Constipation Clinical Trial
Official title:
Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
Verified date | September 2014 |
Source | Georgia Regents University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
At least 60% of patients with constipation and dyssynergic defecation (anismus) and between
30-50% of patients with fecal incontinence exhibit impaired rectal sensation. The problem
may be improved by biofeedback therapy. Traditionally, biofeedback therapy was performed by
using a syringe-assisted technique. Although some respond to this method, many, particularly
those with severe rectal hyposensitivity have proved to be refractory. Also, repeated
inflation and deflation of a large volume of air, using a hand-held syringe is cumbersome
and time consuming. Recently, in pilot observations, the investigators have seen that a
barostat-assisted technique of biofeedback therapy was simpler and easier to perform and
could possibly be more effective. The investigators' aims are:
1. To perform a randomized controlled study that compares the syringe-assisted sensory
conditioning (biofeedback therapy) technique with the barostat assisted sensory
conditioning for improving the rectal sensation in patients with rectal hyposensitivity
and bowel dysfunction.
2. To investigate the impact of sensory conditioning on psychosocial issues and quality of
life.
3. To compare the cost-effectiveness of each therapeutic modality The specific hypotheses
that will be tested are;
When compared to those who receive syringe-assisted training, patients receiving barostat
training will demonstrate:
1. Lower sensory thresholds for rectal perception (first sensation, desire to defecate and
urgency)
2. Greater satisfaction with bowel function (VAS Score), stool frequency,consistency &
straining.
3. Better learning ability and greater ease of administering this training.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients categorized as having dyssynergic defecation or slow transit constipation or normal transit constipation will be eligible. - All patients must demonstrate rectal hyposensitivity during a manometry with values that are outside 2 S.D. of normal range and demonstrate any two of the following: a) Threshold for 1st sensation > 40 cc. b) Threshold for desire to defecate > 130 cc. c) Threshold for urgency to defecate >180 cc. 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 (22). - Ulcerative/Crohns colitis. - Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery. - Rectal prolapse or anal fissure. 11) Patients with severe rectal hyposensitivity, first sensation or desire to defecate > 320 cc |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Georgia Regents University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rectal Sensory Thresholds | Trial entry and at the end of 3 months | No | |
Secondary | Satisfaction with bowel function based on Visual Analog Scale (VAS) | Trial Entry and at the end of 3 months | No |
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