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Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction


N/A
18 Years
80 Years
Open (Enrolling)
Female
Leiomyoma, Incontinence, Prolapse

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Trial Information

Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Urinary symptoms as demonstrated by questionnaires

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Clifford Y Wai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center

Authority:

United States: Institutional Review Board

Study ID:

112008-033

NCT ID:

NCT00827645

Start Date:

January 2009

Completion Date:

January 2013

Related Keywords:

  • Leiomyoma
  • Incontinence
  • Prolapse
  • Leiomyoma
  • Myofibroma
  • Prolapse

Name

Location

University of Texas Southwestern Medical CenterDallas, Texas