Uterine Artery Embolization and Pelvic Floor Symptoms
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Texas Southwestern Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Texas Southwestern Medical Center
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00827645
First received: January 21, 2009
Last updated: February 17, 2010
Last verified: January 2010
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Purpose
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.
| Condition |
|---|
|
Leiomyoma Incontinence Prolapse |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction |
Further study details as provided by University of Texas Southwestern Medical Center:
Primary Outcome Measures:
- Urinary symptoms as demonstrated by questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sexual dysfunction as defined by questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Uterine artery embolization
Women with symptomatic uterine fibroids scheduled for uterine artery embolization
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Women with symptomatic uterine fibroids who are scheduled for uterine artery embolization
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827645
Contacts
| Contact: Clifford Y Wai, MD | 214-648-6430 | clifford.wai@utsouthwestern.edu |
Locations
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clifford Y Wai, MD 214-648-6430 clifford.wai@utsouthwestern.edu | |
| Principal Investigator: Clifford Y Wai, MD | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
| Principal Investigator: | Clifford Y Wai, MD | University of Texas Southwestern Medical Center |
More Information
No publications provided
| Responsible Party: | Clifford Wai, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00827645 History of Changes |
| Other Study ID Numbers: | 112008-033 |
| Study First Received: | January 21, 2009 |
| Last Updated: | February 17, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Prolapse Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013