View Clinical Trial (Medical Research Study)
Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Rectal Hyposensitivity - Constipation |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00982839 |
| Primary Contact: |
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Principal Investigator
Satish Rao, Md, PhD
University of Iowa
Satish SC Rao, MD
Phone: 319-353-6602
Email: satish-rao@uiowa.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Iowa City, Iowa 52242
United States
Satish SC Rao, MD
Phone: 319-353-6602
Email: satish-rao@uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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