Uterine Artery Embolization and Pelvic Floor Symptoms - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2009

Last Updated Date

January 21, 2009

Start Date ^†

January 2009

Current Primary Outcome Measures ^†

Urinary symptoms as demonstrated by questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Sexual dysfunction as defined by questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Uterine Artery Embolization and Pelvic Floor Symptoms

Official Title ^†

Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Leiomyoma
Incontinence
Prolapse

Intervention ^†

Study Arms / Comparison Groups

Women with symptomatic uterine fibroids scheduled for uterine artery embolization

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

January 2011

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Clifford Y Wai, MD

214-648-6430

clifford.wai@utsouthwestern.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827645

Responsible Party

Clifford Wai, University of Texas Southwestern Medical Center

Secondary IDs ^††

5UL1RR024982-02 PACKER (PI)

Study Sponsor ^†

University of Texas Southwestern Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Clifford Y Wai, MD

University of Texas Southwestern Medical Center

Information Provided By

University of Texas Southwestern Medical Center

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.