Nulliparous WomenNCT00964145
Effects of Age on the Levator Ani Muscle of Nulliparous Women
An observational study of Nulliparous Women, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of the study is to characterize the levator ani structures (pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography in nulliparous women 21-70 years old. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nulliparous Women
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2011
- Phase
- Observational
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling nulliparous females, ages 21-70 years. Women are eligible for participation if they are willing to undergo a physical examination regardless of race, continence or prolapse status.
Who may be able to join
- Nulliparous female patients ages 21-70 years old
Who cannot join
- History of prior incontinence, or prolapse surgery
- Diagnosis of reproductive tract anomalies
- Prior pelvic radiation therapy
- Hysterectomy
- Unable to complete written questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
The purpose of the study is to characterize the levator ani structures (pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography in nulliparous women 21-70 years old.
Hypothesis 1: Prevalence of abnormalities in levator ani muscle structure will be associated with increasing age independent of vaginal parity. To investigate the age-related symptoms of pelvic floor dysfunction in nulliparous, women 21-70 years old.
Read more
Hypothesis 2: Anatomical abnormalities of the levator ani muscles will be associated with symptomatic pelvic floor dysfunction. To investigate the age-related pelvic floor function in nulliparous, women 21-70 years old.
Hypothesis 3: Age-related anatomical abnormalities of the levator ani muscles will be associated with levator ani muscle weakness.
Read the detailed description
This is a a cross-sectional study of age-related changes in the levator ani muscles. We will explore the 3-D anatomical architecture of these muscles in asymptomatic females ages 21-70 years old. Subjects who meet eligibility criteria will be scheduled to have a clinic study visit during which informed consent will be obtained. At this visit, subjects will be asked to complete self administered pelvic floor symptom and impact measures questionnaire (PFDI, PFIQ and PISQ-12), as well as the quality of life measure (SF-12). At the clinic study visit, a complete history will be obtained including the subject's gynecologic history including age, menopausal status, medical and surgical history by interview. A standardized examination will performed, including height, weight, and pelvic floor support assessment by using the pelvic organ prolapse quantification system (POP-Q). Body mass index will be calculated. Levator function will be assessed using the instrumented vaginal speculum. Vaginal closure force will be measured at both rest and during maximal voluntary contraction. At the completion of the exam and speculum examinations, all participants will then undergo an endovaginal 3-D ultrasound (BK medical, Wilmington, MA), at the study visit. The endovaginal ultrasound technique has been described previously. The technique is summarized as follows: A length of six cm will be scanned in 60 seconds at scans every 0.25 mm with a cumulative 240 scans from which a 3-D rendered cube will be calculated. Each 3-D cube will be digitally catalogued for future analysis. The ultrasound cubes will then be reviewed by two reviewers (LHQ and SAS), blinded to the identity of volunteers or the scores of the other reviewer. Reviewers will score muscles based on the individual muscle visualization by the origin - insertion points. The levator ani muscles in these scans will be examined for the visibility of the puboperinealis, puboanalis and pubovaginalis divisions of the levator ani muscle. Other structures, such as the superficial transverse perinei, puborectalis and iliococcygeous muscle will also be identified. A scoring system was previously developed according to the morphology and clarity of the each subdivision's origin-insertion points. The characteristic features of each levator subdivision will determined by the following two criteria: A clear and visible separation between each adjacent structure, or, Differing origin-insertion points of the muscle. An exemplary scan of a 25 year-old nulliparous women has been selected for image clarity based on the described classification method. According to the scoring system, a score of 0 given to each muscle pair corresponds to "no muscle damage" and a score of 18 corresponds to "complete muscle loss" of all subdivisions. Next, a 3-D PowerPoint library will be created describing the structures that need to be identified. The blinded reviewer may confirm the identity of the structure by manipulating the planes on the 3-D cube to trace the entire muscle subdivision to look for origin-insertion points.
- Conditions
- Nulliparous Women
- Keywords
- Nulliparous women, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous female patients | Nulliparous female patients ages 21-70 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the levator ani structures (pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography in nulliparous women 21-70 years old.
Measured: August 2011
To investigate the age-related pelvic floor dysfunction in nulliparous women 21-70 years old.
Measured: August 2011
To investigate the age-related pelvic floor function in nulliparous, women 21-70 years old.
Measured: August 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nulliparous WomenStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- Lieschen H. Quiroz, M.D., Principal investigator, University of Oklahoma Health Sciences Center/Medicine/OB/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964145
- Sponsor's protocol ID
- 14723 Nulliparous Women
- Status last verified
- Jun 2011
- First submitted
- 21 Aug 2009
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Age on the Levator Ani Muscle of Nulliparous Women
- ClinicalTrials.gov ID
- NCT00964145
- Acronym / sponsor ID
- 14723 Nulliparous Women
- Conditions
- Nulliparous Women
- Keywords
- Nulliparous women, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Aug 2009 (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 the study is to characterize the levator ani structures (pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography in nulliparous women 21-70 years old.
Hypothesis 1: Prevalence of abnormalities in levator ani muscle structure will be associated with increasing age independent of vaginal parity. To investigate the age-related symptoms of pelvic floor dysfunction in nulliparous, women 21-70 years old.
Hypothesis 2: Anatomical abnormalities of the levator ani muscles will be associated with symptomatic pelvic floor dysfunction. To investigate the age-related pelvic floor function in nulliparous, women 21-70 years old.
Hypothesis 3: Age-related anatomical abnormalities of the levator ani muscles will be associated with levator ani muscle weakness.
Detailed description
This is a a cross-sectional study of age-related changes in the levator ani muscles. We will explore the 3-D anatomical architecture of these muscles in asymptomatic females ages 21-70 years old. Subjects who meet eligibility criteria will be scheduled to have a clinic study visit during which informed consent will be obtained. At this visit, subjects will be asked to complete self administered pelvic floor symptom and impact measures questionnaire (PFDI, PFIQ and PISQ-12), as well as the quality of life measure (SF-12). At the clinic study visit, a complete history will be obtained including the subject's gynecologic history including age, menopausal status, medical and surgical history by interview. A standardized examination will performed, including height, weight, and pelvic floor support assessment by using the pelvic organ prolapse quantification system (POP-Q). Body mass index will be calculated. Levator function will be assessed using the instrumented vaginal speculum. Vaginal closure force will be measured at both rest and during maximal voluntary contraction. At the completion of the exam and speculum examinations, all participants will then undergo an endovaginal 3-D ultrasound (BK medical, Wilmington, MA), at the study visit. The endovaginal ultrasound technique has been described previously. The technique is summarized as follows: A length of six cm will be scanned in 60 seconds at scans every 0.25 mm with a cumulative 240 scans from which a 3-D rendered cube will be calculated. Each 3-D cube will be digitally catalogued for future analysis. The ultrasound cubes will then be reviewed by two reviewers (LHQ and SAS), blinded to the identity of volunteers or the scores of the other reviewer. Reviewers will score muscles based on the individual muscle visualization by the origin - insertion points. The levator ani muscles in these scans will be examined for the visibility of the puboperinealis, puboanalis and pubovaginalis divisions of the levator ani muscle. Other structures, such as the superficial transverse perinei, puborectalis and iliococcygeous muscle will also be identified. A scoring system was previously developed according to the morphology and clarity of the each subdivision's origin-insertion points. The characteristic features of each levator subdivision will determined by the following two criteria: A clear and visible separation between each adjacent structure, or, Differing origin-insertion points of the muscle. An exemplary scan of a 25 year-old nulliparous women has been selected for image clarity based on the described classification method. According to the scoring system, a score of 0 given to each muscle pair corresponds to "no muscle damage" and a score of 18 corresponds to "complete muscle loss" of all subdivisions. Next, a 3-D PowerPoint library will be created describing the structures that need to be identified. The blinded reviewer may confirm the identity of the structure by manipulating the planes on the 3-D cube to trace the entire muscle subdivision to look for origin-insertion points.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nulliparous female patients | – | –Nulliparous female patients ages 21-70 years old. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling nulliparous females, ages 21-70 years. Women are eligible for participation if they are willing to undergo a physical examination regardless of race, continence or prolapse status.
Key inclusion criteria (1 listed)
- Nulliparous female patients ages 21-70 years old
Key exclusion criteria (5 listed)
- History of prior incontinence, or prolapse surgery
- Diagnosis of reproductive tract anomalies
- Prior pelvic radiation therapy
- Hysterectomy
- Unable to complete written questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To characterize the levator ani structures (pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography in nulliparous women 21-70 years old.
Time frame: August 2011
To investigate the age-related pelvic floor dysfunction in nulliparous women 21-70 years old.
Time frame: August 2011
To investigate the age-related pelvic floor function in nulliparous, women 21-70 years old.
Time frame: August 2011
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 28 Jun 2011.
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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.
Lieschen H. Quiroz, M.D. principal investigator
University of Oklahoma Health Sciences Center/Medicine/OB/GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nulliparous Women, run by University of Oklahoma 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 5 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 28 Jun 2011. 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 characterize the levator ani structures (pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeous) using 3-D ultrasonography in nulliparous women 21-70 years old. (time frame: August 2011). The study lists 3 primary outcomes in all. 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 28 Jun 2011.