Uterine Artery Embolization and Pelvic Floor Symptoms
Withdrawn
- Conditions
- ProlapseLeiomyomaIncontinence
- Registration Number
- NCT00827645
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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 available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Urinary symptoms as demonstrated by questionnaires 1 year
- Secondary Outcome Measures
Name Time Method Sexual dysfunction as defined by questionnaires 1 year
Trial Locations
- Locations (1)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States