A Study of Abdominal Wall Muscle Contractions in Healthy and Disordered Defecation

Overview

About this study

The purpose of this study is to assess abdominal wall contractions at rest, during maneuvers which activate the abdominal wall, and during simulated rectal evacuation in healthy women and patients with disordered defecation.

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 - healthy women:

  • Healthy volunteers aged 18-80 years.
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Inclusion Criteria - female patients, aged 18-80 years:

  • Defecatory disorders.Women with (a) symptoms of 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 evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time; (b) diagnostic tests indicative of difficult defecation; (c) scheduled to undergo pelvic floor retraining by biofeedback therapy.
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria - healthy women:

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

  • 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.*
  • Current symptoms of a functional gastrointestinal disorder assessed by questionnaire 32, 33.
  • Putative risk factors for pelvic floor trauma, i.e. six or more vaginal deliveries, birthweight >4500gms (macrosomia), or known 4th degree perineal tear.
  • Medications that are likely to alter gastrointestinal motility, e.g., opiates, anticholinergic medications, alpha adrenergic agonists, calcium channel or b blockers; stable dose of thyroxine will be permitted.
  • Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.*
  • Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire 34.
  • BMI greater than 32 kg/m2.*

 

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.

Closed for enrollment

Contact information:

Kelly Feuerhak R.N., CCRP

(507) 255-6802

Feuerhak.Kelly@mayo.edu

More information

Publications

Publications are currently not available