Uterine Artery Embolization and Pelvic Floor Symptoms

Incontinence Clinical Trial

Official title:

Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00827645
• Other study ID #: 112008-033
• Status: Withdrawn
• Start date: January 1, 2009
• Est. completion date: January 1, 2013

Study information

• Verified date: May 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2013
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Incontinence
• Leiomyoma
• Prolapse

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary symptoms as demonstrated by questionnaires		1 year
Secondary	Sexual dysfunction as defined by questionnaires		1 year