3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01123109|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Normal (no Known Injury) Anal Sphincter Female Anatomy||Procedure: 3-D Endoanal Ultrasound||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
nulliparous women over the age of 18
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.
- To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter. [ Time Frame: 15 minute exam ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123109
|United States, California|
|UCI Women's Healthcare|
|Orange, California, United States, 92868|
|Principal Investigator:||Karen Noblett, MD||UCI Medical Center|