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Uterine Artery Embolization and Pelvic Floor Symptoms

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00827645
Collaborator
(none)
0
Enrollment
1
Location
48
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Uterine artery embolization

    Women with symptomatic uterine fibroids scheduled for uterine artery embolization

    Outcome Measures

    Primary Outcome Measures

    1. Urinary symptoms as demonstrated by questionnaires [1 year]

    Secondary Outcome Measures

    1. Sexual dysfunction as defined by questionnaires [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT00827645
    Other Study ID Numbers:
    • 112008-033
    First Posted:
    Jan 23, 2009
    Last Update Posted:
    May 22, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:
    Leiomyoma
    Prolapse

    Study Results

    No Results Posted as of May 22, 2018