Grieving multiple losses: Experiences of intimacy and sexuality of people living with inflammatory bowel disease. A phenomenological study.

AIM: To explore patient experiences of intimacy and sexuality in those living with inflammatory bowel disease. DESIGN: An interpretative phenomenological study guided by van Manen's framework. Thematic analysis was conducted through interpretation and reflection on four existential domains: body, relationships, time and space. METHODS: Data were collected during 2019-2021 from 43 participants via face-to-face or telephone interviews, as well as anonymous collection of narratives submitted via Google Forms. RESULTS: Four themes were identified: Sexuality as lived incompleteness was the overarching theme representing the essence of the experiences of intimacy and sexuality. This theme covered the four main themes: Otherness of the body, Interrupted connectedness, Missing out on life fullness and Fragmented openness and each corresponded to an existential domain. Intimacy and sexuality are negatively affected by inflammatory bowel disease, with impact on quality of life. Patients experienced grieving multiple losses, from body image and control, to choice of partners and future opportunities. The four domains were difficult to separate and a close inter-relationship between each domain was acknowledged. CONCLUSIONS: A model was developed to draw new theoretical insights to understanding the relationship between sexual well-being and psycho-emotional distress similar to grief. IMPACT: First qualitative study to explore intimacy and sexuality experiences of those living with inflammatory bowel disease. Illness impact on sexuality has negative psycho-emotional implications as a result of losing the old self and capacity to have the desired relationships/sex life. A theoretical model was developed in an attempt to illustrate the close relationship of intimacy, sexuality and psycho-emotional well-being. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study design.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial.

AIM: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST). METHOD: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention. The inclusion criteria were age 18-70 years; attending specialist hospitals in England; self-reported constipation for >6 months; refractory to basic treatment. The main exclusions were secondary constipation and previous experience of the trial interventions. The primary outcome was the mean change in Patient Assessment of Constipation Quality of Life score at 6 months on intention to treat. The secondary outcomes were validated disease-specific and psychological questionnaires and cost-effectiveness (based on EQ-5D-5L). RESULTS: In all, 182 patients were randomized 3:3:2 (target 384): HT n = 68; HTBF n = 68; INVEST-guided treatment n = 46. All interventions had similar reductions (improvement) in the primary outcome at 6 months (approximately -0.8 points of a 4-point scale) with no statistically significant difference between HT and HTBF (-0.03 points; 95% CI -0.33 to 0.27; P = 0.85) or INVEST versus no-INVEST (0.22; -0.11 to 0.55; P = 0.19). Secondary outcomes showed a benefit for all interventions with no evidence of greater cost-effectiveness of HTBF or INVEST compared with HT. CONCLUSION: The results of the study at 6 months were inconclusive. However, with the caveat of under-recruitment and further attrition at 6 months, a simple, cheaper approach to intervention may be as clinically effective and more cost-effective than more complex and invasive approaches.

Interventions for fatigue in inflammatory bowel disease.

BACKGROUND: Inflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies. OBJECTIVES: To assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator. SEARCH METHODS: A systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies. SELECTION CRITERIA: Randomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used. MAIN RESULTS: We included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy). Electroacupuncture Fatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group. Cognitive behavioural therapy (CBT) and solution-focused therapy Compared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants). Physical activity advice One 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group. Pharmacological interventions Compared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence). Ferric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence) AUTHORS' CONCLUSIONS: The effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome.

Implementing advance care planning with community-dwelling frail elders requires a system-wide approach: An integrative review applying a behaviour change model.

BACKGROUND: Facilitating advance care planning with community-dwelling frail elders can be challenging. Notably, frail elders' vulnerability to sudden deterioration leads to uncertainty in recognising the timing and focus of advance care planning conversations. AIM: To understand how advance care planning can be better implemented for community-dwelling frail elders and to develop a conceptual model to underpin intervention development. DESIGN: A structured integrative review of relevant literature. DATA SOURCES: CINAHL, Embase, Ovid Medline, PsycINFO, Cochrane Library, and University of York Centre for Reviews and Dissemination. Further strategies included searching for policy and clinical documents, grey literature, and hand-searching reference lists. Literature was searched from 1990 until October 2018. RESULTS: From 3043 potential papers, 42 were included. Twenty-nine were empirical, six expert commentaries, four service improvements, two guidelines and one theoretical. Analysis revealed nine themes: education and training, personal ability, models, recognising triggers, resources, conversations on death and dying, living day to day, personal beliefs and experience, and relationality. CONCLUSION: Implementing advance care planning for frail elders requires a system-wide approach, including providing relevant resources and clarifying responsibilities. Early engagement is key for frail elders, as is a shift from the current advance care planning model focussed on future ceilings of care to one that promotes living well now alongside planning for the future. The proposed conceptual model can be used as a starting point for professionals, organisations and policymakers looking to improve advance care planning for frail elders.

Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT.

BACKGROUND: Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments. DESIGN: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. SETTING: The trial took place in 12 UK hospitals. PARTICIPANTS: PwMS who had 'bothersome' NBD. INTERVENTION: Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse. MAIN OUTCOME MEASURES: The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). RESULTS: A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, n = 99; intervention group, n = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% (n = 154) were female and 11% (n = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score -1.64, 95% confidence interval (CI) -3.32 to 0.04; p = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; p = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; p = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost-utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -0.002 quality-adjusted life-years (QALYs) (95% CI -0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. CONCLUSION: The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients. FUTURE WORK: Research is required to establish possible mechanisms of action and modes of massage delivery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN85007023 and NCT03166007. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 58. See the NIHR Journals Library website for further project information.

Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial.

BACKGROUND: Faecal incontinence (FI) is a substantial health problem with a prevalence of approximately 8% in community-dwelling populations. Sacral neuromodulation (SNM) is considered the first-line surgical treatment option in adults with FI in whom conservative therapies have failed. The clinical efficacy of SNM has never been rigorously determined in a trial setting and the underlying mechanism of action remains unclear. METHODS/DESIGN: The design encompasses a multicentre, randomised, double-blind crossover trial and cohort follow-up study. Ninety participants will be randomised to one of two groups (SNM/SHAM or SHAM/SNM) in an allocation ratio of 1:1. The main inclusion criteria will be adults aged 18-75 years meeting Rome III and ICI definitions of FI, who have failed non-surgical treatments to the UK standard, who have a minimum of eight FI episodes in a 4-week screening period, and who are clinically suitable for SNM. The primary objective is to estimate the clinical efficacy of sub-sensory SNM vs. SHAM at 32 weeks based on the primary outcome of frequency of FI episodes using a 4-week paper diary, using mixed Poisson regression analysis on the intention-to-treat principle. The study is powered (0.9) to detect a 30% reduction in frequency of FI episodes between sub-sensory SNM and SHAM stimulation over a 32-week crossover period. Secondary objectives include: measurement of established and new clinical outcomes after 1 year of therapy using new (2017 published) optimised therapy (with standardised SNM-lead placement); validation of new electronic outcome measures (events) and a device to record them, and identification of potential biological effects of SNM on underlying anorectal afferent neuronal pathophysiology (hypothesis: SNM leads to increased frequency of perceived transient anal sphincter relaxations; improved conscious sensation of defaecatory urge and cortical/subcortical changes in afferent responses to anorectal electrical stimulation (main techniques: high-resolution anorectal manometry and magnetoencephalography). DISCUSSION: This trial will determine clinical effect size for sub-sensory chronic electrical stimulation of the sacral innervation. It will provide experimental evidence of modifiable afferent neurophysiology that may aid future patient selection as well as a basic understanding of the pathophysiology of FI. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN98760715 . Registered on 15 September 2017.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial.

BACKGROUND: Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice. METHODS/DESIGN: A three-arm, parallel-group, multicentre randomised controlled trial. OBJECTIVES: to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience. HYPOTHESES: (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis. DISCUSSION: This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.

Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER - Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial.

BACKGROUND: Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50-80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain. METHODS/DESIGN: This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles. DISCUSSION: This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS. TRIAL REGISTRATION: ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.

Management of opioid-induced constipation.

Up to 40% of patients taking opioids develop constipation. Opioid-induced constipation (OIC) may limit the adequate dosing of opioids for pain relief and reduce quality of life. Health professionals must therefore inquire about bowel function in patients receiving opioids. The management of OIC includes carefully re-evaluating the necessity, type and dose of opioids at each visit. Lifestyle modification and alteration of aggravating factors, the use of simple laxatives and, when essential, the addition of newer laxatives or opioid antagonists (naloxone, naloxegol or methylnaltrexone) can be used to treat OIC. This review discusses the recent literature regarding the management of OIC and provides a rational approach to assessing and managing constipation in individuals receiving opioids.

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial).

BACKGROUND: Faecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted. OBJECTIVES: To assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed. DESIGN: Multicentre, parallel-arm, double-blind randomised (1 : 1) controlled trial. SETTING: Eighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders. PARTICIPANTS: Participants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention. INTERVENTIONS: PTNS was delivered via the Urgent(®) PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer's protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation. MAIN OUTCOME MEASURES: Outcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs). RESULTS: In total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28; p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta -2.3, 95% CI -4.2 to -0.3; p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark's Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported. CONCLUSIONS: PTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88559475. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial.

BACKGROUND: Percutaneous tibial nerve stimulation (PTNS) is a new ambulatory therapy for faecal incontinence. Data from case series suggest it has beneficial outcomes in 50-80% patients; however its effectiveness against sham electrical stimulation has not been investigated. We therefore aimed to assess the short-term efficacy of PTNS against sham electrical stimulation in adults with faecal incontinence. METHODS: We did a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial (CONtrol of Faecal Incontinence using Distal NeuromodulaTion [CONFIDeNT]) in 17 specialist hospital units in the UK that had the skills to manage patients with faecal incontinence. Eligible participants aged 18 years or older with substantial faecal incontinence for whom conservative treatments (such as dietary changes and pelvic floor exercises) had not worked, were randomly assigned (1:1) to receive either PTNS (via the Urgent PC neuromodulation system) or sham stimulation (via a transcutaneous electrical nerve stimulation machine to the lateral forefoot) once per week for 12 weeks. Randomisation was done with permuted block sizes of two, four, and six, and was stratified by sex and then by centre for women. Patients and outcome assessors were both masked to treatment allocation for the 14-week duration of the trial (but investigators giving the treatment were not masked). The primary outcome was a clinical response to treatment, which we defined as a 50% or greater reduction in episodes of faecal incontinence per week. We assessed this outcome after 12 treatment sessions, using data from patients' bowel diaries. Analysis was by intention to treat, and missing data were multiply imputed. This trial is registered with the ISRCTN registry, number 88559475, and is closed to new participants. FINDINGS: Between Jan 23, 2012, and Oct 31, 2013, we randomly assigned 227 eligible patients (of 373 screened) to receive either PTNS (n=115) or sham stimulation (n=112). 12 patients withdrew from the trial: seven from the PTNS group and five from the sham group (mainly because they could not commit to receiving treatment every week). Two patients (one in each group) withdrew because of an adverse event that was unrelated to treatment (exacerbation of fibromyalgia and rectal bleeding). 39 (38%) of 103 patients with full data from bowel diaries in the PTNS group had a 50% or greater reduction in the number of episodes of faecal incontinence per week compared with 32 (31%) of 102 patients in the sham group (adjusted odds ratio 1·28, 95% CI 0·72-2·28; p=0·396). No serious adverse events related to treatment were reported in the trial. Seven mild, related adverse events were reported in each treatment group, mainly pain at the needle site (four in PTNS, three in sham). INTERPRETATION: PTNS given for 12 weeks did not confer significant clinical benefit over sham electrical stimulation in the treatment of adults with faecal incontinence. Further studies are warranted to determine its efficacy in the long term, and in patient subgroups (ie, those with urgency). FUNDING: National Institute for Health Research.

Biofeedback for treatment of chronic idiopathic constipation in adults.

BACKGROUND: Biofeedback therapy has been used to treat the symptoms of people with chronic constipation referred to specialist services within secondary and tertiary care settings. However, different methods of biofeedback are used within different centres and the magnitude of suggested benefits and comparable effectiveness of different methods of biofeedback has yet to be established. OBJECTIVES: To determine the efficacy and safety of biofeedback for the treatment of chronic idiopathic (functional) constipation in adults. SEARCH METHODS: We searched the following databases from inception to 16 December 2013: CENTRAL, the Cochrane Complementary Medicine Field, the Cochrane IBD/FBD Review Group Specialized Register, MEDLINE, EMBASE, CINAHL, British Nursing Index, and PsychINFO. Hand searching of conference proceedings and the reference lists of relevant articles was also undertaken. SELECTION CRITERIA: All randomised trials evaluating biofeedback in adults with chronic idiopathic constipation were considered for inclusion. DATA COLLECTION AND ANALYSIS: The primary outcome was global or clinical improvement as defined by the included studies. Secondary outcomes included quality of life, and adverse events as defined by the included studies. Where possible, we calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for dichotomous outcomes and the mean difference (MD) and 95% CI for continuous outcomes. We assessed the methodological quality of included studies using the Cochrane risk of bias tool. The overall quality of the evidence supporting each outcome was assessed using the GRADE criteria. MAIN RESULTS: Seventeen eligible studies were identified with a total of 931 participants. Most participants had chronic constipation and dyssynergic defecation. Sixteen of the trials were at high risk of bias for blinding. Attrition bias (4 trials) and other potential bias (5 trials) was also noted. Due to differences between study populations, the heterogeneity of the different samples and large range of different outcome measures, meta-analysis was not possible. Different effect sizes were reported ranging from 40 to 100% of patients who received biofeedback improving following the intervention. While electromyograph (EMG) biofeedback was the most commonly used, there is a lack of evidence as to whether any one method of biofeedback is more effective than any other method of biofeedback. We found low or very low quality evidence that biofeedback is superior to oral diazepam, sham biofeedback and laxatives. One study (n = 60) found EMG biofeedback to be superior to oral diazepam. Seventy per cent (21/30) of biofeedback patients had improved constipation at three month follow-up compared to 23% (7/30) of diazepam patients (RR 3.00, 95% CI 1.51 to 5.98). One study compared manometry biofeedback to sham biofeedback or standard therapy consisting of diet, exercise and laxatives. The mean number of complete spontaneous bowel movements (CSBM) per week at three months was 4.6 in the biofeedback group compared to 2.8 in the sham biofeedback group (MD 1.80, 95% CI 1.25 to 2.35; 52 patients). The mean number of CSBM per week at three months was 4.6 in the biofeedback group compared to 1.9 in the standard care group (MD 2.70, 95% CI 1.99 to 3.41; 49 patients). Another study (n = 109) compared EMG biofeedback to conventional treatment with laxatives and dietary and lifestyle advice. This study found that at both 6 and 12 months 80% (43/54) of biofeedback patients reported clinical improvement compared to 22% (12/55) laxative-treated patients (RR 3.65, 95% CI 2.17 to 6.13). Some surgical procedures (partial division of puborectalis and stapled transanal rectal resection (STARR)) were reported to be superior to biofeedback, although with a high risk of adverse events in the surgical groups (wound infection, faecal incontinence, pain, and bleeding that required further surgical intervention). Successful treatment, defined as a decrease in the obstructed defecation score of > 50% at one year was reported in 33% (3/39) of EMG biofeedback patients compared to 82% (44/54) of STARR patients (RR 0.41, 95% CI 0.26 to 0.65). For the other study the mean constipation score at one year was 16.1 in the balloon sensory biofeedback group compared to 10.5 in the partial division of puborectalis surgery group (MD 5.60, 95% CI 4.67 to 6.53; 40 patients). Another study (n = 60) found no significant difference in efficacy did not demonstrate the superiority of a surgical intervention (posterior myomectomy of internal anal sphincter and puborectalis) over biofeedback. Conflicting results were found regarding the comparative effectiveness of biofeedback and botulinum toxin-A. One small study (48 participants) suggested that botulinum toxin-A injection may have short term benefits over biofeedback, but the relative effects of treatments were uncertain at one year follow-up. No adverse events were reported for biofeedback, although this was not specifically reported in the majority of studies. The results of all of these studies need to be interpreted with caution as GRADE analyses rated the overall quality of the evidence for the primary outcomes (i.e. clinical or global improvement as defined by the studies) as low or very low due to high risk of bias (i.e. open label studies, self-selection bias, incomplete outcome data, and baseline imbalance) and imprecision (i.e. sparse data). AUTHORS' CONCLUSIONS: Currently there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of biofeedback for the management of people with chronic constipation. We found low or very low quality evidence from single studies to support the effectiveness of biofeedback for the management of people with chronic constipation and dyssynergic defecation. However, the majority of trials are of poor methodological quality and subject to bias. Further well-designed randomised controlled trials with adequate sample sizes, validated outcome measures (especially patient reported outcome measures) and long-term follow-up are required to allow definitive conclusions to be drawn.

Management of faecal incontinence and constipation in adults with central neurological diseases.

BACKGROUND: People with central neurological disease or injury have a much higher risk of both faecal incontinence and constipation than the general population. There is often a fine line between the two symptoms, with any management intended to ameliorate one risking precipitating the other. Bowel problems are observed to be the cause of much anxiety and may reduce quality of life in these people. Current bowel management is largely empirical, with a limited research base. This is an update of a Cochrane review first published in 2001 and subsequently updated in 2003 and 2006. The review is relevant to individuals with any disease directly and chronically affecting the central nervous system (post-traumatic, degenerative, ischaemic or neoplastic), such as multiple sclerosis, spinal cord injury, cerebrovascular disease, Parkinson's disease and Alzheimer's disease. OBJECTIVES: To determine the effects of management strategies for faecal incontinence and constipation in people with a neurological disease or injury affecting the central nervous system. SEARCH METHODS: We searched the Cochrane Incontinence Group Trials Register (searched 8 June 2012), which includes searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In-Process as well as handsearching of journals and conference proceedings; and all reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials evaluating any type of conservative or surgical intervention for the management of faecal incontinence and constipation in people with central neurological disease or injury were selected. Specific therapies for the treatment of neurological diseases that indirectly affect bowel dysfunction were also considered. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed the risk of bias of eligible trials and independently extracted data from the included trials using a range of pre-specified outcome measures. MAIN RESULTS: Twenty trials involving 902 people were included. Oral medications There was evidence from individual small trials that people with Parkinson's disease had a statistically significant improvement in the number of bowel motions or successful bowel care routines per week when fibre (psyllium) (mean difference (MD) -2.2 bowel motions, 95% confidence interval (CI) -3.3 to -1.4) or oral laxative (isosmotic macrogol electrolyte solution) (MD 2.9 bowel motions per week, 95% CI 1.48 to 4.32) are used compared with placebo. One trial in people with spinal cord injury showed statistically significant improvement in total bowel care time comparing intramuscular neostigmine-glycopyrrolate (anticholinesterase plus an anticholinergic drug) with placebo (MD 23.3 minutes, 95% CI 4.68 to 41.92).Five studies reported the use of cisapride and tegaserod in people with spinal cord injuries or Parkinson's disease. These drugs have since been withdrawn from the market due to adverse effects; as they are no longer available they have been removed from this review. Rectal stimulants One small trial in people with spinal cord injuries compared two bisacodyl suppositories, one polyethylene glycol-based (PGB) and one hydrogenated vegetable oil-based (HVB). The trial found that the PGB bisacodyl suppository significantly reduced the mean defaecation period (PGB 20 minutes versus HVB 36 minutes, P < 0.03) and mean total time for bowel care (PGB 43 minutes versus HVB 74.5 minutes, P < 0.01) compared with the HVB bisacodyl suppository.Physical interventions There was evidence from one small trial with 31 participants that abdominal massage statistically improved the number of bowel motions in people who had a stroke compared with no massage (MD 1.7 bowel motions per week, 95% CI 2.22 to 1.18). A small feasibility trial including 30 individuals with multiple sclerosis also found evidence to support the use of abdominal massage. Constipation scores were statistically better with the abdominal massage during treatment although this was not supported by a change in outcome measures (for example the neurogenic bowel dysfunction score).One small trial in people with spinal cord injury showed statistically significant improvement in total bowel care time using electrical stimulation of abdominal muscles compared with no electrical stimulation (MD 29.3 minutes, 95% CI 7.35 to 51.25).There was evidence from one trial with a low risk of bias that for people with spinal cord injury transanal irrigation, compared against conservative bowel care, statistically improved constipation scores, neurogenic bowel dysfunction score, faecal incontinence score and total time for bowel care (MD 27.4 minutes, 95% CI 7.96 to 46.84). Patients were also more satisfied with this method.Other interventions In one trial in stroke patients, there appeared to be a short term benefit (less than six months) to patients in terms of the number of bowel motions per week with a one-off educational intervention from nurses (a structured nurse assessment leading to targeted education versus routine care), but this did not persist at 12 months. A trial in individuals with spinal cord injury found that a stepwise protocol did not reduce the need for oral laxatives and manual evacuation of stool.Finally, one further trial reported in abstract form showed that oral carbonated water (rather than tap water) improved constipation scores in people who had had a stroke. AUTHORS' CONCLUSIONS: There is still remarkably little research on this common and, to patients, very significant issue of bowel management. The available evidence is almost uniformly of low methodological quality. The clinical significance of some of the research findings presented here is difficult to interpret, not least because each intervention has only been addressed in individual trials, against control rather than compared against each other, and the interventions are very different from each other.There was very limited evidence from individual trials in favour of a bulk-forming laxative (psyllium), an isosmotic macrogol laxative, abdominal massage, electrical stimulation and an anticholinesterase-anticholinergic drug combination (neostigmine-glycopyrrolate) compared to no treatment or controls. There was also evidence in favour of transanal irrigation (compared to conservative management), oral carbonated (rather than tap) water and abdominal massage with lifestyle advice (compared to lifestyle advice alone). However, these findings need to be confirmed by larger well-designed controlled trials which should include evaluation of the acceptability of the intervention to patients and the effect on their quality of life.

Management of faecal incontinence and constipation in adults with central neurological diseases.

BACKGROUND: People with central neurological disease or injury have a much higher risk of both faecal incontinence and constipation than the general population. There is often a fine line between the two symptoms, with any management intended to ameliorate one risking precipitating the other. Bowel problems are observed to be the cause of much anxiety and may reduce quality of life in these people. Current bowel management is largely empirical, with a limited research base. This is an update of a Cochrane review first published in 2001 and subsequently updated in 2003 and 2006. The review is relevant to individuals with any disease directly and chronically affecting the central nervous system (post-traumatic, degenerative, ischaemic or neoplastic), such as multiple sclerosis, spinal cord injury, cerebrovascular disease, Parkinson's disease and Alzheimer's disease. OBJECTIVES: To determine the effects of management strategies for faecal incontinence and constipation in people with a neurological disease or injury affecting the central nervous system. SEARCH METHODS: We searched the Cochrane Incontinence Group Trials Register (searched 8 June 2012), which includes searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In-Process as well as handsearching of journals and conference proceedings; and all reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials evaluating any type of conservative or surgical intervention for the management of faecal incontinence and constipation in people with central neurological disease or injury were selected. Specific therapies for the treatment of neurological diseases that indirectly affect bowel dysfunction were also considered. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias of eligible trials and independently extracted data from the included trials using a range of pre-specified outcome measures. MAIN RESULTS: Twenty trials involving 902 people were included.Oral medicationsThere was evidence from individual small trials that people with Parkinson's disease had a statistically significant improvement in the number of bowel motions or successful bowel care routines per week when fibre (psyllium) (mean difference (MD) -2.2 bowel motions, 95% confidence interval (CI) -3.3 to -1.4) or oral laxative (isosmotic macrogol electrolyte solution) (MD 2.9 bowel motions per week, 95% CI 1.48 to 4.32) are used compared with placebo. One trial in people with spinal cord injury showed statistically significant improvement in total bowel care time comparing intramuscular neostigmine-glycopyrrolate (anticholinesterase plus an anticholinergic drug) with placebo (MD 23.3 minutes, 95% CI 4.68 to 41.92).Five studies reported the use of cisapride and tegaserod in people with spinal cord injuries or Parkinson's disease. These drugs have since been withdrawn from the market due to adverse effects; as they are no longer available they have been removed from this review.Rectal stimulantsOne small trial in people with spinal cord injuries compared two bisacodyl suppositories, one polyethylene glycol-based (PGB) and one hydrogenated vegetable oil-based (HVB). The trial found that the PGB bisacodyl suppository significantly reduced the mean defaecation period (PGB 20 minutes versus HVB 36 minutes, P < 0.03) and mean total time for bowel care (PGB 43 minutes versus HVB 74.5 minutes, P < 0.01) compared with the HVB bisacodyl suppository.Physical interventionsThere was evidence from one small trial with 31 participants that abdominal massage statistically improved the number of bowel motions in people who had a stroke compared with no massage (MD 1.7 bowel motions per week, 95% CI 2.22 to 1.18). A small feasibility trial including 30 individuals with multiple sclerosis also found evidence to support the use of abdominal massage. Constipation scores were statistically better with the abdominal massage during treatment although this was not supported by a change in outcome measures (for example the neurogenic bowel dysfunction score).One small trial in people with spinal cord injury showed statistically significant improvement in total bowel care time using electrical stimulation of abdominal muscles compared with no electrical stimulation (MD 29.3 minutes, 95% CI 7.35 to 51.25).There was evidence from one trial with a low risk of bias that for people with spinal cord injury transanal irrigation, compared against conservative bowel care, statistically improved constipation scores, neurogenic bowel dysfunction score, faecal incontinence score and total time for bowel care (MD 27.4 minutes, 95% CI 7.96 to 46.84). Patients were also more satisfied with this method.Other interventionsIn one trial in stroke patients, there appeared to be a short term benefit (less than six months) to patients in terms of the number of bowel motions per week with a one-off educational intervention from nurses (a structured nurse assessment leading to targeted education versus routine care), but this did not persist at 12 months. A trial in individuals with spinal cord injury found that a stepwise protocol did not reduce the need for oral laxatives and manual evacuation of stool.Finally, one further trial reported in abstract form showed that oral carbonated water (rather than tap water) improved constipation scores in people who had had a stroke. AUTHORS' CONCLUSIONS: There is still remarkably little research on this common and, to patients, very significant issue of bowel management. The available evidence is almost uniformly of low methodological quality. The clinical significance of some of the research findings presented here is difficult to interpret, not least because each intervention has only been addressed in individual trials, against control rather than compared against each other, and the interventions are very different from each other.There was very limited evidence from individual trials in favour of a bulk-forming laxative (psyllium), an isosmotic macrogol laxative, abdominal massage, electrical stimulation and an anticholinesterase-anticholinergic drug combination (neostigmine-glycopyrrolate) compared to no treatment or controls. There was also evidence in favour of transanal irrigation (compared to conservative management), oral carbonated (rather than tap) water and abdominal massage with lifestyle advice (compared to lifestyle advice alone). However, these findings need to be confirmed by larger well-designed controlled trials which should include evaluation of the acceptability of the intervention to patients and the effect on their quality of life.

Managing passive incontinence and incomplete evacuation.

Both passive faecal incontinence and evacuation difficulty are distressing and demoralising conditions, resulting in physical and psychological problems including social restrictions, loss of self-esteem, altered body image and loss of skin integrity. Conservative management and biofeedback therapy has been shown to help most patients with faecal incontinence and evacuation difficulty by creating a manageable situation that can significantly improve quality of life. However, some patients may not improve their symptoms and require alternative measures. This article reports an audit of the use of the Qufora mini irrigation system in 50 patients (48 female, 2 male) with passive faecal incontinence and/or evacuation difficulty who had failed to respond to conventional biofeedback. Seventy percent found the irrigation comfortable and 74% rated the system as good or acceptable. Two-thirds believed symptoms were improved and would wish to continue using the system. Prospective studies are needed to confirm which patients are most suitable and respond well to the irrigation.

A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care.

OBJECTIVE: To assess preliminary effects of a program of transcutaneous posterior tibial nerve stimulation (TPTNS) on lower urinary tract symptoms and number of episodes of urinary and fecal incontinence in older adults in residential care homes and the feasibility of a full-scale randomized trial. DESIGN: Pilot randomized single-blind, placebo-controlled trial. SETTING: Seven residential care homes and 3 sheltered accommodation complexes in the United Kingdom. PARTICIPANTS: Thirty care home residents aged 65 and older with urinary or bowel symptoms and/or incontinence. INTERVENTIONS: Twelve 30-minute sessions of TPTNS or sham stimulation (placebo). MEASUREMENTS: Lower urinary tract symptoms using American Urological Society Symptom Index, urinary incontinence using International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), postvoid residual urine volumes using portable bladder scanning, bowel symptoms and fecal incontinence using selected ICIQ questions. RESULTS: Total American Urological Society Symptom Index scores improved, showing a median reduction of 7 (interquartile range [IQR] -8 to -3) in the TPTNS group and a median increase in the sham stimulation (placebo) group of 1 (IQR -1 to 4) (Mann-Whitney U 16.5000, Z -3.742, P < .001). Total ICIQ-SF scores improved by a median of 2 (IQR -6 to 0) in the TPTNS group and 0 points (IQR -3 to 3) in the sham stimulation group (Mann-Whitney U 65.000, Z -1.508, P = .132). Significant reduction was found in postvoid residual urine of 55 mL in the TPTNS group (t = -2.215, df 11.338, P = .048). Bowel urgency improved in 27% of the TPTNS group compared with 8% of the sham group (χ(2) 2.395, df 2, P > .302), fecal leakage improved in 47% of the TPTNS group compared with 23% of the sham group (χ(2) 4.480, df 2, P > .106); however, these differences were not significant. No adverse effects were reported by older adults or care staff. CONCLUSION: TPTNS is safe and acceptable with evidence of potential benefit for bladder and bowel dysfunction in older male and female residents of care homes. Data support the feasibility of a substantive trial of TPTNS in this population.

Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults.

BACKGROUND: Faecal incontinence is a particularly embarrassing and distressing condition with significant medical, social and economic implications. Anal sphincter exercises (pelvic floor muscle training) and biofeedback therapy have been used to treat the symptoms of people with faecal incontinence. However, standards of treatment are still lacking and the magnitude of alleged benefits has yet to be established. OBJECTIVES: To determine the effects of biofeedback and/or anal sphincter exercises/pelvic floor muscle training for the treatment of faecal incontinence in adults. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 24 January 2012) which contains trials from searching CENTRAL, MEDLINE and handsearching of conference proceedings; and the reference lists of relevant articles. SELECTION CRITERIA: All randomised or quasi-randomised trials evaluating biofeedback and/or anal sphincter exercises in adults with faecal incontinence. DATA COLLECTION AND ANALYSIS: Two review authors assessed the risk of bias of eligible trials and two review authors independently extracted data from the included trials. A wide range of outcome measures were considered. MAIN RESULTS: Twenty one eligible studies were identified with a total of 1525 participants. About half of the trials had low risk of bias for randomisation and allocation concealment.One small trial showed that biofeedback plus exercises was better than exercises alone (RR for failing to achieve full continence 0.70, 95% CI 0.52 to 0.94).One small trial showed that adding biofeedback to electrical stimulation was better than electrical stimulation alone (RR for failing to achieve full continence 0.47, 95% CI 0.33 to 0.65).The combined data of two trials showed that the number of people failing to achieve full continence was significantly lower when electrical stimulation was added to biofeedback compared against biofeedback alone (RR 0.60, 95% CI 0.46 to 0.78).Sacral nerve stimulation was better than conservative management which included biofeedback and PFMT (at 12 months the incontinence episodes were significantly fewer with sacral nerve stimulation (MD 6.30, 95% CI 2.26 to 10.34).There was not enough evidence as to whether there was a difference in outcome between any method of biofeedback or exercises. There are suggestions that rectal volume discrimination training improves continence more than sham training. Further conclusions are not warranted from the available data. AUTHORS' CONCLUSIONS: The limited number of identified trials together with methodological weaknesses of many do not allow a definitive assessment of the role of anal sphincter exercises and biofeedback therapy in the management of people with faecal incontinence. We found some evidence that biofeedback and electrical stimulation may enhance the outcome of treatment compared to electrical stimulation alone or exercises alone. Exercises appear to be less effective than an implanted sacral nerve stimulator. While there is a suggestion that some elements of biofeedback therapy and sphincter exercises may have a therapeutic effect, this is not certain. Larger well-designed trials are needed to enable safe conclusions.