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

NCT ID: NCT01123109

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Normal (no Known Injury) Anal Sphincter Female Anatomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

nulliparous females

nulliparous women over the age of 18

Group Type: OTHER

3-D Endoanal Ultrasound

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Karen Noblett

Division Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Noblett, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Medical Center

Locations

UCI Women's Healthcare

Orange, California, United States

Countries

United States

Other Identifiers

2007-5983

Identifier Type: -

Identifier Source: org_study_id