Uterine Artery Embolization and Pelvic Floor Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00827645
First received: January 21, 2009
Last updated: February 17, 2010
Last verified: January 2010
  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 ] [ 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)
Groups/Cohorts
Uterine artery embolization
Women with symptomatic uterine fibroids scheduled for uterine artery embolization

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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

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

No publications provided

Responsible Party: Clifford Wai, University of Texas Southwestern Medical Center
ClinicalTrials.gov 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:
Leiomyoma
Myofibroma
Prolapse
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014