Improving Anorectal Testing for Defecatory Disorders and Fecal Incontinence

Overview

About this study

The purpose of this study is to better understand the mechanisms by which people retain control of their bowel contents and evacuate stool (defecation) and why people have constipation or fecal incontinence (involuntary stool leakage). Pressure measurements (by manometry) and magnetic resonance imaging (MRI) are widely used for diagnosis in patients with constipation or fecal incontinence. This study is trying to improve the utility of these tests for diagnosing these problems and to understand if pressure measurements (by manometry) can be related to strength of the anal sphincter measured by MRI. To do this, we will study the effects of alfuzosin on these muscles.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Controls
    1. Healthy women volunteers aged 18-80 years
    2. Able to provide written informed consent before participating in the study
    3. Able to communicate adequately with the investigator and to comply with the requirements for the entire study
  2. Patients (women aged 18-80 years)
    1. Fecal incontinence. Women with fecal incontinence occurring more than once per month
    2. Constipation.  Women with chronic constipation for 1 year with any 2 or more of the following symptoms for 3 months or longer, i.e. <3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, incomplete{C}{C}{C}
    3. Able to provide written informed consent before participating in the study
    4. Able to communicate adequately with the investigator and to comply with the requirements for the entire study

Exclusion Criteria:

Items indicated with an asterisk (*) are also exclusion criteria for patients

  1. Controls
    1. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*
    2. Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
    3. Putative risk factors for pelvic floor trauma, i.e. six or more vaginal deliveries, birthweight >4500gms (macrosomia), or known 4th degree perineal tear
    4. Medications that are likely to alter gastrointestinal motility, e.g., opiates, anticholinergic medications, high doses of serotoninergic agents (e.g. fluoxetine 80mg or greater), alpha adrenergic agonists, calcium channel or b blockers; stable dose of thyroxine will be permitted
    5. Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease*
    6. Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire
    7. Contraindications for MR imaging, i.e. pacemakers, aneurysm clips, cochlear implants
    8. Pregnant women, prisoners and institutionalized individuals

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adil Bharucha, M.B.B.S., M.D.

Open for enrollment

Contact information:

Kelly Feuerhak CCRP

(507) 255-6802

Feuerhak.Kelly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available