.

The gastrointestinal tract has extensive, surgically accessible nerve connections with the central nervous system. This provides the opportunity to exploit rapidly advancing methods of nerve stimulation to treat gastrointestinal disorders. Bioelectric neuromodulation technology has considerably advanced in the past decade, but sacral nerve stimulation for faecal incontinence currently remains the only neuromodulation protocol in general use for a gastrointestinal disorder. Treatment of other conditions, such as IBD, obesity, nausea and gastroparesis, has had variable success. That nerves modulate inflammation in the intestine is well established, but the anti-inflammatory effects of vagal nerve stimulation have only recently been discovered, and positive effects of this approach were seen in only some patients with Crohn's disease in a single trial. Pulses of high-frequency current applied to the vagus nerve have been used to block signalling from the stomach to the brain to reduce appetite with variable outcomes. Bioelectric neuromodulation has also been investigated for postoperative ileus, gastroparesis symptoms and constipation in animal models and some clinical trials. The clinical success of this bioelectric neuromodulation therapy might be enhanced through better knowledge of the targeted nerve pathways and their physiological and pathophysiological roles, optimizing stimulation protocols and determining which patients benefit most from this therapy.

The functional outcome of sacral nerve stimulation for faecal incontinence can be improved by using lead model 3889 and a standardized implantation technique.

Sacral nerve stimulation has been recognized as an effective treatment option for faecal incontinence when conservative therapy has failed. Refinement of the procedural technique and the use of a curved stylet may improve the functional outcome. Our aim was to explore the relationship between lead model, functional outcome, stimulation amplitude and the need for extra visits during the first year of follow-up. Patient data from May 2009 to February 2017, which were prospectively collected in a local database, were extracted and analysed for differences between lead model and improvement in incontinence scores, stimulation amplitude and the need for additional visits during the first year of follow-up. A foramen lead model 3093(straight stylet) was used in 134 patients and lead model 3889(curved stylet) was used in 40 patients. There were no differences in baseline characteristics or incontinence scores. Comparing results between the two lead models we found that the improvement (delta value) in the Wexner score at 6months' follow-up (P=0.05) and the St Mark's score at 12months' follow-up (P=0.02) was greater in patients implanted with lead model 3889(curved stylet) compared with patients implanted with lead model 3093(straight stylet). Patients implanted with lead model 3889 (curved stylet) were less likely to have to alter the stimulation amplitude or pole configuration during the first year of follow-up (P=0.04). No difference was found for stimulation amplitude (P=0.170) or the need for additional visits (P=0.663). Lead model 3889 (curved stylet) improves functional results compared with lead model 3093 (straight stylet) during the first year of follow-up. Lead model 3889 (curved stylet) reduces the need for reprogramming but has no influence on stimulation amplitude or the number of additional visits required.

Sacral nerve stimulation for faecal incontinence and constipation in adults.

Sacral nerve stimulation for faecal incontinence and constipation in adults.

Effectiveness of sacral nerve stimulation in fecal incontinence after multimodal oncologic treatment for pelvic malignancies: a multicenter study with 2-year follow-up.

To assess whether sacral nerve stimulation (SNS) is an effective treatment for severe fecal incontinence (FI) after radiotherapy (RT)/chemoRT (CRT) in combination with pelvic surgery. A multicenter study was conducted on patients with FI that developed after multimodal therapy for pelvic tumors and was refractory to non-operative management, who were treated with SNS between November 2009 and November 2012. Data were prospectively collected and retrospectively analyzed. Cleveland Clinic FI score (CCFIS), FI episodes per week, FI Quality of Life (FIQoL), anorectal manometry and pudendal nerve terminal motor latency were evaluated before and after SNS. Eleven patients (seven females, mean age 67.3±4.8years) were evaluated in the study period. Multimodal treatments included surgery and CRT (four rectal, two cervical and one prostate cancers), surgery and RT (one cervical and two endometrial cancers) and CRT (one anal cancer). The mean radiation dose was 5.3Gy, and mean interval between the end of RT and onset of FI was 43.7±23months. Before SNS, the mean CCFIS and the mean number of FI episodes per week were 15.7±2.8 and 12.3±4.2, respectively. At 12-month follow-up, mean CCFIS improved to 3.6±1.8 (p=0.003) and the mean number of FI episodes decreased to 2.0±1.9 per week (p=0.003). These results persisted at 24-month follow-up. Significant improvement was also observed for each of the four domains of FIQoL at 12- and 24-month follow-up. Anorectal manometry values did not change significantly at follow-up. SNS is feasible and may be an effective therapeutic option for FI after multimodal treatment of pelvic malignancies.

Trends in Surgeon-Level Utilization of Sacral Nerve Stimulator Implantation for Fecal Incontinence in New York State.

There is a paucity of real-world data regarding surgeon utilization of sacral nerve stimulation for fecal incontinence compared with anal sphincteroplasty. This study aims to examine trends in sacral nerve stimulation use compared with sphincteroplasty for fecal incontinence and surgeon-level variation in progression to implantation of the pulse generator. This is a population-based study. Patients with fecal incontinence between 2011 and 2014 in New York who underwent stage 1 of the sacral nerve stimulation procedure were selected. For the comparison with sphincteroplasty, patients with fecal incontinence who underwent anal sphincteroplasty between 2008 and 2014 were included. The main outcomes after sacral nerve stimulation generator placement were unplanned 30-day admission, emergency department visit within 30 days, revision or explant of leads or generator, and 30-day mortality. Six hundred twenty-one patients with fecal incontinence underwent a stage 1 procedure with 79.7% progressing to stage 2. There has been an increase in the number of sacral nerve stimulation cases per year as well as the number of surgeons performing the procedure. The rate of progression to stage 2 among patients treated by colorectal surgeons was 80.2% compared with 77.0% among those treated by noncolorectal surgeons. Among those who completed stage 2, there were 3 (0.5%) unplanned 30-day admissions, 24 (4.4%) emergency department visits within 30 days, and 0 mortalities within 30 days. Thirty-two (6.5%) patients had their leads or pulse generator revised or explanted. There was a significant decrease in annual sphincteroplasty cases and the number of providers performing the procedure starting in 2011. We lacked data regarding patient and physician decision making and the severity of disease. Sacral nerve stimulation for fecal incontinence is increasing in popularity with an increasing number of surgeons utilizing sacral nerve stimulation for fecal incontinence rather than sphincteroplasty. See Video Abstract at http://links.lww.com/DCR/A450.

Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence.

Background:Subcutaneous sacral nerve stimulation is recommended by the United Kingdom (UK) National Institute for Health and Care Excellence (NICE) as a second-line treatment for patients with faecal incontinence who failed conservative therapy. Sacral nerve stimulation is an invasive procedure associated with complications and reoperations. This study aimed to investigate whether delivering less invasive and less costly percutaneous tibial nerve stimulation prior to sacral nerve stimulation is cost-effective.Methods:A decision analytic model was developed to estimate the cost-effectiveness of percutaneous tibial nerve stimulation with subsequent subcutaneous sacral nerve stimulation versus subcutaneous sacral nerve stimulation alone. The model was populated with effectiveness data from systematic reviews and cost data from randomized studies comparing both procedures in a UK National Health Service (NHS) setting.Results:Offering percutaneous tibial nerve stimulation prior to sacral nerve stimulation (compared with delivering sacral nerve stimulation straight away) was both more effective and less costly in all modeled scenarios. The estimated savings from offering percutaneous tibial nerve stimulation first were £662–£5,697 per patient. The probability of this strategy being cost-effective was around 80% at £20,000–£30,000 per quality-adjusted life-year (QALY).Conclusion:Our analyses suggest that offering patients percutaneous tibial nerve stimulation prior to sacral nerve stimulation can be both cost-effective and cost-saving in the treatment of faecal incontinence.

Meta-analysis of sacral nerve stimulation for fecal incontinence

To evaluate the efficacy of sacral nerve stimulation (SNS) therapy for fecal incontinence. Clinical researches which evaluated the efficacy of SNS and were published between 1946 and 2016 were systematically searched from electronic databases, including PubMed, Ovid Medline, Web of Science, Wanfang database and Chinese Journal Full-text Database. Grey area literatures were also searched. Influence of SNS therapy on fecal incontinence episodes (FIE) or Wexner incontinence score (WIS) was systematically evaluated. The statistical analysis was performed by RevMan5.2. A total of 6 studies including 270 patients (147 patients in SNS group and 123 patients in control group) with fecal incontinence were enrolled in this systematic review. SNS therapy was associated with a significant reduction in FIE (SMD=-0.69, 95%CI: -0.97 to -0.41, P<0.001) and a significant reduction in WIS (SMD=-5.05, 95%CI: -8.73 to -1.36, P=0.007). Sensitivity analysis showed that the results of this study were stable and the direction and significance of results were not changed (P=0.000 for both). Publication bias was not found by funnel picture in this study. SNS significantly improves the outcome of patients with fecal incontinence.

Factors Associated With Efficacy of Percutaneous Tibial Nerve Stimulation for Fecal Incontinence, Based on Post-Hoc Analysis of Data From a Randomized Trial

A recent randomized, multi-center, phase 3 trial, performed in the United Kingdom (Control of Fecal Incontinence using Distal Neuromodulation Trial), demonstrated no significant clinical benefit of percutaneous tibial nerve stimulation (PTNS) compared to sham stimulation in patients with fecal incontinence (FI). However, this study did not analyze predictors of response. We used data from this trial to identify factors that predict the efficacy of PTNS in adults with FI. The study population comprised 205 patients from the CONtrol of Fecal Incontinence using Distal NeuromodulaTion Trial. The primary outcome was a binary indicator of success (≥50% reduction in weekly FI episodes after 12 weeks of treatment) or failure, as per the original trialcharacteristics including baseline FI symptom type, defecatory urgency, and co-existent symptoms of baseline liquid stool consistency and obstructive defecation (OD) were defined a priori. Univariable and multivariable analyses were performed to explore these factors as predictors of response to PTNS and sham. In both univariable and multivariable analysis, the presence of OD symptoms negatively predicted outcome in patients who received PTNS (OR, 0.38; 95% CI, 0.16-0.91; P= .029), and positively predicted sham response (OR, 3.45; 95% CI, 1.31-9.21; P= .012). No other tested variable affected outcome. Re-analysis of the primary outcome excluding patients with OD symptoms (n= 112) resulted in a significant clinical effect of PTNS compared to sham (48.9% vs 18.2% response, P= .002; multivariable OR, 4.71; 95% CI, 1.71-12.93; P= .003). Concomitant OD symptoms negatively affected the clinical outcome of PTNS vs sham in a major randomized controlled trial. Future appropriately designed studies could further explore this observation with potential for future stratified patient selection.

Dynamic Article: Percutaneous Nerve Evaluation Versus Staged Sacral Nerve Stimulation for Fecal Incontinence.

Sacral neuromodulation using a 2-staged approach is an established therapy for fecal incontinence. Office-based percutaneous nerve evaluation is a less-invasive alternative to the stage 1 procedure but is seldom used in the evaluation of patients with fecal incontinence. The aim of this study was to determine the clinical success of percutaneous nerve evaluation versus a staged approach. This was a retrospective review of a prospectively maintained, single-institution database of patients treated with sacral neuromodulation for fecal incontinence. This study was conducted at a single academic medical center. Eighty-six consecutive patients were treated with sacral neuromodulation for fecal incontinence. Percutaneous nerve evaluation was compared with a staged approach. The primary outcome measured was the proportion of patients progressing to complete implantation based on >50% improvement in Wexner score during the testing phase. Percutaneous nerve evaluation was performed in 45 patients, whereas 41 underwent a staged approach. The mean baseline Wexner score did not differ between testing groups. Success was similar between the staged approach and percutaneous nerve evaluation (90.2% versus 82.2%; p = 0.36). The mean 3-month Wexner score was not significantly different between testing methods (4.4 versus 4.1; p = 0.74). However, infection was more likely to occur after the staged approach (10.5% versus 0.0%; p < 0.05). This study was limited by its retrospective nature and potential for selection bias. Percutaneous nerve evaluation offers a viable alternative to a staged approach in the evaluation of patients for sacral neuromodulation in the setting of fecal incontinence. Not only are success rates similar, but percutaneous nerve evaluation also has the benefit of limiting patients to 1 operating room visit and has lower rates of infection as compared with the traditional staged approach for sacral neuromodulation.

Sacral nerve stimulation for faecal incontinence: medium-term follow-up from a single institution.

Most studies on sacral nerve stimulation (SNS) are either single-centre with small numbers of patients or multi-centre studies. We present the medium-term follow-up results from a single centre for 127 patients undergoing SNS. Consecutive patients treated with SNS for faecal incontinence had preoperative baseline St Mark's continence scores, faecal incontinence quality of life (FIQL) measures and anorectal physiology studies. Follow-up was a postal questionnaire concerning continence, FIQL, patient-perceived change in bowel control (-5 to +5 where 0 is no change), overall satisfaction (0-10 visual analogue scale) and use of medications. A total of 166 patients underwent temporary nerve stimulation testing, of which 112 progressed to a permanent implantable pulse generator (IPG). Fifteen received an IPG without the testing phase, hence 127 patients in total. Fourteen had the IPG removed, four were deceased, leaving 109 for assessment; 91 (83%) responded to the survey. Mean follow-up was 2.7 years (range: 2 months-8.5 years). Mean baseline St Mark's continence score was 14.4, and mean follow-up score was 10.3 (P < 0.01). FIQL improved in all domains (P < 0.001). Patient-reported improved bowel control mean score was +3.2 (95% CI: 2.9, 3.55). Median satisfaction score was 8.0 (range: 0-10). Complications included 17 lead dislodgements, seven superficial infections, five infections requiring surgery and five repositioning of a rotated IPG. Thirty-two patients used loperamide and 34 used fibre supplements. In this observational study, limited by the absence of a placebo control group, SNS significantly improved continence and quality of life, and patient satisfaction was high.

Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?

The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients. Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up. Generator lifespan was measured according to the Kaplan-Meier method. Patients with a generator explanted/turned off before exhaustion were excluded. Morbidity of exhausted generator replacement and the outcome (Cleveland Clinic Florida Faecal Incontinence (CCF-FI) and Faecal Incontinence Quality of Life (FIQL) scores) were recorded. Of 135 patients with an implanted pulse generator, 112 (InterstimII 66) were included. Mean follow-up was 4.9 ± 2.8 years. The generator reached exhaustion in 29 (26%) cases. Overall median lifespan of an implanted pulse generator was approximately 9 years (95% CI 8-9.2). Interstim and InterstimII 25th percentile lifespan was 7.2 (CI 6.4-8.3) and 5 (CI 4-not reached) years, respectively. After exhaustion, generators were replaced, left in place or explanted in 23, 2 and 4 patients, respectively. Generator replacement was virtually uneventful. CCF-FI/FIQL scores remained unchanged after generator replacement (CCF-FI 8 ± 2 vs 7 ± 3; FIQL 3 ± 0.6 vs 3 ± 0.5; p = ns). In this study, the implanted pulse generator observed median lifespan was 9 years. After exhaustion, generators were safely and efficiently replaced. The study also gives insight into long-term needs and costs of sacral nerve stimulation (SNS) therapy.

Sacral nerve stimulation for faecal incontinence - efficacy confirmed from a two-centre prospectively maintained database.

Sacral nerve stimulation (SNS) has been recognised as an effective treatment for faecal incontinence. Many unresolved questions could be answered when comparing large data-series from different centres providing prospective data. To present data, from an international two-centre SNS prospective database (SNSPD) on functional outcome and management of surgical complications in patients treated with SNS for faecal incontinence. The SNSPD was designed in order to gather detailed pre- and perioperative information followed by a close follow-up in all patients undergoing SNS for bowel dysfunction. The SNSPD was open for inclusion of newly SNS implanted patients in May 2009, and closed on 31 December 2013. Two-centres Aarhus, Denmark, and Nantes, France, included and monitored all patients implanted due to bowel dysfunction according to database criteria. In total, 164 faecal incontinent patients with a median follow-up of 22 (range 1-50) months were implanted. The Wexner incontinence score improved from 15 (range, 3-20) at baseline to 9 (range, 0-20) at latest follow-up (P < 0.001) and VAS impact on daily life improved from 85.5 (range, 3-100) to 20 (range, 0-100) (P < 0.001). Additional surgical intervention was required in 19.5 % during follow-up. Repositioning of the pacemaker due to pain or migration was the most common complication in 12.1 %. Infections leading to explantation occurred in 3.0 %.

A review of sacral nerve stimulation for faecal incontinence following rectal surgery and radiotherapy.

Faecal incontinence may occur following rectal surgery and/or radiotherapy for rectal cancer. The aim of this paper was to review the evidence to support the use of sacral nerve stimulation (SNS) for patients with incontinence who had undergone rectal surgery or received rectal radiotherapy. A search was performed of PubMed, Medline and Embase. All studies which reported the outcome of SNS in patients who had undergone a rectal resection or radiotherapy were reviewed. The first report of SNS following rectal surgery was in 2002. Since then seven further studies have described its effect in patients who have undergone anterior resection or pelvic radiotherapy. The total number of patients was 57. All studies were single group series, which ranged in size from one to 15 patients. The follow-up ranged from 1 to 36 months. The success of peripheral nerve evaluation ranged from 47% to 100%. Permanent SNS improved the symptoms and in some studies this was reflected in improved quality of life. The wide variation of patient factors, operations performed, the dose of radiotherapy given and time from operation makes interpretation of the results difficult. Larger studies with better patient selection are needed to investigate the effect of SNS on incontinence following radiotherapy or rectal surgery.

Short-term Outcomes of a Randomized Pilot Trial of 2 Treatment Regimens of Transcutaneous Tibial Nerve Stimulation for Fecal Incontinence.

Fecal incontinence is a socially disabling condition that affects ≤15% of adults. Neuromodulatory treatments for fecal incontinence are now well established. Less invasive, cheaper, and more ambulatory forms of neuromodulation are under exploration. The purpose of this study was to assess the acceptability and safety of a new ambulatory tibial nerve stimulation device and to determine clinical effect size for 2 differing regimens of therapy. This was a randomized, investigator-blinded, parallel-arm, 6-week pilot trial. The study was conducted at 7 United Kingdom trial centers. Patients were initially reviewed in the trial center, with subsequent applications of the device performed in the patients home setting. A total of 43 eligible patients (38 women) who failed conservative management of fecal incontinence were included in the study. The study intervention involved twice-weekly, 1- versus 4-hour transcutaneous tibial nerve stimulation for 6 weeks (total of 12 treatments). Standard fecal incontinence outcome tools (bowel diary, symptom severity score, and generic quality-of-life instruments) were used to collect data at baseline and at 2 weeks posttreatment cessation. A total of 22 patients were randomly assigned to the 1-hour group and 21 to the 4-hour group. Improvements in fecal incontinence outcomes were observed for both groups, including median urge incontinence episodes per week at baseline and posttreatment (1-hour group 2.0 to 0.5 versus 4-hour group 4.0 to 1.0) and deferment time (1-hour group 2.0 to 2.0 minutes versus 4-hour group 0.5 to 5.0 minutes). Accompanying changes were observed in physical functioning domains of quality-of-life instruments. There were no adverse events, and the treatment was highly acceptable to patients. Limitations included the pilot design and lack of control arm in the study. Future trials would need to address these limitations. This pilot study provides evidence that transcutaneous tibial nerve stimulation with a new ambulatory device is safe and acceptable for the management of fecal incontinence. Additional study is warranted to investigate clinical effectiveness.

Sacral nerve stimulation for faecal incontinence and constipation in adults.

Sacral nerve stimulation for faecal incontinence and constipation in adults.