Constipation Clinical Trial
Official title:
Home Versus Office Biofeedback Training for Dyssynergic Defecation
Verified date | June 2017 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Test the Efficacy of Home Biofeedback Training: Currently, biofeedback requires a skilled
therapist and sophisticated equipment and is not widely available. The investigators designed
and tested a novel home biofeedback device and predict that home training will be as
effective as office biofeedback therapy. Our specific aims are to perform a randomized
controlled trial of 100 subjects with dyssynergic defecation to investigate:
(A) Whether a self-administered, home-biofeedback training program with a new portable device
is as effective as office-based biofeedback therapy in improving i) physiology- dyssynergia
(defecation index), and ability to expel simulated stool, and ii) symptomatology-
satisfaction with bowel function, number of complete spontaneous bowel movements, stool
consistency, straining and quality of life.
(B) Whether home-training is more cost-effective than office-based biofeedback training.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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): - stool frequency of less than three/week, - passage of hard stools, - excessive straining, - a feeling of incomplete evacuation, - sensation of anorectal obstruction or blockage and - 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. Exclusion Criteria: - Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued) - Patients with co-morbid 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. - Ulcerative/Crohns colitis. - Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery. - Rectal prolapse or anal fissure. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Augusta University | National Institutes of Health (NIH) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of Dyssynergia | Dyssynergia pattern | 3 months | |
Primary | Balloon Expulsion Time | Time it takes for a subject to expel a balloon that has been inserted into the rectum. | 3 months | |
Primary | Number of Complete Spontaneous Bowel Movements | Number of how many bowel movements occur without using an aid to have a bowel movement. | 3 months | |
Primary | Global Bowel Satisfaction | visual analog scale of symptoms | 3 months | |
Secondary | Colon Transit | colon transit time | 3 months |
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