Rectal Sensory Training - A Study of Two Techniques

Constipation Clinical Trial

Official title: Rectal Sensory Training - A Randomized Controlled Study of Two Techniques

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Rectal Hyposensitivity

• NCT number: NCT00982839
• Study type: Interventional
• Source: Georgia Regents University
• Status: Completed
• Phase: Phase 2
• Start date: March 2004
• Completion date: July 2014