Status:
COMPLETED
Mechanism of Action of Biofeedback Therapy
Lead Sponsor:
Augusta University
Conditions:
Constipation
Hyposensitivity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Biofeedback therapy improves bowel symptoms and anorectal function in patients with dyssynergic defecation, however its mechanism of action is not known. The investigators hypothesize that biofeedback...
Eligibility Criteria
Inclusion
- During the previous year, all patients must have experienced or reported at least two of the following symptoms for at least three months and with 25% of bowel movements (when not taking laxatives) (22):1) stool frequency of less than three/week, 2) passage of hard stools, 3) excessive straining, 4) a feeling of incomplete evacuation, 5)sensation of anorectal obstruction or blockage and 6) use of manual maneuvers to facilitate defecations (e.g., digital evacuation).
- No evidence of structural disease (excluded by colonoscopy/ b. enema and metabolic problem by lab tests.
- Patients on stable doses of antidepressants without anticholinergic effects will be included.
- Patient must be undergoing biofeedback treatment
- Patient must be right-handed
Exclusion
- Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued)
- Patients with comorbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
- Neurologic diseases e.g.; head injury.epilepsy,multiple sclerosis, strokes, spinal cord injuries.
- Impaired cognizance (mini mental score of \< 15) and/or legally blind.
- Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
- Hirschsprung's disease.
- Alternating constipation and diarrhea (78).
- Ulcerative and Crohns colitis.
- Previous pelvic surgery, rectocele repair, bladder repair, radical hysterectomy.
- Rectal prolapse or anal fissure or anal surgery.
- Presence of metal in the skull, cranial cavity, back or hips.
- People who have a cardiac pacemaker, an implanted defibrillator, or a medication pump.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00988286
Start Date
August 1 2005
End Date
January 1 2016
Last Update
July 13 2017
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242