NCT00982839

Rectal Sensory Training - A Study of Two Techniques

Rectal Sensory Training - A Randomized Controlled Study of Two Techniques

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rectal Hyposensitivity
• Constipation

Interventions

Type	Name	Description
PROCEDURE	Syringe Conditioning	A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
PROCEDURE	Barostat Conditioning	A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.

Timeline

• Start date: 2004-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-09-23
• Last updated: 2014-09-17

Locations

1 site across 1 country: United States