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Uterine Artery Embolization and Pelvic Floor Symptoms

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ClinicalTrials.gov Identifier: NCT00827645
Recruitment Status : Withdrawn (never funded and never started)
First Posted : January 23, 2009
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
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 or disease
Leiomyoma Incontinence Prolapse

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : January 1, 2013
Actual Study Completion Date : January 1, 2013

Group/Cohort
Uterine artery embolization
Women with symptomatic uterine fibroids scheduled for uterine artery embolization



Primary Outcome Measures :
  1. Urinary symptoms as demonstrated by questionnaires [ Time Frame: 1 year ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

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


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

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00827645     History of Changes
Other Study ID Numbers: 112008-033
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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