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

Not Applicable

Completed

• Conditions: Normal (no Known Injury) Anal Sphincter Female Anatomy
• Interventions: Procedure: 3-D Endoanal Ultrasound

• Registration Number: NCT01123109
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nulliparous females	3-D Endoanal Ultrasound	nulliparous women over the age of 18

Primary Outcome Measures

Name	Time	Method
To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter.	15 minute exam

Trial Locations

Locations (1)

UCI Women's Healthcare; 🇺🇸 Orange, California, United States