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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827645
First Posted: January 23, 2009
Last Update Posted: February 18, 2010
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.
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
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.

Condition
Leiomyoma Incontinence Prolapse

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 ]

Secondary Outcome Measures:
  • Sexual dysfunction as defined by questionnaires [ Time Frame: 1 year ]

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)
Groups/Cohorts
Uterine artery embolization
Women with symptomatic uterine fibroids scheduled for uterine artery embolization

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Criteria

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
Information from the National Library of Medicine

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): NCT00827645


Contacts
Contact: Clifford Y Wai, MD 214-648-6430 clifford.wai@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Clifford Y Wai, MD    214-648-6430    clifford.wai@utsouthwestern.edu   
Principal Investigator: Clifford Y Wai, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Clifford Y Wai, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Clifford Wai, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00827645     History of Changes
Other Study ID Numbers: 112008-033
First Submitted: January 21, 2009
First Posted: January 23, 2009
Last Update Posted: February 18, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Prolapse
Leiomyoma
Pathological Conditions, Anatomical
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms