UCI Women's Healthcare
Orange, California, 92868, United States
Completed
NCT Number: NCT01123109
3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
3-D Endoanal Ultrasound
ProcedureThe 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.
Primary outcomes
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To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter.
Time frame: 15 minute exam
Sponsors and collaborators
Lead sponsor
University of California, Irvine
Other
Registry information
Important dates
- Study start
- 2007
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 14, 2010
- Registry last updated
- Feb 7, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.