title: Effects of clonidine in women with fecal incontinence.
abstract: OBJECTIVE
  Some women with urge-predominant fecal incontinence (FI) have diarrhea-predominant irritable bowel syndrome and a stiffer and hypersensitive rectum. We evaluated the effects of the α2-adrenergic agonist clonidine on symptoms and anorectal functions in women with FI in a prospective, placebo-controlled trial.
  
  
  METHODS
  We assessed bowel symptoms and anorectal functions (anal pressures, rectal compliance, and sensation) in 43 women (age, 58 ± 2 y) with urge-predominant FI, randomly assigned to groups given oral clonidine (0.1 mg, twice daily) or placebo for 4 weeks. Before and after administration of the medication, anal pressures were evaluated by manometry, and rectal compliance and sensation were measured using a barostat. Anal sphincter injury was evaluated by endoanal magnetic resonance imaging. Bowel symptoms were recorded in daily and weekly diaries. The primary end point was the FI and Constipation Assessment symptom severity score.
  
  
  RESULTS
  FI scores decreased from 9.1 ± 0.3 to 7.6 ± 0.5 among subjects given placebo and from 8.1 ± 0.4 to 6.5 ± 0.6 among patients given clonidine. Clonidine did not affect FI symptom severity, bowel symptoms (stool consistency or frequency), anal pressures, rectal compliance, or sensation compared with placebo. However, when baseline data were used to categorize subjects as those with or without diarrhea, clonidine reduced the proportion of loose stools in patients with diarrhea only (P = .018). Clonidine also reduced the proportion of days with FI in patients with diarrhea (P = .0825).
  
  
  CONCLUSIONS
  Overall, clonidine did not affect bowel symptoms, fecal continence, or anorectal functions, compared with placebo, in women with urge-predominant FI. Among patients with diarrhea, clonidine increased stool consistency, with a borderline significant improvement in fecal continence. ClinicalTrials.gov, Number NCT00884832.
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: bharucha.adil@mayo.edu.
authors.forename: Adil E
authors.initials: AE
authors.lastname: Bharucha
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Joel G
authors.initials: JG
authors.lastname: Fletcher
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Michael
authors.initials: M
authors.lastname: Camilleri
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Jessica
authors.initials: J
authors.lastname: Edge
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Paula
authors.initials: P
authors.lastname: Carlson
authors.affiliation: Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Zinsmeister
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D058647:Adrenergic alpha-2 Receptor Agonists / Q000627:therapeutic use*; D000368:Aged; D001003:Anal Canal / Q000502:physiology; D003000:Clonidine / Q000627:therapeutic use*; D005242:Fecal Incontinence / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008365:Manometry; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D010919:Placebos; D003000:Clonidine
keywords: FICA; IBS; MRI; Randomized Controlled Trial; Stool Consistency
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