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Rectal Sensory Training - A Randomized Controlled Study of Two Techniques
Sponsor study identifier
interventional
70
1 country
1
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 22, 2009
Actual (reported)September 23, 2009
Actual (reported)July 2014
Actual (reported)July 2014
Actual (reported)Rectal Sensory Thresholds
Trial entry and at the end of 3 months
Satisfaction with bowel function based on Visual Analog Scale (VAS)
Trial Entry and at the end of 3 months
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Satish Rao, Md, PhD
University of Iowa
First Submitted
September 22, 2009
First Posted
September 23, 2009
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
July 2014
Actual (reported)Last Updated
September 17, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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