Plugs for containing faecal incontinence.

BACKGROUND: Faecal incontinence is a distressing disorder with high social stigma. Not all people with faecal incontinence can be cured with conservative or surgical treatment and they may need to rely on containment products, such as anal plugs. OBJECTIVES: To assess the performance of different types of anal plugs for containment of faecal incontinence. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, ClinicalTrials.gov, World Health Organization (WHO) ICTRP and handsearching of journals and conference proceedings (searched 26 May 2015). Reference lists of identified trials were searched and plug manufacturers were contacted for trials. No language or other limitations were imposed. SELECTION CRITERIA: Types of studies: this review was limited to randomised and quasi-randomised controlled trials (including crossovers) of anal plug use for the management of faecal incontinence. TYPES OF PARTICIPANTS: children and adults with faecal incontinence.Types of interventions: any type of anal plug. Comparison interventions might include no treatment, conservative (physical) treatments, nutritional interventions, surgery, pads and other types or sizes of plugs. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data from the included trials. Authors of all included trials were contacted for clarification concerning methodological issues. MAIN RESULTS: Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs, one study compared two sizes of the same brand of plug, and one study compared two brands of plugs. In all included studies there was considerable dropout (in total 48 (35%) dropped out before the end of the study) for varying reasons. Data presented are thus subject to potential bias. 'Pseudo-continence' was, however, achieved by some of those who continued to use plugs, at least in the short-term. In a comparison of two different types of plug, plug loss was less often reported and overall satisfaction was greater during use of polyurethane plugs than polyvinyl-alcohol plugs. AUTHORS' CONCLUSIONS: The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.

Plugs for containing faecal incontinence.

BACKGROUND: Faecal incontinence is a distressing disorder with high social stigma. Not all people with faecal incontinence can be cured with conservative or surgical treatment and they may need to rely on containment products, such as anal plugs. OBJECTIVES: To assess the performance of different types of anal plugs for containment of faecal incontinence. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register (searched 29 February 2012). Reference lists of identified trials were searched and plugs manufacturers were contacted for trials. No language or other limitations were imposed. SELECTION CRITERIA: Types of studies: This review was limited to randomised and quasi-randomised controlled trials (including crossovers) of anal plug use for the management of faecal incontinence. TYPES OF PARTICIPANTS: Children and adults with faecal incontinence.Types of interventions: Any type of anal plug. Comparison interventions might include no treatment, conservative (physical) treatments, nutritional interventions, surgery, pads and other types or sizes of plugs. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data from the included trials. Authors of all included trials were contacted for clarification concerning methodological issues. MAIN RESULTS: Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs, one study compared two sizes of the same brand of plug, and one study compared two brands of plugs. In all included studies there was considerable dropout (in total 48 (35%) dropped out before the end of the study) for varying reasons. Data presented are thus subject to potential bias. 'Pseudo-continence' was, however, achieved by some of those who continued to use plugs, at least in the short-term. In a comparison of two different types of plug, plug loss was less often reported and overall satisfaction was greater during use of polyurethane plugs than polyvinyl-alcohol plugs. AUTHORS' CONCLUSIONS: The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.

Cross-sectional imaging of the anal sphincter in fecal incontinence.

OBJECTIVE: Fecal incontinence is a disabling disorder. Cross-sectional imaging techniques can be used to confirm the diagnosis and to clarify the anatomy and function of the anorectal region. CONCLUSION: Cross-sectional imaging has increased the understanding of the sphincter complex, resulting in a more adequate evaluation of fecal incontinence.

The role of endoluminal imaging in clinical outcome of overlapping anterior anal sphincter repair in patients with fecal incontinence.

OBJECTIVE: Anterior sphincter repair has become the operation of choice in patients with fecal incontinence who have defects of the external anal sphincter (EAS), but not all patients benefit from surgery. The aim of this study was to investigate whether endoluminal imaging can identify determinants that play a role in the outcome of sphincter repair. SUBJECTS AND METHODS: Thirty fecal incontinent patients with an EAS defect were included. The severity of incontinence was evaluated pre- and postoperatively using the Vaizey incontinence score. Patients underwent endoanal MRI and endoanal sonography before and after sphincter repair. We evaluated the association between preoperatively assessed EAS measurements with outcome and postoperatively depicted residual defects, atrophy, tissue at overlap, and sphincter overlap with clinical outcome. RESULTS: After surgery, the mean Vaizey score in 30 patients (97% females; mean age, 50 years) had improved from 18 to 13 (p < 0.001). MRI showed that baseline measurement of preserved EAS thickness correlated with a better outcome (r = 0.42; p = 0.03). Clinical outcome did not differ between patients with and those without a persistent EAS defect (p = 0.54) or EAS atrophy (p = 0.26) depicted on MRI. Patients with a visible overlap and less than 20% fat tissue had a better outcome than patients with nonvisible, fatty overlap (decrease in Vaizey score, 7 vs 2 points, respectively; p = 0.04). Sonography showed that patients with a persistent EAS defect had a worse outcome than those without an EAS defect (17 vs 10 points, respectively; p = 0.003). CONCLUSION: Endoanal MRI was useful in determining EAS thickness and structure, and endoanal sonography was effective in depicting residual EAS defects.

MRI in evaluating atrophy of the external anal sphincter in patients with fecal incontinence.

OBJECTIVE: External anal sphincter atrophy seen at endoanal MRI may predict poor outcome of surgical anal sphincter repair for an external anal sphincter defect. The purposes of this study were to compare external phased-array MRI to endoanal MRI for depicting external anal sphincter atrophy in patients with fecal incontinence and to evaluate observer reproducibility in detecting external anal sphincter atrophy with these techniques. SUBJECTS AND METHODS: Thirty patients with fecal incontinence (23 women, seven men; mean age, 58.7 years; age range, 37-78 years) underwent both endoanal and external phased-array MRI. Images were evaluated for external anal sphincter atrophy by three radiologists. Measures of differences and agreement between both MRI techniques and of interobserver and intraobserver agreement of both techniques were calculated. RESULTS: The MRI techniques did not significantly differ in their ability to depict external anal sphincter atrophy (p = 0.63) with good agreement (kappa = 0.72). Interobserver agreement was moderate (kappa = 0.53-0.56) for endoanal MRI and moderate to good (kappa = 0.55-0.8) for external phased-array MRI. Intraobserver agreement was moderate to very good (kappa = 0.57-0.86) for endoanal MRI and fair to very good (kappa = 0.31-0.86) for external phased-array MRI. CONCLUSION: External phased-array MRI is comparable to endoanal MRI in depicting external anal sphincter atrophy and, thereby, in selecting patients for anal sphincter repair. Because results among interpreters varied considerably depending on the experience level, both techniques can be recommended in the diagnostic workup of fecal incontinence only if sufficient experience is available.

Evaluation of an MRI-based score of disease activity in perianal fistulizing Crohn's disease.

To evaluate a magnetic resonance imaging (MRI)-based score of disease severity for perianal fistulizing Crohn's disease (CD), 16 patients with perianal fistulizing CD underwent 1.5-T MRI before and after infliximab therapy. MRI scores, Perianal Disease Activity Index (PDAI) and C-reactive protein (CRP) were calculated, and fistula drainage was assessed. These items were compared for responders and nonresponders. After therapy, PDAI values and CRP values decreased significantly in responders, but there were no significant differences in the MRI scores. In all responders, MRI findings were indicative of persisting active inflammation. In these patients, a relapse rate of 57% was seen.

Magnetic resonance imaging of the small bowel with the true FISP sequence: intra- and interobserver agreement of enteroclysis and imaging without contrast material.

PURPOSE: This study aimed to determine the reliability of magnetic resonance imaging (MRI) without luminal contrast medium versus MR enteroclysis for evaluating small bowel pathology, to compare MRI and MRE findings per observer, and to compare these findings with those of an expert reader in order to determine the influence of luminal contrast medium on morphological evaluations. CONCLUSION: The use of luminal contrast medium bowel improves reliability for measuring bowel wall thickness and for the diagnosis and grading of obstruction when evaluating the small bowel.

Pelvic floor muscle lesions at endoanal MR imaging in female patients with faecal incontinence.

To evaluate the frequency and spectrum of lesions of different pelvic floor muscles at endoanal MRI in women with severe faecal incontinence and to study their relation with incontinence severity and manometric findings. In 105 women MRI examinations were evaluated for internal anal sphincter (IAS), external anal sphincter (EAS), puborectal muscle (PM) and levator ani (LA) lesions. The relative contribution of lesions to differences in incontinence severity and manometric findings was studied. IAS (n = 59) and EAS (n = 61) defects were more common than PM (n = 23) and LA (n = 26) defects. PM and LA defects presented mainly with IAS and/or EAS defects (isolated n = 2 and n = 3). EAS atrophy (n = 73) was more common than IAS (n = 19), PM (n = 16) and LA (n = 9) atrophy and presented mainly isolated. PM and LA atrophy presented primarily with EAS atrophy (isolated n = 3 and n = 1). Patients with IAS and EAS lesions had a lower resting and squeeze pressure, respectively; no other associations were found. PM and LA lesions are relatively common in patients with severe faecal incontinence, but the majority of lesions are found in women who also have IAS and/or EAS lesions. Only an association between anal sphincter lesions and manometry was observed.

Clinical presentation of fecal incontinence and anorectal function: what is the relationship?

OBJECTIVES: Fecal incontinence is classified into various types: passive, urge, and combined. Its clinical presentation is thought to be related to the underlying physiological or anatomical abnormality. The aim of the present study was to evaluate the associations between the frequency of clinical symptoms and anatomic and functional characteristics of the anorectum of patients with severe fecal incontinence. METHODS: Associations were explored in a consecutive series of 162 patients (91% women, mean age 59 [SD +/- 12] yr) with a mean Vaizey incontinence score of 18 (SD +/- 3). RESULTS: Urge incontinence was reported as "daily" by 55%, "often" by 27%, and "sometimes" by 7% of all patients. No significant associations were observed between the frequency of urge incontinence and either manometric data, anal mucosal sensitivity testing, or defects of internal anal sphincter (IAS) or external anal sphincter (EAS). A significant relation was observed between the frequency of urge incontinence and maximal tolerable volume (P= 0.03) and atrophy of the EAS (P= 0.05). Passive incontinence was reported as "daily" by 14%, "often" by 30%, and "sometimes" by 14% of all patients. Resting and maximal squeeze pressure were both associated (P < 0.001) with the frequency of passive incontinence. No relationship could be detected between clinical presentation and rectal sensation, anal mucosal sensitivity, defects, or atrophy of IAS or EAS. CONCLUSION: Most patients reported combined incontinence (59%) and underlying pathophysiologic abnormalities were identified. The hypothesized associations between urge and passive incontinence and functional and anatomical impairment of the anorectum are less clear-cut than previously assumed. Patients presenting with fecal incontinence should undergo physiologic investigation.

Anal inspection and digital rectal examination compared to anorectal physiology tests and endoanal ultrasonography in evaluating fecal incontinence.

BACKGROUND: Anal inspection and digital rectal examination are routinely performed in fecal incontinent patients but it is not clear to what extent they contribute to the diagnostic work-up. We examined if and how findings of anal inspection and rectal examination are associated with anorectal function tests and endoanal ultrasonography. METHODS: A cohort of fecal incontinent patients (n=312, 90% females; mean age 59) prospectively underwent anal inspection and rectal examination. Findings were compared with results of anorectal function tests and endoanal ultrasonography. RESULTS: Absent, decreased and normal resting and squeeze pressures at rectal examination correlated to some extent with mean (+/-SD) manometric findings: mean resting pressure 41.3 (+/-20), 43.8 (+/-20) and 61.6 (+/-23) Hg (p<0.001); incremental squeeze pressure 20.6 (+/-20), 38.4 (+/-31) and 62.4 (+/-34) Hg (p<0.001). External anal sphincter defects at rectal examination were confirmed with endoanal ultrasonography for defects <90 degrees in 36% (37/103); for defects between 90-150 degrees in 61% (20/33); for defects between 150-270 degrees in 100% (6/6). Patients with anal scar tissue at anal inspection had lower incremental squeeze pressures (p=0.04); patients with a gaping anus had lower resting pressures (p=0.013) at anorectal manometry. All other findings were not related to any anorectal function test or endoanal ultrasonography. CONCLUSIONS: Anal inspection and digital rectal examination can give accurate information about internal and external anal sphincter function but are inaccurate for determining external anal sphincter defects <90 degrees. Therefore, a sufficient diagnostic work-up should comprise at least rectal examination, anal inspection and endoanal ultrasonography.

External anal sphincter defects in patients with fecal incontinence: comparison of endoanal MR imaging and endoanal US.

PURPOSE: To prospectively compare in a multicenter study the agreement between endoanal magnetic resonance (MR) imaging and endoanal ultrasonography (US) in depicting external anal sphincter (EAS) defects in patients with fecal incontinence. MATERIALS AND METHODS: The study was approved by the medical ethics committee of all participating centers. A total of 237 consenting patients (214 women, 23 men; mean age, 58.6 years +/- 13 [standard deviation]) with fecal incontinence were examined from 13 different hospitals by using endoanal MR imaging and endoanal US. Patients with an anterior EAS defect depicted on endoanal MR images and/or endoanal US scans underwent anal sphincter repair. Surgical findings were used as the reference standard in the determination of anterior EAS defects. The Cohen kappa statistic and McNemar test were used to calculate agreement and differences between diagnostic techniques. RESULTS: Agreement between endoanal MR imaging and endoanal US was fair for the depiction of sphincter defects (kappa = 0.24 [95% confidence interval: 0.12, 0.36]). At surgery, EAS defects were found in 31 (86%) of 36 patients. There was no significant difference between MR imaging and US in the depiction of sphincter defects (P = .23). Sensitivity and positive predictive value were 81% and 89%, respectively, for endoanal MR imaging and 90% and 85%, respectively, for endoanal US. CONCLUSION: In the selection of patients for anal sphincter repair, both endoanal MR imaging and endoanal US are sensitive tools for preoperative assessment, and both techniques can be used to depict surgically repairable anterior EAS defects.

Functional changes after physiotherapy in fecal incontinence.

BACKGROUND: Physiotherapy is a common treatment option in patients with fecal incontinence. Although physiotherapy may result in relief of symptoms, to what extent improvement is associated with changes in anorectal function is still unclear. AIM: The aim of the present study was to investigate prospectively how anorectal function changes with physiotherapy and whether these changes are related to changes in fecal incontinence score. METHODS: Consenting consecutive patients (n=266) with fecal incontinence (91% women; mean age, 59 years) underwent anorectal manometry, anal and rectal mucosal sensitivity measurements, and rectal capacity measurement at baseline and after nine sessions of standardized pelvic floor physiotherapy. These findings were compared with changes in Vaizey incontinence score. RESULTS: On follow-up 3 months after physiotherapy, squeeze pressure (p=0.028), as well as urge sensation threshold (p=0.046) and maximum tolerable volume (p=0.018), had increased significantly. The extent of improvement was not related to age, duration of fecal incontinence, menopause, and endosonography findings. All other anorectal functions did not change. An improvement in the Vaizey score was moderately correlated with an increase in incremental squeeze pressure (r=0.14, p=0.04) and a decrease in anal mucosal sensitivity threshold (r=0.20, p=0.01). CONCLUSIONS: Physiotherapy improves squeeze pressure, urge sensation, and maximum tolerable volume. However, improved anorectal function does not always result in a decrease in fecal incontinence complaints.

Relationship between external anal sphincter atrophy at endoanal magnetic resonance imaging and clinical, functional, and anatomic characteristics in patients with fecal incontinence.

PURPOSE: External anal sphincter atrophy at endoanal magnetic resonance imaging has been associated with poor outcome of anal sphincter repair. We studied the relationship between external anal sphincter atrophy on endoanal magnetic resonance imaging and clinical, functional, and anatomic characteristics in patients with fecal incontinence. METHODS: In 200 patients (mean Vaizey score, 18 (+/-2.9 standard deviation)) magnetic resonance images were evaluated for external anal sphincter atrophy (none, mild, or severe) by radiologists blinded to anorectal functional test results and details from medical history. Subgroups of patients with and without atrophy were compared for medical history, anal manometry, pudendal nerve latency testing, anal sensitivity testing, external anal sphincter thickness, and external anal sphincter defects. Whenever significant differences were detected, we tested for differences between patients with mild and severe atrophy. RESULTS: External anal sphincter atrophy was demonstrated in 123 patients (62 percent): graded as mild in 79 (40 percent), and severe in 44 patients (22 percent). Patients with atrophy were more often female (P < 0.001) and older (P = 0.003). They had a lower maximal squeeze (P = 0.01) and squeeze increment pressure (P < 0.001). Patients with severe atrophy had a lower maximal squeeze (P = 0.003) and squeeze increment pressure (P < 0.001) than patients with mild atrophy. These effects were not attenuated by potential confounding variables. Patients with atrophy could not be identified a priori by other characteristics. CONCLUSIONS: External anal sphincter atrophy at endoanal magnetic resonance imaging was depicted in 62 percent of patients, varying from mild to severe. Because increasing levels of atrophy were associated with impaired squeeze function, further studies are needed to evaluate whether grading atrophy is clinically valuable in selecting patients for anal sphincter repair.

Costs of outpatients with fecal incontinence.

OBJECTIVE: Fecal incontinence is a problem with a high prevalence. Patients generally suffer from their problems for many years. It has been shown that quality of life is negatively affected but health economic data for fecal incontinence are limited. The aim of this study was to estimate the costs associated with fecal incontinence in a large outpatient study group, taking a societal perspective. MATERIAL AND METHODS: Based on questionnaire data, we calculated the costs of health-care resources, out-of-pocket expenses and costs associated with production losses in paid and unpaid work. RESULTS: Data were available for 253 patients, of which 228 (90%) were female and 209 (83%) were treated in an academic medical center. The mean age of patients was 59 years (SD+/-13) with a mean duration of incontinence of 8.5 years (SD+/-8.3). Total costs were estimated on C2169 per fecal incontinent patient per year. Production losses in paid and unpaid work accounted for more than half of the total costs and costs of health-care visits accounted for almost a fifth of total costs. Costs associated with protective material (partially reimbursable and not reimbursable) formed only one-tenth of total costs, while incontinence medication was responsible for only 5% of total costs. CONCLUSIONS: More than half of total costs of fecal incontinence are made up of indirect non-medical costs. The costs associated with the use of incontinence material and other personal expenses are limited.

Prospective assessment of interobserver agreement for defecography in fecal incontinence.

OBJECTIVE: The primary aim of our study was to determine the interobserver agreement of defecography in diagnosing enterocele, anterior rectocele, intussusception, and anismus in fecal-incontinent patients. The subsidiary aim was to evaluate the influence of level of experience on interpreting defecography. SUBJECTS AND METHODS: Defecography was performed in 105 consecutive fecal-incontinent patients. Observers were classified by level of experience and their findings were compared with the findings of an expert radiologist. The quality of the expert radiologist's findings was evaluated by an intraobserver agreement procedure. RESULTS: Intraobserver agreement was good to very good except for anismus: incomplete evacuation after 30 sec (kappa, 0.55) and puborectalis impression (kappa, 0.54). Interobserver agreement for enterocele and rectocele was good (kappa, 0.66 for both) and for intussusception, fair (kappa, 0.29). Interobserver agreement for anismus: incomplete evacuation after 30 sec was moderate (kappa, 0.47), and for anismus: puborectalis impression was fair (kappa, 0.24). Agreement in grading of enterocele and rectocele was good (kappa, 0.64 and 0.72, respectively) and for intussusception, fair (kappa, 0.39). Agreement separated by experience level was very good for rectocele (kappa, 0.83) and grading of rectoceles (kappa, 0.83) and moderate for intussusception (kappa, 0.44) at the most experienced level. For enterocele and grading, experience level did not influence the reproducibility. CONCLUSION: Reproducibility for enterocele, anterior rectocele, and severity grading is good, but for intussusception is fair to moderate. For anismus, the diagnosis of incomplete evacuation after 30 sec is more reproducible than puborectalis impression. The level of experience seems to play a role in diagnosing anterior rectocele and its grading and in diagnosing intussusception.

Selecting an outcome measure for evaluating treatment in fecal incontinence.

PURPOSE: Various outcome measures exist to evaluate treatment in fecal incontinence, including descriptive, severity (fecal incontinence scoring systems), and impact (quality-of-life questionnaires) and diagnostic measures. We studied associations between changes after treatment for a number of outcome measures and compared them to patients' subjective perception of relief. METHODS: We analyzed data of 66 patients (92 percent female; mean age, 62 years) (Vaizey score, Wexner score, two impact scales, utility, resting pressure, and maximal incremental squeeze pressure) at baseline and after physiotherapy. In a standardized interview by phone, we asked patients to compare their situation before and after treatment. Correlations between changes in outcome measures were calculated. These changes were compared with patients' subjective perception. RESULTS: There was a high correlation between the changes in the Vaizey and the Wexner scores (r = 0.94, P < 0.01). Changes in Vaizey and Wexner scores correlated moderately with changes in maximum incremental squeeze pressure (r = -0.29, -0.30, both P < 0.05). Changes in utility and resting pressure were not correlated with changes in any of the other measurements (all r values between -0.086 and 0.18). Average severity scores (Vaizey and Wexner) were 1 point lower for patients who rated their situation as worse or equal (62 percent), 4 points lower for patients who reported their situation to be better (21 percent), and 9 points lower in patients who rated their situation much better (17 percent) (P < .05). CONCLUSION: Severity measures are best related to patients' subjective perception of relief.

Anal sphincter defects in patients with fecal incontinence: endoanal versus external phased-array MR imaging.

PURPOSE: To prospectively compare external phased-array magnetic resonance (MR) imaging with endoanal MR imaging in depicting external and internal anal sphincter defects in patients with fecal incontinence and to prospectively evaluate observer reproducibility in the detection of external and internal anal sphincter defects with both MR imaging techniques. MATERIALS AND METHODS: The medical ethics committees of both participating hospitals approved the study, and informed consent was obtained. Thirty patients (23 women, seven men; mean age, 58.7 years; range, 37-78 years) with fecal incontinence underwent MR imaging with both endoanal and external phased-array coils. MR images were evaluated by three radiologists with different levels of experience for external and internal anal sphincter defects. Measures of inter- and intraobserver agreement of both MR imaging techniques and of differences between both imaging techniques were calculated. RESULTS: Both MR imaging techniques did not significantly differ in the depiction of external (P > .99) and internal (P > .99) anal sphincter defects. The techniques corresponded in 25 (83%) of 30 patients for the depiction of external anal sphincter defects and in 28 (93%) of 30 patients for the depiction of internal anal sphincter defects. Interobserver agreement was moderate to good for endoanal MR imaging and poor to fair for external phased-array MR imaging. Intraobserver agreement ranged from fair to very good for both imaging techniques. CONCLUSION: External phased-array MR imaging is comparable to endoanal MR imaging in the depiction of clinically relevant anal sphincter defects. Because of the weak interobserver agreement, both MR imaging techniques can be recommended in the diagnostic work-up of fecal incontinence only if sufficient experience is available.