Uterine Artery Embolization and Pelvic Floor Symptoms

May 18, 2018 updated by: University of Texas Southwestern Medical Center

Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with symptomatic uterine fibroids who are scheduled for uterine artery embolization

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary symptoms as demonstrated by questionnaires
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Sexual dysfunction as defined by questionnaires
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Clifford Y Wai, MD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112008-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prolapse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe