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Uterine Artery Embolization and Pelvic Floor Symptoms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: January 21, 2009
Last updated: February 17, 2010
Last verified: January 2010
The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Urinary symptoms as demonstrated by questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual dysfunction as defined by questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Uterine artery embolization
Women with symptomatic uterine fibroids scheduled for uterine artery embolization


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with symptomatic uterine fibroids who are scheduled for uterine artery embolization

Inclusion Criteria:

  • female
  • age 18-80 years
  • symptomatic uterine fibroids
  • scheduled for UAE
  • Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
  • Available for 12-months of follow-up and able to complete study assessments, per clinician judgment
  • Signed consent form

Exclusion Criteria:

  • Age <18 or >80 years
  • women who are unable to read and write English,
  • pregnancy or planned pregnancy in the next 12 months
  • < 6 months postpartum
  • current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
  • women with surgery for urinary incontinence or pelvic organ prolapse in the past 6 months
  • history of bladder or pelvic cancer or pelvic radiation therapy
  • prior augmentation cystoplasty
  • urethral diverticulum, current or repaired.
  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 identifier: NCT00827645

United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Clifford Y Wai, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Clifford Wai, University of Texas Southwestern Medical Center Identifier: NCT00827645     History of Changes
Other Study ID Numbers: 112008-033 
Study First Received: January 21, 2009
Last Updated: February 17, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms processed this record on December 09, 2016