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3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females

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ClinicalTrials.gov Identifier: NCT01123109
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Noblett, University of California, Irvine

Brief Summary:
The purpose of this research study is to measure the muscles that make up your anal sphincter (muscles that control bowel movements) by using ultrasound. The most common way for women to injure these muscles is through childbirth. Some physicians think about 30% of women delivering their first baby develop some anal sphincter damage, which may or may not lead to symptoms such as anal urgency or incontinence (involuntary loss of gas or stool). The purpose of the study is to measure muscles in normal women who have never given birth or had an injury to their anal sphincter.

Condition or disease Intervention/treatment Phase
Normal (no Known Injury) Anal Sphincter Female Anatomy Procedure: 3-D Endoanal Ultrasound Not Applicable

Detailed Description:

Participants will be asked to complete a one page questionnaire. This questionnaire will address whether perineal trauma, sphincter lacerations, anal incontinence, and fecal urgency impact the subject on any level. Subjects will also be asked about their bowel habits and history of problems with bowel movements. Subjects will then be asked to undergo an ultrasound study of the anal sphincter at the time of enrollment. Completing the entire study will take no more than 15 minutes. This will be done at the doctor's office. Answering the questionnaire will take no more than 5 minutes.

The endoanal ultrasound is a probe with a diameter equivalent to the index finger. It is inserted in the rectum and measures the length and width of the sphincter muscles.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
Study Start Date : December 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
nulliparous females
nulliparous women over the age of 18
Procedure: 3-D Endoanal Ultrasound
The subject will be placed in the supine position with their feet in the stirrups and a drape will be used, exposing only the anus and perineum in order to introduce the probe. In order to prevent and minimize any potential discomfort, the lubricated ultrasound probe will be gently inserted into the anal canal up to the anal verge, with minimal manipulation of the probe once inserted. The scan lasts approximately two minutes and the entire exam will take no more than five minutes.



Primary Outcome Measures :
  1. To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter. [ Time Frame: 15 minute exam ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • nulliparous women over the age of 18.

Exclusion Criteria:

  • any history of anal incontinence, chronic constipation, anorectal disease or trauma, neuromuscular or neuropsychiatric disease, diabetes, gastrointestinal disorders, or previous anorectal or pelvic surgeries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123109


Locations
United States, California
UCI Women's Healthcare
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen Noblett, MD UCI Medical Center

Responsible Party: Karen Noblett, Division Director, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01123109     History of Changes
Other Study ID Numbers: 2007-5983
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Karen Noblett, University of California, Irvine:
nulliparous women