Normal (no Known Injury) Anal Sphincter Female AnatomyNCT01123109
3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
A study testing 3-D Endoanal Ultrasound in people with Normal (no Known Injury) Anal Sphincter Female Anatomy, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal (no Known Injury) Anal Sphincter Female Anatomy
- What is being tested?
- 3-D Endoanal Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nulliparous women over the age of 18.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- 3-D Endoanal Ultrasound
- Keywords
- nulliparous women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D Endoanal UltrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| nulliparous females | Other | nulliparous women over the age of 18 Receives: Procedure: 3-D Endoanal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter.
Measured: 15 minute exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startDec 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal (no Known Injury) Anal Sphincter Female AnatomyStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Noblett, University of California, Irvine
- Investigators
- Karen Noblett, MD, Principal investigator, UCI Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123109
- Sponsor's protocol ID
- 2007-5983
- Status last verified
- Feb 2018
- First submitted
- 6 May 2010
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
- ClinicalTrials.gov ID
- NCT01123109
- Acronym / sponsor ID
- 2007-5983
- Keywords
- nulliparous women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nulliparous females | Other | Procedure: 3-D Endoanal Ultrasoundnulliparous women over the age of 18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nulliparous women over the age of 18.
Key exclusion criteria (1 listed)
- any history of anal incontinence, chronic constipation, anorectal disease or trauma, neuromuscular or neuropsychiatric disease, diabetes, gastrointestinal disorders, or previous anorectal or pelvic surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-D Endoanal UltrasoundThe 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. | Procedure or surgery | nulliparous females |
Primary outcome
To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter.
Time frame: 15 minute exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Noblett, MD principal investigator
UCI Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D Endoanal Ultrasound in people with Normal (no Known Injury) Anal Sphincter Female Anatomy, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter. (time frame: 15 minute exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.