Simple water-based tacrolimus enemas for refractory proctitis.

BACKGROUND AND AIMS: Rectal ulcerative colitis (UC) and Crohn's disease (CD) often do not respond to conventional therapies. Oral and suppository tacrolimus are effective but often poorly tolerated or are complex to formulate. Tacrolimus is topically active, water soluble, and has minimal systemic toxicity when administered rectally; we therefore tested a simple tap water-based enema formulation. METHODS: Tacrolimus powder from 1 mg capsules and tap water in a 60 mL syringe were delivered rectally. The primary end-point was endoscopic response (UC: MAYO score reduction by one point; CD: improvement in ulcer number and severity). Secondary end-points included endoscopic remission, clinical response, stool frequency, and rectal bleeding. RESULTS: Seventeen patients [12 UC, five CD, nine female, median age 31 years] with refractory rectal disease were treated. The majority of patients had failed immunosuppressive therapy [88% thiopurine; 71% biologic therapy]. Initial enemas included 1-4 mg tacrolimus daily and 1-3 mg tacrolimus maintenance three times a week for a median of 20 weeks (range 3-204). Concomitant thiopurine or biologic therapy continued. 94% tolerated therapy. Of 12 UC patients, eight (67%) achieved endoscopic remission, one further patient achieved endoscopic response, and median partial MAYO scores decreased (pre:4 vs. post:2; P = 0.010). Of five CD patients, three (60%) achieved endoscopic response, two (40%) endoscopic remission, and three (60%) clinical response. Stool frequency, rectal bleeding, and C-reactive protein levels improved. Strictures became endoscopically passable in all four affected patients. No major adverse events were reported, and four patients had disease flare. CONCLUSIONS: Tacrolimus enemas are easy to prepare, well tolerated, effective, and safe. They should be included in the treatment armamentarium for inflammatory bowel disease-related refractory proctitis.

Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial.

BACKGROUND: Functional gastrointestinal disorders are common and costly to the health-care system. Most specialist care is provided by a gastroenterologist, but only a minority of patients have improvement in symptoms. Although they have proven to be effective, psychological, behavioural, and dietary therapies are not provided routinely. We aimed to compare the outcome of gastroenterologist-only standard care with multidisciplinary care. METHODS: In an open-label, single-centre, pragmatic trial, consecutive new referrals of eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders were randomly assigned (1:2) to receive gastroenterologist-only standard care or multidisciplinary clinic care. The multidisciplinary clinic included gastroenterologists, dietitians, gut-focused hypnotherapists, psychiatrists, and behavioural (biofeedback) physiotherapists. Randomisation was stratified by Rome IV disorder and whether referred from gastroenterology or colorectal clinic. Outcomes were assessed at clinic discharge or 9 months after the initial visit. The primary outcome was a score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement. Modified intention-to-treat analysis included all patients who attended at least one clinic visit and who had answered the primary outcome question. This study is registered with ClinicalTrials.gov, NCT03078634. FINDINGS: Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188 were randomly assigned to receive either standard care (n=65) or multidisciplinary care (n=123). 144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women. 61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians. 26 (57%) patients in the standard-care group and 82 (84%) patients in the multidisciplinary-care group had global symptom improvement (risk ratio 1·50 [95% CI 1·13-1·93]; p=0·00045). 29 (63%) patients in the standard-care group and 81 (83%) patients in the multidisciplinary-care group had adequate relief of symptoms in the past 7 days (p=0·010). Patients in the multidisciplinary-care group were more likely to experience a 50% or higher reduction in all Gastrointestinal Symptom Severity Index symptom clusters than were patients in the standard-care group. Of the patients with irritable bowel syndrome, a 50-point or higher reduction in IBS-SSS occurred in 10 (38%) of 26 patients in the standard care group compared with 39 (66%) of 59 patients in the multidisciplinary-care group (p=0·017). Of the patients with functional dyspepsia, a 50% reduction in the Nepean Dyspepsia Index was noted in three (11%) of 11 patients in the standard-care group and in 13 (46%) of 28 in the multidisciplinary-care group (p=0·47). After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087). The eight SF-36 scales did not differ between the groups at discharge. After treatment, median Somatic Symptom Scale-8 score was higher in the standard-care group than in the multidisciplinary-care group (10 [IQR 7-7] vs 9 [5-13]; p=0·082). Cost per successful outcome was higher in the standard-care group than the multidisciplinary-care group. INTERPRETATION: Integrated multidisciplinary clinical care appears to be superior to gastroenterologist-only care in relation to symptoms, specific functional disorders, psychological state, quality of life, and cost of care for the treatment of functional gastrointestinal disorders. Consideration should be given to providing multidisciplinary care for patients with a functional gastrointestinal disorder. FUNDING: None.

Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol.

BACKGROUND: Functional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders. METHODS: The "MANTRA" (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist ('biofeedback') and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures. DISCUSSION: There have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders. TRIAL REGISTRATION NUMBER: Clinicaltrials.govNCT03078634 Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017. Ethics and Dissemination: Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences. Protocol version 1.2.

Long-term outcome of sacral neuromodulation for chronic refractory constipation.

PURPOSE: Sacral neuromodulation has been reported as a treatment for severe idiopathic constipation. This study aimed to evaluate the long-term effects of sacral neuromodulation by following patients who participated in a prospective, open-label, multicentre study up to 5 years. METHODS: Patients were followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months. Symptoms and quality of life were assessed using bowel diary, the Cleveland Clinic constipation score and the Short Form-36 quality-of-life scale. RESULTS: Sixty-two patients (7 male, median age 40 years) underwent test stimulation, and 45 proceeded to permanent implantation. Twenty-seven patients exited the study (7 withdrawn consent, 7 loss of efficacy, 6 site-specific reasons, 4 withdrew other reasons, 2 lost to follow-up, 1 prior to follow-up). Eighteen patients (29%) attended 60-month follow-up. In 10 patients who submitted bowel diary, their improvement of symptoms was sustained: the number of defecations per week (4.1 ± 3.7 vs 8.1 ± 3.4, mean ± standard deviation, p < 0.001, baseline vs 60 months) and sensation of incomplete emptying (0.8 ± 0.3 vs 0.2 ± 0.1, p = 0.002). In 14 patients (23%) with Cleveland Clinic constipation score, improvement was sustained at 60 months [17.9 ± 4.4 (baseline) to 10.4 ± 4.1, p < 0.001]. Some 103 device-related adverse events were reported in 27 (61%). CONCLUSION: Benefit from sacral neuromodulation in the long-term was observed in a small minority of patients with intractable constipation. The results should be interpreted with caution given the high dropout and complication rate during the follow-up period.

A Controlled Study of a Group Mindfulness Intervention for Individuals Living With Inflammatory Bowel Disease.

BACKGROUND: This study aimed to evaluate the feasibility, acceptability, and effectiveness of a mindfulness-based intervention for patients with inflammatory bowel disease (MI-IBD). DESIGN: Treatment-as-usual control versus mindfulness-based stress reduction intervention. METHODS: Sixty patients participated in either the MI-IBD (n = 33) or treatment-as-usual group (n = 27) conditions. The MI-IBD consisted of an 8-week mindfulness-based stress reduction training group. Outcome measures were administered at baseline (before intervention), immediately after intervention, and 6 months after intervention. Primary outcomes included measures of quality of life, psychological distress (depression and anxiety), and mindfulness. Data for MI-IBD group participants also included weekly attendance, daily minutes meditated, and satisfaction with the program. RESULTS: There were no baseline differences between intervention and control groups on demographic variables or inflammatory bowel disease severity. Compared with the control group, the MI-IBD group reported significantly greater improvements in anxiety, quality of life, and mindfulness at after intervention, with reduction in depression and improvements in quality of life and mindfulness maintained at 6 months after intervention. CONCLUSIONS: Results demonstrate the feasibility, acceptability, and efficacy of a mindfulness intervention for patients with inflammatory bowel disease, with medium-to-large effects on psychological distress, quality of life, and mindfulness.

Gastroenterologist perceptions of faecal microbiota transplantation.

AIM: To explore gastroenterologist perceptions towards and experience with faecal microbiota transplantation (FMT). METHODS: A questionnaire survey consisting of 17 questions was created to assess gastroenterologists' attitude towards and experience with FMT. This was anonymously distributed in hard copy format amongst attendees at gastroenterology meetings in Australia between October 2013 and April 2014. Basic descriptive statistical analyses were performed. RESULTS: Fifty-two clinicians participated. Twenty one percent had previously referred patients for FMT, 8% more than once. Ninety percent would refer patients with Clostridium difficile infection (CDI) for FMT if easily available, 37% for ulcerative colitis, 13% for Crohn's disease and 6% for irritable bowel syndrome. Six percent would not refer any indication, including recurrent CDI. Eighty-six percent would enroll patients in FMT clinical trials. Thirty-seven percent considered the optimal mode of FMT administration transcolonoscopic, 17% nasoduodenal, 13% enema and 8% oral capsule. The greatest concerns regarding FMT were: 42% lack of evidence, 12% infection risk, 10% non infectious adverse effects/lack of safety data, 10% aesthetic, 10% lack of efficacy, 4% disease exacerbation, and 2% inappropriate use; 6% had no concerns. Seventy seven percent believed there is a lack of accessibility while 52% had an interest in learning how to provide FMT. Only 6% offered FMT at their institution. CONCLUSION: Despite general enthusiasm, most gastroenterologists have limited experience with, or access to, FMT. The greatest concerns were lack of supportive evidence and safety issues. However a significant proportion would refer indications other than CDI for FMT despite insufficient evidence. These data provide guidance on where education and training are required.

Prevalence of mental health disorders in inflammatory bowel disease: an Australian outpatient cohort.

BACKGROUND: This study aimed to characterize prevalence of anxiety and depressive conditions and uptake of mental health services in an Australian inflammatory bowel disease (IBD) outpatient setting. METHODS: Eighty-one IBD patients (39 males, mean age 35 years) attending a tertiary hospital IBD outpatient clinic participated in this study. Disease severity was evaluated according to the Manitoba Index. Diagnosis of an anxiety or depressive condition was based upon the Mini-International Neuropsychiatric Interview and the Hospital Anxiety and Depression Scale. RESULTS: Based on Hospital Anxiety and Depression Scale subscale scores >8 and meeting Mini-International Neuropsychiatric Interview criteria, 16 (19.8%) participants had at least one anxiety condition, while nine (11.1%) had a depressive disorder present. Active IBD status was associated with higher prevalence rates across all anxiety and depressive conditions. Generalized anxiety was the most common (12 participants, 14.8%) anxiety condition, and major depressive disorder (recurrent) was the most common depressive condition reported (five participants, 6.2%). Seventeen participants (21%) reported currently seeking help for mental health issues while 12.4% were identified has having at least one psychological condition but not seeking treatment. CONCLUSION: We conclude that rates of anxiety and depression are high in this cohort, and that IBD-focused psychological services should be a key component of any holistic IBD service, especially for those identified as having active IBD.

Pudendal nerve stimulation for bowel dysfunction in complete cauda equina syndrome.

OBJECTIVE: Pudendal nerve stimulation (PNS) aims to maximize afferent or efferent stimulation from the sacral plexus. BACKGROUND: We hypothesized this may be a promising new treatment for patients with bowel dysfunction in complete cauda equina syndrome (CES). METHODS: Thirteen patients with complete CES [8 constipation predominant (group 1) and 5 incontinence predominant (group 2)] had a 3-week trial of PNS. Patients who showed a 50% or more improvement in symptoms during the trial phase proceeded to permanent neurostimulator implantation. RESULTS: Five (63%) of the 8 patients in group 1 showed a 50% or more improvement in bowel symptoms during the trial phase and were permanently implanted. The mean Cleveland Clinic constipation score, sense of incomplete evacuation (%), and straining during defecation (%) improved from 17 ± 3.2 to 10 ± 4.5, 94 ± 18% to 30 ± 35%, and 81 ± 23% to 44 ± 38%, respectively. All 5 patients in group 2 showed a 50% or more reduction in incontinent episodes during the trial phase. The mean St Mark's score, ability to defer defecation, and the number of incontinent episodes per week improved from 18 ± 1.0 to 3.8 ± 2.5, 2.2 ± 1.8 to 11 ± 5.5 minutes, and 9.4 ± 10.7 to 0.4 ± 0.5 episodes, respectively, per week. During a median follow-up of 12 (10-22) months of permanent implantation, one patient lost efficacy at 6 months due to lead migration and another required removal and reimplantation of the neurostimulator due to wound infection. CONCLUSIONS: PNS is an effective treatment in the short term for bowel dysfunction in some patients with complete CES.

Sacral nerve stimulation for intractable constipation.

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. Clinical Trial Number NCT00200005.

Sacral nerve stimulation for the treatment of faecal incontinence related to dysfunction of the internal anal sphincter.

PURPOSE: 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. METHODS: Nine patients (seven women, median age 44 years, range 39-62 years), with a history of obstetric or iatrogenic anal sphincter trauma, underwent a trial of SNS. All had passive faecal incontinence, low resting anal sphincter pressure and full thickness IAS muscle disruption of greater than 30 degrees radial extent. The effect of SNS on symptoms was measured by a bowel habit diary and validated questionnaires used to assess impact on quality of life. RESULTS: Eight (89%) patients benefited from temporary stimulation and proceeded to permanent device implantation. Follow-up was at a mean of 46 months (range 2-81). Faecal incontinence decreased from a mean (SD) of 9.9 (10.9) to 1.0 (2.4) episodes per week (p = 0.031), and soiling decreased from 6.1 (1.6) to 1.7 (2.4) episodes per week (p = 0.031), with chronic stimulation. At latest follow-up, three patients had no incontinence, three patients had episodes of minor soiling only, one patient had >75% reduction of incontinent episodes, and two patients remained incontinent. CONCLUSIONS: Sacral nerve stimulation is effective in treating faecal incontinence related to a structurally and functionally abnormal internal anal sphincter. Treatment should not be refused on the basis of IAS disruption.

Comparison of clinical outcome between open and percutaneous lead insertion for permanent sacral nerve neurostimulation for the treatment of fecal incontinence.

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.

Therapeutic strategies for the management of ulcerative colitis.

Induction and maintenance of remission, mucosal healing, the avoidance of surgical intervention, and decreasing the likelihood of cancer developing are the primary therapeutic goals in ulcerative colitis (UC). For the traditional therapies, 5-aminosalicylic acid (including mesalamine), corticosteroids, and thiopurines (azathioprine and mercaptopurine), there are major changes evolving in terms of formulation, patterns of use, and appreciation of long-term benefits and toxicities. The calcineurin inhibitors cyclosporin and tacrolimus, and infliximab, have recently defined, well-established roles. Preliminary supportive evidence is emerging in relation to novel antiinflammatory molecules such as curcumin, manipulation of the bacterial flora, enhancement of the mucosal barrier, and direct epithelial restoration. For patients in whom the disease is resistant to standard simple therapies, strategies are required to integrate these developing and new therapies into clinical practice. This review aims to highlight the evidence supporting new patterns of use of existing therapies and new therapies, and to devise therapeutic pathways that incorporate these new treatments. We propose how treatment might be optimized to improve the outcome in patients with mild-to-moderately active UC, chronic active UC, resistant proctitis, and fulminant UC.

The effect of Khat (Catha edulis) as an appetite suppressant is independent of ghrelin and PYY secretion.

BACKGROUND: The leaves of the khat plant (Catha edulis) are chewed for their pleasurable effects. Chewing releases cathinone which may decrease appetite through an unknown mechanism. Levels of the peptide ghrelin increase with hunger and decrease immediately post-prandially, while peptide YY is released following a meal. We hypothesised that the anorexigenic effects of khat may be mediated through changes in these hormones. MATERIALS AND METHODS: Six habitual khat chewers attended on two separate occasions. For a period of 3h they chewed either khat leaves or lettuce. Blood pressure (BP) and pulse rate (PR) were monitored throughout, as were subjective assessments of hunger and fullness. Plasma samples were analysed for cathinone, ghrelin and PYY levels. RESULTS: Chewing khat significantly decreased subjective feelings of hunger and increased fullness (p<0.05) but had no effect on ghrelin and PYY levels. Khat led to an increase in cathinone levels as well as an increase in BP and PR. Cathinone levels correlated positively with fullness and pulse rate and negatively with hunger. CONCLUSIONS: Chewing khat decreases subjective feelings of hunger and increases systemic sympathetic tone, but has no effect on ghrelin and PYY levels. We conclude that the anorexigenic effect of khat may be secondary to central mechanisms mediated via cathinone.

Sacral nerve stimulation for fecal incontinence related to obstetric anal sphincter damage.

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 with de novo external anal sphincter defects or defects after unsuccessful previous external anal sphincter repair, although numbers remain small.

Does the St. Mark's incontinence score reflect patients' perceptions? A review of 390 patients.

PURPOSE: The St. Mark's incontinence score is widely used to evaluate the severity of fecal incontinence. It is unknown to what extent such scores relate to patients' perceptions about their condition. The primary goal of this study was to assess this correlation. Secondary goals were to evaluate the relationship between different types of incontinence, age, gender, and the continence score and to assess the sensitivity of St. Mark's incontinence score to a change in patients' perception and outcome evaluation after treatment. METHODS: Patients' subjective perception of bowel control (using a 0-10 scale) and St. Mark's incontinence score for 390 patients were reviewed. Change in the score was documented for 131 patients who underwent biofeedback treatment and compared with patients' outcome evaluation. RESULTS: There was a moderate correlation between patients' perception of bowel control and the St. Mark's incontinence score (r = -0.55; P < 0.001). The correlation was maintained, regardless of type of incontinence (r = -0.48 to -0.55), age (60 years: r = -0.58; P < 0.001) or gender (male: r = -0.48; female: r = -0.53; P < 0.001) of patients. St. Mark's incontinence score was sensitive to a change in patients' subjective evaluation after the treatment. CONCLUSIONS: The St. Mark's incontinence score correlates moderately well with patients' subjective perception and is reliable regardless of the type of incontinence, patients' age, or gender. It is suitable for the severity assessment of fecal incontinence and the evaluation of a treatment outcome.

Permanent sacral nerve stimulation for treatment of functional anorectal pain: report of a case.

PURPOSE: 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. METHODS: A 56-year-old, female subject with an 18-month history of intermittent severe anorectal pain, in the absence of any evacuatory disorder or gross pathology, underwent temporary then subsequent permanent sacral nerve stimulation. Treatment efficacy was measured by verbal pain scores obtained at baseline, during screening, after screening, and subsequent follow-up. RESULTS: Temporary sacral nerve stimulation of the left S3 root (3-5 V; 14 Hz; 210 microsec) resulted in total alleviation of the patient's symptoms. A verbal pain score of 10/10 preoperatively was reduced to 0/10 with no adverse effects from stimulation. On completing the trial evaluation, the symptoms of pain returned with a verbal pain score of 10/10. A permanent pulse generator was implanted with a Medtronic 3093 quadripolar electrode lead, placed in the left S3 foramen. Results of chronic stimulation showed that pain symptoms were again abolished with no recurrence of symptoms seen at one-year follow-up (1.3 V; 14 Hz; 210 microsec). CONCLUSIONS: Sacral nerve stimulation may be of benefit in the treatment of functional anorectal pain resistant to conventional treatments. The mechanism of action is not known. Further prospective evaluation of a series of patients is required using pain scoring, quality of life, and psychologic assessment to aid selection.

Randomized, controlled trial of anal electrical stimulation for fecal incontinence.

PURPOSE: Anal electric stimulation has been described as effective for fecal incontinence in several case series, but no study has addressed possible mechanism of benefit. We wished to examine whether anal electric stimulation, using an anal probe electrode, used on a daily basis at home for eight weeks, in the absence of any adjunctive exercises or advice, would improve symptoms of fecal incontinence and anal sphincter pressures when compared with "sham" electric stimulation. METHODS: Ninety patients (9 males, 81 females), with median age of 55 (range, 30-77) years were randomized, 47 to active anal stimulation at 35 Hz and 43 to "sham" stimulation at 1 Hz. Outcome measures included a one-week bowel diary, symptom questionnaire, manometry, and patients' evaluation of outcome. RESULTS: Seventy patients completed the study. On an intention-to-treat analysis, there was no difference between the two groups on any of the outcome measures after eight weeks. Of those who completed stimulation, 44 (63 percent) felt the stimulation had improved their continence. Those with intact anal sphincters were not likely to rate their change more positively than those with sphincter disruption (P=0.71). Median patient rating of bowel control increased from 3 of 10 before stimulation to 5 of 10 after stimulation (P=0.001). CONCLUSIONS: Eight weeks of anal electric stimulation was rated by patients as having improved their bowel control to a modest extent. There was no statistically significant difference detected between the groups, suggesting that 1 Hz was as effective as 35 Hz. This raises the possibility that the main effect is not sphincter contraction but sensitization of the patient to the anal area, or simply the effect of intervening per se. Home electric stimulation is a relatively cheap and generally well-tolerated therapy in the conservative treatment of fecal incontinence.

Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer.

INTRODUCTION: Following recto-sigmoid resection some patients may become faecally incontinent and remain so despite conservative treatment. This multicentre prospective study assessed the use of sacral nerve stimulation (SNS) in this group. METHODS: All patients had more than or equal to 4 days of faecal incontinence for solid or liquid stools over a 21-day period following recto-sigmoid resection for colorectal carcinoma. The operation had to have been deemed curative. They had to have failed pharmacological and biofeedback treatment. RESULTS: Three male patients met these criteria. One had had a colo-anal and two a colo-rectal anastomosis for rectal carcinoma. All patients had intact internal and external anal sphincters. Two patients had a successful temporary stimulation period and proceeded to permanent implantation. Pre-operative symptom duration was 1 year in the permanently implanted patients. They were followed up for 12 months. SNS improved the number of faecally incontinent episodes in both patients. Ability to defer was improved in both patients from 0--5 min to 5--15 min. The faecal incontinence-specific ASCRS quality of life assessment improved in all four subcategories. CONCLUSION: This study demonstrates that SNS may be effective in the treatment of patients with faecal incontinence following recto-sigmoid resection if conservative treatment has failed.

Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study.

PURPOSE: A proportion of patients have fecal incontinence secondary to a full-thickness rectal prolapse that fails to resolve following prolapse repair. This multicenter, prospective study assessed the use of sacral nerve stimulation for this indication. METHODS: Patients had to have more than or equal to four days with fecal incontinence per 21-day period more than one year after surgery. They had to have failed conservative treatment and have an intact external anal sphincter. RESULTS: Four female patients aged 42, 54, 68, and 65 years met the inclusion criteria. Three of the four patients had had more than one operation for recurrent full-thickness rectal prolapse before sacral nerve stimulation, one of whom had undergone a further operation for recurrence following stimulation. One patient had undergone one operation for prolapse repair. The preoperative duration of symptoms was ten, eight, three, and nine years, respectively. Although patients had an intact external anal sphincter, one patient had a fragmented internal anal sphincter. The frequency of fecal incontinent episodes changed from 11, 24.7, 5, and 8 per week at baseline to 0, 1.5, 5.5, and 1 per week at latest follow-up. Ability to defer defecation was also improved in two of three patients who had this documented. Fecal incontinence-specific quality of life assessment showed an improvement in all four domains. CONCLUSION: Sacral nerve stimulation should be considered for patients with ongoing fecal incontinence following full-thickness rectal prolapse repair if they prove resistant to conservative treatment.

Randomized controlled trial of biofeedback for fecal incontinence.

BACKGROUND & AIMS: Behavioral treatment (biofeedback) has been reported to improve fecal incontinence but has not been compared with standard care. METHODS: A total of 171 patients with fecal incontinence were randomized to 1 of 4 groups: (1) standard care (advice); (2) advice plus instruction on sphincter exercises; (3) hospital-based computer-assisted sphincter pressure biofeedback; and (4) hospital biofeedback plus the use of a home electromyelogram biofeedback device. Outcome measures included diary, symptom questionnaire, continence score, patient's rating of change, quality of life (short-form 36 and disease specific), psychologic status (Hospital Anxiety and Depression scale), and anal manometry. RESULTS: Biofeedback yielded no greater benefit than standard care with advice (53% improved in group 3 vs. 54% in group 1). There was no difference between the groups on any of the following measures: episodes of incontinence decreased from a median of 2 to 0 per week (P < 0.001). Continence score (worst = 20) decreased from a median of 11 to 8 (P < 0.001). Disease-specific quality of life, short-form 36 (vitality, social functioning, and mental health), and Hospital Anxiety and Depression scale all significantly improved. Patients improved resting, squeeze, and sustained squeeze pressures (all P < 0.002). These improvements were largely maintained 1 year after finishing treatment. CONCLUSIONS: Conservative therapy for fecal incontinence improves continence, quality of life, psychologic well-being, and anal sphincter function. Benefit is maintained in the medium term. Neither pelvic floor exercises nor biofeedback was superior to standard care supplemented by advice and education.