Incontinence, Leiomyoma, Prolapse
Conditions
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.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary symptoms as demonstrated by questionnaires | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Sexual dysfunction as defined by questionnaires | 1 year |
Countries
United States
Outcome results
None listed