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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Normal (no Known Injury) Anal Sphincter Female Anatomy

Treatments

Procedure: 3-D Endoanal Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT01123109
2007-5983

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

nulliparous females
Other group
Description:
nulliparous women over the age of 18
Treatment:
Procedure: 3-D Endoanal Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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