Uterine Artery Embolization and Pelvic Floor Symptoms | NCT00827645

Studies
Uterine Artery Embolization and Pelvic Floor Symptoms

NCT00827645

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

May 22, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Leiomyoma
Incontinence
Prolapse

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

never funded and never started

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Jan 1, 2013Actual

Completion Date

Jan 1, 2013Actual

First Submitted Date

Jan 21, 2009

First Submission Date that Met QC Criteria

Jan 21, 2009

First Posted Date

Jan 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2018

Last Update Posted Date

May 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Uterine artery embolization		Women with symptomatic uterine fibroids scheduled for uterine artery embolization

Interventions

Not provided

Measure	Description	Time Frame
Urinary symptoms as demonstrated by questionnaires		1 year

Measure	Description	Time Frame
Sexual dysfunction as defined by questionnaires		1 year

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clifford Y Wai, MD	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center		Dallas	Texas	75390	United States

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma
D011391	Prolapse

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided