Uterine Artery Embolization and Pelvic Floor Symptoms

NCT ID: NCT00827645

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2013-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leiomyoma Incontinence Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Uterine artery embolization

Women with symptomatic uterine fibroids scheduled for uterine artery embolization

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clifford Y Wai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

112008-033

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of Uterine Artery Embolization in Adenomyosis
NCT05597644 NOT_YET_RECRUITING EARLY_PHASE1