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

NCT01123109 | Completed DMC

• 1 other identifier: 2007-5983
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal (no Known Injury) Anal Sphincter Female Anatomy

Keywords

nulliparous women

Outcome Measures

Primary Outcomes (1)

• To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter.

  15 minute exam

Study Arms (1)

nulliparous females

OTHER

nulliparous women over the age of 18

Procedure: 3-D Endoanal Ultrasound

Interventions

3-D Endoanal Ultrasound 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.

nulliparous females

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nulliparous women over the age of 18.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Women's Healthcare

Orange, California, 92868, United States

Location

Study Officials

• Karen Noblett, MD

  UCI Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 14, 2010
• Study Start: December 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

US (1)