Effects of Age on the Levator Ani Muscle of Nulliparous Women

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00964145
First received: August 21, 2009
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition
Nulliparous Women

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Effects of Age on the Levator Ani Muscle of Nulliparous Women

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To investigate the age-related pelvic floor dysfunction in nulliparous women 21-70 years old. [ Time Frame: August 2011 ] [ Designated as safety issue: No ]
  • To investigate the age-related pelvic floor function in nulliparous, women 21-70 years old. [ Time Frame: August 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nulliparous female patients
Nulliparous female patients ages 21-70 years old.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Nulliparous female patients ages 21-70 years old

Exclusion Criteria:

  • History of prior incontinence, or prolapse surgery
  • Diagnosis of reproductive tract anomalies
  • Prior pelvic radiation therapy
  • Hysterectomy
  • Unable to complete written questionnaires
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964145

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Lieschen H. Quiroz, M.D. University of Oklahoma Health Sciences Center/Medicine/OB/GYN
  More Information

No publications provided

Responsible Party: Lieschen H. Quiroz, M.D., University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00964145     History of Changes
Other Study ID Numbers: 14723 Nulliparous Women
Study First Received: August 21, 2009
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Nulliparous women
ultrasound

ClinicalTrials.gov processed this record on July 28, 2014