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Sierra High Definition Ano-Rectal Manometry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by University of Iowa.
Recruitment status was:  Recruiting
Information provided by:
University of Iowa Identifier:
First received: January 19, 2011
Last updated: March 7, 2011
Last verified: March 2011

Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately characterizes anorectal anatomy and function in healthy humans; HDM provides comparable information regarding the structure and function of the anorectal region, to that obtained from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence or constipation.

Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation will be recruited. Because anorectal disorders are more common in women, the investigators will recruit approximately 8 men and 12 women in each group. Each subject will undergo anorectal manometry, anal ultrasound and high definition manometry.

Data Analysis: Spearman correlational analysis will be performed to compare the parameters listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying anatomic sphincter defects will be assessed.

Fecal Incontinence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation [ Time Frame: One visit ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
healthy volunteers
patients with fecal incontinence
patients with constipation


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will recruit 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation. Because anorectal disorders are more common in women, we will recruit approximately 8 men and 12 women in each group. Because it is possible subjects may sign consent but not participate in the study, or drop out of the study before completion, we will recruit a total of 80 subjects.

Inclusion Criteria:

For patients:

  1. Either fecal incontinence (the occurrence of at least one episode of involuntary discharge of stool matter per week) or constipation (Rome III criteria) (16,17)
  2. Adults between the ages of 18-80 yrs.

For healthy volunteers:

  1. Adults between the ages of 18-80 yrs
  2. No gastrointestinal symptoms

Exclusion Criteria:

  1. Rectal prolapse or anal fissure on physical examination
  2. Recent pelvic or recto-anal surgery (< 6 months ago)
  3. History of pelvic irradiation.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01300884

United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Satish SC Rao, MD, PhD    319-353-6602   
Sponsors and Collaborators
University of Iowa
Principal Investigator: Satish SC Rao, MD, Phd University of Iowa
  More Information

Responsible Party: Satish SC Rao/Professor of Internal Medicine and Director of Neurogastroenterology and GI Motility, University of Iowa Identifier: NCT01300884     History of Changes
Other Study ID Numbers: 200705716
Study First Received: January 19, 2011
Last Updated: March 7, 2011

Additional relevant MeSH terms:
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 23, 2017