Uterine Artery Embolization and Pelvic Floor Symptoms

This study is currently recruiting participants.

Verified by University of Texas Southwestern Medical Center, January 2009

First Received: January 21, 2009 No Changes Posted

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00827645

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

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	56
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (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:	University of Texas Southwestern Medical Center ( Clifford Wai )
Study ID Numbers:	112008-033, 5UL1RR024982-02 PACKER (PI)
Study First Received:	January 21, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00827645 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Neoplasms, Connective and Soft Tissue
Signs and Symptoms
Myofibroma
Urologic Diseases

Urination Disorders
Urinary Incontinence
Prolapse
Leiomyoma

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Signs and Symptoms
Urological Manifestations
Neoplasms

Neoplasms by Histologic Type
Urologic Diseases
Urination Disorders
Urinary Incontinence
Prolapse
Leiomyoma

ClinicalTrials.gov processed this record on May 06, 2009