Constipation Clinical Trial
Official title:
Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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