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Biomedical subjects

Adil E Bharucha

Publications and source records attributed to Adil E Bharucha.

At least 19 recordsLinked to original sources
PubMed2026

Clinical Trial: Effectiveness and Safety of a Novel Anal Insert Device for Treatment of Faecal Incontinence.

BACKGROUND: Treatment options for medically-refractory faecal incontinence (FI)-including anorectal biofeedback, dextranomer injection, and sacral nerve stimulation-are limited and outcomes are often suboptimal. Anal or vaginal insert devices are infrequently used. AIMS: We evaluated the safety and effectiveness of a new anal insert device (StaySure) in patients with FI. METHODS: Patients with FI for&#x2009;&#x2265;&#x2009;6&#x2009;months and&#x2009;&#x2265;&#x2009;4 moderate or large FI episodes during a 4-week baseline entered a 2-4&#x2009;week fitting/run-in period to individualise device size (10 or 13&#x2009;mm) followed by a 4-week treatment period. Outcomes included effectiveness, safety, and quality of life (QoL). The primary outcome was the proportion achieving a&#x2009;&#x2265;&#x2009;50% reduction in FI frequency. RESULTS: Of 124 enrolled patients, 98, 71, and 61 progressed through the baseline, fitting/run-in, and treatment phases respectively, with few exclusions due to device intolerance. In the intent-to-treat cohort of 59 participants (93% women), mean (SD) number of days with FI declined from 13.2 (7.0) to 6.3 (6.9), and FI weekly episodes declined from 5.4 (6.9) to 2.1 (5.1) (69% reduction; p&#x2009;<&#x2009;0.001) with similar results for both device sizes. The primary endpoint was achieved in 76.3% of participants; 54.2% achieved&#x2009;&#x2265;&#x2009;75% reduction. The FIQoL overall score increased from a mean (SD) of 1.9 (0.6) to 2.3 (0.6) (p&#x2009;<&#x2009;0.001), indicating improved QoL. Improvements in FI frequency, FIQoL exceeded minimal clinically important difference thresholds, confirming clear clinical benefit. No treatment-related serious adverse events were reported. CONCLUSIONS: The StaySure anal insert device is safe, well tolerated, and effective in reducing FI in patients with moderate to severe symptoms refractory to conservative therapies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03898778.

Adult↗
PubMed2006

Rectal sensorimotor dysfunction in women with fecal incontinence.

The rate and pattern of rectal distension affect rectal distensibility, perception, and anal relaxation in health. Because rectal urgency is a prominent symptom in fecal incontinence (FI), we assessed rectal distensibility, contractions, perception, and anal pressures during rectal distention in 21 healthy, asymptomatic women (age 61 +/- 2 yr, mean +/- SE) and 51 women with FI (60 +/- 2 yr). Rectal staircases (0-32 mmHg, 4-mm steps) and ramp distensions [0-200 ml at 25, 50, and 100 ml/min with a phase of sustained distension (SD), lasting 1 min, between inflation and deflation]. The rectum was stiffer during rapid than slow ramp distention. This effect was more prominent at a lower volume (50 ml) and was also more pronounced in older subjects and in FI. A rectal contractile response was observed not only during inflation but also during SD and during deflation. During inflation, this contractile response was rate dependent in controls but not in FI. During staircase but not ramp distentions, the threshold for the desire to defecate was lower in FI. During ramp distentions, the duration of perception was significantly longer in FI. The rate of distention did not affect rectal perception (i.e., sensory thresholds or duration of perception) during ramp distentions. Baseline anal pressures and the magnitude of anal relaxation during rectal distention were also reduced in FI. In addition to reduced rectal capacity and compliance, women with FI had an exaggerated rate-dependent reduction in rectal distensibility, lower sensory thresholds, and more prolonged perception, indicative of rectoanal dysfunctions.

Enema↗
PubMed2006

Differences between painless and painful constipation among community women.

BACKGROUND: In the Rome II criteria, patients with both constipation and abdominal pain (AP) (i.e., "painful constipation" (PC)), who do not satisfy criteria for irritable bowel syndrome (IBS) are included in the same functional constipation (FC) category as patients with constipation without AP (i.e., "painless constipation" (PLC)). What differences, if any, exist between FC without (i.e., PLC) and with AP (i.e., PC) are unclear. METHODS: To compare clinical features among PLC, PC, constipation-predominant IBS (C-IBS), and non-C-IBS, a validated questionnaire was mailed (with telephone follow-up of nonresponders) to an age-stratified random sample of 5,200 adult women in Olmsted County, Minnesota. RESULTS: Altogether, 2,800 women (53%) responded. The age-adjusted prevalence of PLC (7.1 per 100; 95% confidence interval (95% CI), 6.2-8.0) was higher compared to PC (0.9 per 100; 95% CI, 0.6-1.2). Compared to PLC, patients with PC reported worse general health (i.e., excellent or very good = 37.5% vs 51.2%), more somatic symptoms (mean score = 1.3 vs 0.9), and urinary urgency (% often = 58% vs 32%), and had a higher prevalence of hysterectomy. Bowel symptoms significantly impacted > or =1 domain of quality of life (QOL) in 18% of PC versus 9% of PLC. In a logistic discriminant model, age, general health, impact of bowel symptoms on QOL, somatic symptoms, and urinary urgency independently discriminated between bowel subtypes. CONCLUSIONS: Patients with PC more closely resemble those with C-IBS than PLC. Consideration should be given to separating PC from PLC in the Rome criteria and in therapeutic trials.

Abdominal Pain↗
PubMed2006

Comparison of rectoanal axial forces in health and functional defecatory disorders.

Anal manometry measures circumferential pressures but not axial forces that are responsible for defecation and contribute to fecal continence. Our aims were to investigate these mechanisms by measuring axial rectoanal forces with an intrarectal sphere or a latex balloon fixed at 8, 6, or 4 cm from the anal verge and connected to axial force and displacement transducers. Rectoanal forces and rectal pressures within a latex balloon were measured at baseline (i.e., at rest) and during maneuvers (i.e., squeeze, simulated evacuation, and a Valsalva maneuver) in 12 asymptomatic women and 12 women with symptoms of difficult defecation. Anal resting and squeeze pressures were also assessed by manometry and were similar in control patients and experimental patients. At rest, axial rectoanal forces were directed inward and increased as the device approached the anal verge. Control patients augmented this inward force when they squeezed and exerted an outward force during simulated expulsion and a Valsalva maneuver. The force change during maneuvers was also affected by device location and was highest at 4 cm from the verge. In experimental patients, the force at rest and the change in force during all maneuvers was lower than in control patients. The rectal pressure during a Valsalva maneuver was also lower in experimental patients than in control patients, suggestive of impaired propulsion. In conclusion, a subset of women with defecatory symptoms had weaker axial forces not only during expulsion but also during a Valsalva maneuver and when they squeezed (i.e., contracted) their pelvic floor muscles, suggestive of generalized pelvic floor weakness.

Adult↗
PubMed2006

Effect of aging on anorectal and pelvic floor functions in females.

PURPOSE: In females, fecal incontinence often is attributed to birth trauma; however, symptoms sometimes begin decades after delivery, suggesting that anorectal sensorimotor functions decline with aging. METHODS: In 61 asymptomatic females (age, 44 +/- 2 years, mean +/- standard error of the mean) without risk factors for anorectal trauma, anal pressures, rectal compliance, and sensation were assessed by manometry, staircase balloon distention, and a visual analog scale during phasic distentions respectively. Anal sphincter appearance and pelvic floor motion also were assessed by static and dynamic magnetic resonance imaging respectively in 38 of 61 females. RESULTS: Aging was associated with lower anal resting (r = -0.44, P < 0.001) and squeeze pressures (r = -0.32, P = 0.01), reduced rectal compliance (i.e., r for pressure at half-maximum volume vs. age = 0.4, P = 0.001), and lower (P <or = 0.002) visual analog scale scores during phasic distentions at 16 (r = -0.5) and 24 mmHg (r = -0.4). Magnetic resonance imaging revealed normal anal sphincters in 29 females and significant sphincter injury, not associated with aging, in 9 females. The location of the anorectal junction at rest (r = 0.52, P < 0.001), squeeze (r = 0.62, P < 0.001), and Valsalva maneuver (r = 0.35, P = 0.03), but not anorectal motion (e.g., from resting to squeeze) was associated with age. CONCLUSIONS: In asymptomatic females, aging is associated with reduced anal resting and squeeze pressures, reduced rectal compliance, reduced rectal sensation, and perineal laxity. Together, these changes may predispose to fecal incontinence in elderly females.

Adult↗
PubMed2006

Symptoms and quality of life in community women with fecal incontinence.

BACKGROUND & AIMS: Assessments of symptom severity are necessary to guide therapy in fecal incontinence (FI). However, there is no consensus on how self-reported symptom severity in FI should be measured for this purpose, and the relationship between symptoms of FI and its impact on quality of life (QOL) is not known. METHODS: A questionnaire was mailed to an age-stratified random sample of 5300 women identified through the Rochester Epidemiology Project. Symptom severity was assessed by a validated scale (Fecal Incontinence and Constipation Assessment [FICA]), and impact on 15 domains of QOL was evaluated for subjects who had any FI during the past year. The scale incorporated the type, frequency, and amount of FI, as well as the circumstances surrounding FI (ie, urge or passive FI). A QOL-weighted symptom severity score was derived by weighting the responses for these characteristics, in each subject, by the average QOL impact for all subjects who reported that specific symptom characteristic. The relationship between symptom severity and the QOL-weighted symptom severity score was assessed by Spearman rank correlation. RESULTS: Altogether, 2800 of 5300 (53%) women responded to the survey. FI symptoms were mild (45%), moderate (50%), or severe (5%). Among women with FI, the FICA symptom severity scale was strongly correlated (r(s) = 0.92, P < .0001) with the QOL-weighted symptom severity score. CONCLUSIONS: Among unselected women in the community, self-reported symptom severity, rated by the FICA scale, was strongly correlated with the impact of FI on QOL, supporting the use of this scale to assess symptom severity in FI.

Activities of Daily Living↗
PubMed2006

Functional anorectal disorders.

This report defines criteria for diagnosing functional anorectal disorders (ie, fecal incontinence, anorectal pain, and disorders of defecation). Functional fecal incontinence is defined as the uncontrolled passage of fecal material recurring for > or =3 months in an individual with a developmental age of > or =4 years that is associated with: (1) abnormal functioning of normally innervated and structurally intact muscles, and/or (2) no or minor abnormalities of sphincter structure and/or innervation insufficient to explain fecal incontinence, and/or (3) normal or disordered bowel habits (ie, fecal retention or diarrhea), and/or (4) psychological causes. However, conditions wherein structural and/or neurogenic abnormalities explain the symptom, or are part of a generalized process (eg, diabetic neuropathy) are not included within functional fecal incontinence. Functional fecal incontinence is a common, but underrecognized symptom, which is equally prevalent in men and women, and can often cause considerable distress. The clinical features are useful for guiding diagnostic testing and therapy. Functional anorectal pain syndromes include proctalgia fugax (fleeting pain) and chronic proctalgia; chronic proctalgia may be subdivided into levator ani syndrome and unspecified anorectal pain, which are defined by arbitrary clinical criteria. Functional defecation disorders are characterized by 2 or more symptoms of constipation, with > or =2 of the following features during defecation: impaired evacuation, inappropriate contraction of the pelvic floor muscles, and inadequate propulsive forces. Functional disorders of defecation may be amenable to pelvic floor retraining by biofeedback therapy (such as dyssynergic defecation).

Anus Diseases↗
PubMed2006

Update of tests of colon and rectal structure and function.

This review deals with the indications, methods, strengths, and limitations of anorectal testing in clinical practice. In chronic constipation, anal manometry and a rectal balloon expulsion test, occasionally supplemented by defecography, are useful to identify a functional defecatory disorder, because symptoms may respond to pelvic floor retraining. In patients with fecal incontinence, diagnostic testing complements the clinical assessment for evaluating the pathophysiology and guiding management. Manometry measures anal resting and squeeze pressures, which predominantly reflect internal and external anal sphincter function, respectively. Defecation may be indirectly assessed by measuring the recto-anal pressure gradient during straining and by the rectal balloon expulsion test. Endoanal ultrasound and magnetic resonance imaging (MRI) can identify anal sphincter structural pathology, which may be clinically occult, and/or amenable to surgical repair. Only MRI can identify external sphincter atrophy, whereas ultrasound is more sensitive for internal sphincter imaging. By characterizing rectal evacuation and puborectalis contraction, barium defecography may demonstrate an evacuation disorder, excessive perineal descent or a rectocele. Dynamic MRI can provide similar information and also image the bladder and genital organs without radiation exposure. Because the measurement of pudendal nerve latencies suffers from several limitations, anal sphincter electromyography is recommended when neurogenic sphincter weakness is suspected.

Anal Canal↗
PubMed2006

Risk factors for fecal incontinence: a population-based study in women.

BACKGROUND: In women with "idiopathic" fecal incontinence (FI), consensus guidelines recommend anal sphincter imaging and surgical repair, when feasible, of anal sphincter defects believed to cause FI. However, the relative contributions of obstetric trauma and bowel symptoms to FI in the community are unknown. METHODS: To assess risk factors for FI during the past year, a previously validated questionnaire was mailed to an age-stratified random sample of 5,300 women residing in Olmsted County, Minnesota. RESULTS: Altogether, 2,800 women (53%) responded. The risk of fecal incontinence increased with age (odds ratio [OR] per decade 1.3, 95% CI 1.2-1.4). The risk of fecal incontinence was higher among women with rectal urgency (OR 8.3, 95% CI 4.8-14.3) whether or not they also had other bowel disturbances (i.e., constipation, diarrhea, or abdominal pain) or had a vaginal delivery with forceps or stitches (OR 9.0, 95% CI 5.6-14.4). Among women with FI, rectal urgency and age were also risk factors for symptom severity. In contrast, obstetric risk factors for anorectal trauma did not increase the risk for FI. The risk for FI was not significantly different among women with cesarean section, vaginal delivery with or without forceps or stitches, or anorectal surgery, compared with nulliparous women without any of these risk factors. CONCLUSIONS: Rectal urgency rather than obstetric injury is the main risk factor for FI in women. These observations reinforce the importance of behavioral, dietary, and pharmacological measures to ameliorate bowel disturbances before anal imaging in women with "idiopathic" FI.

Adult↗
PubMed2006

Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers.

Chloride channels modulate gastrointestinal neuromuscular functions in vitro. Lubiprostone, a selective type 2 chloride channel (ClC-2) activator, induces intestinal secretion and has been shown to relieve constipation in clinical trials; however, the effects of lubiprostone on gastric function and whole gut transit in humans are unclear. Our aim was to compare the effects of the selective ClC-2 activator lubiprostone on maximum tolerated volume (MTV) of a meal, postprandial symptoms, gastric volumes, and gastrointestinal and colonic transit in humans. We performed a randomized, parallel-group, double-blind, placebo-controlled study evaluating the effects of lubiprostone (24 microg bid) in 30 healthy volunteers. Validated methods were used: scintigraphic gastrointestinal and colonic transit, SPECT to measure gastric volumes, and the nutrient drink ("satiation") test to measure MTV and postprandial symptoms. Lubiprostone accelerated small bowel and colonic transit, increased fasting gastric volume, and retarded gastric emptying. MTV values were reduced compared with placebo; however, the MTV was within the normal range for healthy adults in 13 of 14 participants, and there was no significant change compared with baseline measurements. Lubiprostone had no significant effect on postprandial gastric volume or aggregate symptoms but did decrease fullness 30 min after the fully satiating meal. Thus the ClC-2 activator lubiprostone accelerates small intestinal and colonic transit, which confers potential in the treatment of constipation.

Adolescent↗
PubMed2005

The etiology, assessment, and treatment of fecal incontinence.

Fecal incontinence is a common symptom that often impairs quality of life. It is generally caused by a variety of conditions that are associated with anorectal sensorimotor dysfunction and/or diarrhea. Assessment should be tailored to age and symptom severity. Modulation of disordered bowel habits is the key to management; biofeedback and surgery might also be beneficial.

Antidiarrheals↗
PubMed2005

Phenotypic variation in functional disorders of defecation.

BACKGROUND & AIMS: Although obstructed defecation is generally attributed to pelvic floor dyssynergia, clinical observations suggest a wider spectrum of anorectal disturbances. Our aim was to characterize phenotypic variability in constipated patients by anorectal assessments. METHODS: Anal pressures, rectal balloon expulsion, rectal sensation, and pelvic floor structure (by endoanal magnetic resonance imaging) and motion (by dynamic magnetic resonance imaging) were assessed in 52 constipated women and 41 age-matched asymptomatic women. Phenotypes were characterized in patients by principal components analysis of these measurements. RESULTS: Among patients, 16 had a hypertensive anal sphincter, 41 had an abnormal rectal balloon expulsion test, and 20 had abnormal rectal sensation. Forty-nine patients (94%) had abnormal pelvic floor motion during evacuation and/or squeeze. After correcting for age and body mass index, 3 principal components explained 71% of variance between patients. These factors were weighted most strongly by perineal descent during evacuation (factor 1), anorectal location at rest (factor 2), and anal resting pressure (factor 3). Factors 1 and 3 discriminated between controls and patients. Compared with patients with normal (n = 23) or reduced (n = 18) perineal descent, patients with increased (n = 11) descent were more likely (P < or = .01) to be obese, have an anal resting pressure >90 mm Hg, and have a normal rectal balloon expulsion test result. CONCLUSIONS: These observations demonstrate that functional defecation disorders comprise a heterogeneous entity that can be subcharacterized by perineal descent during defecation, perineal location at rest, and anal resting pressure. Further studies are needed to ascertain if the phenotypes reflect differences in the natural history of these disorders.

Adult↗
PubMed2005

Prevalence and burden of fecal incontinence: a population-based study in women.

BACKGROUND & AIMS: The epidemiology of fecal incontinence (FI) is incompletely understood. We report the prevalence, clinical spectrum, health care-seeking behavior, and quality of life (QOL) in community women with FI. METHODS: A questionnaire was mailed to an age-stratified random sample of 5300 Olmsted County, Minnesota, women identified by the Rochester Epidemiology Project. Symptom severity was assessed by a validated scale, and impact on QOL was evaluated for subjects who had any FI during the past year. The prevalence of FI was calculated with direct age adjustment to the 2000 US white female population. RESULTS: Altogether, 2800 of 5300 women (53%) responded to the survey. The overall age-adjusted prevalence of FI in the past year was 12.1 per 100 (95% confidence interval, 11.0-13.1). The prevalence increased with age from 7 (third decade) to 22 (sixth decade) per 100 and was steady thereafter. Symptoms were mild (45%), moderate (50%), or severe (5%), and symptom severity was related to the impact of FI on QOL and physician-consulting behavior. Moderate to severe impact on >/=1 domain of QOL was reported by 6% with mild, 35% with moderate, and 82% with severe symptoms, whereas 5% with mild, 10% with moderate, and 48% with severe FI had consulted a physician for FI in the past year. CONCLUSIONS: More than 1 of 10 adult women in the population have FI; almost 1 of 15 have moderate to severe FI. FI significantly impacts QOL and prompts health care utilization predominantly in women with moderate to severe symptoms.

Adult↗
PubMed2005

Pelvic organ prolapse in defecatory disorders.

OBJECTIVE: To compare the prevalence of pelvic organ prolapse in subjects with defecatory disorders with that in control subjects. METHODS: In 55 subjects with fecal incontinence, 42 subjects with obstructed defecation, and 45 healthy subjects without defecatory symptoms, a urogynecologist assessed pelvic organ prolapse by the pelvic organ prolapse quantification system, and a gastroenterologist evaluated perineal descent during simulated evacuation. A multiple logistic regression model evaluated whether obstetric-gynecological variables, including pelvic organ prolapse, could discriminate among controls, subjects with fecal incontinence, and subjects with obstructed defecation. RESULTS: Fifty-five percent of controls, 42% of those with obstructed defecation, and 29% of those with fecal incontinence had stage II or greater prolapse by clinical examination. Eleven percent of controls, 7% of those with obstructed defecation, and 47% of subjects with fecal incontinence had a forceps delivery. Eighteen percent of controls, 31% of those with obstructed defecation, and 64% of those with fecal incontinence had a hysterectomy. Even after controlling for a higher prevalence of obstetric risk factors and hysterectomy, fecal incontinence was associated with a lower risk of stage II or greater pelvic organ prolapse (odds ratio for fecal incontinence in > or = stage II pelvic organ prolapse relative to stage 0 pelvic organ prolapse = 0.1, 95% confidence interval 0.01-0.53). In contrast, pelvic organ prolapse severity was not associated with control versus obstructed defecation status. Seven percent of controls, 18% of subjects with obstructed defecation, and 7% of those with fecal incontinence had increased perineal descent during simulated evacuation. Excessive perineal descent was associated (P < .01) with pelvic organ prolapse. CONCLUSION: Despite a higher prevalence of risk factors for pelvic floor injury, pelvic organ prolapse severity was lower in those with fecal incontinence than in subjects without bowel symptoms. However, a subset of subjects with defecatory disorders, predominantly obstructed defecation, have excessive perineal descent, which is associated with pelvic organ prolapse.

Adult↗
PubMed2004

Limitations of implantable, miniature ultrasonic transducers to measure wall movement in the canine jejunum.

BACKGROUND: We used implantable miniature ultrasonic transducers to measure longitudinal distance, circumference, and wall thickness dynamically in vivo in canine jejunum. We hoped to differentiate circular from longitudinal smooth muscle contractions and to correlate physical measurements of change in distance within the jejunal wall with intraluminal manometry. MATERIALS AND METHODS: In acute experiments at the time of celiotomy, longitudinal distances, circumferences, and wall thickness were measured directly and by ultrasonic transducers sewn to serosa and mucosa. Measurements were obtained with the intestine empty and after distention with air, water, or semisolid slurry. In chronic in vivo experiments in conscious dogs with indwelling ultrasonic transducers and intraluminal manometers, sonometric dimensions were correlated with manometric recordings. In acute experiments, sonometric measurements were similar to direct measurements. In chronic experiments in vivo, smallest ultrasonometric measurements of circumferences of the jejunum correlated in a phase-locked temporal manner with both highest intraluminal pressures and greatest wall thickness. RESULTS: Longitudinal distances increased during decreases in circumference. Distances orad to the site maximal intraluminal pressure peaked at 0.58 +/- 0.04 s ( x +/- SEM) before, and those aborad to this point 0.42 +/- 0.04 s after attaining minimum circumferences. CONCLUSIONS: Ultrasonic crystals can monitor geometric changes in the bowel wall with certain limitations, especially when obtained in vivo. Contraction of circular and longitudinal muscles, although phase-locked, do not appear to occur exactly synchronously in canine jejunum.

Animals↗