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

NCT01123109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-02-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Karen Noblett, MD · UCI Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123109 on ClinicalTrials.gov