Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata

Completed

Conditions studied: Urinary Tract Infection, Leiomyoma

In brief

To the investigators knowledge there is no research data published to date regarding the lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are: 1. To determine prevalence of lower urinary tract symptoms in patients who present for care for symptomatic leiomyomata. 2. To compare change in lower urinary tract symptoms within treatment groups measured by the UDI-6 total before and at six months after three common treatments for symptomatic uterine fibroids including: hysterectomy, myomectomy, or uterine artery embolization. The study proposed here will hopefully answer the question if one particular therapy is appropriate to treat fibroids and relieve lower urinary tract symptoms.

Key facts

Study ID

NCT01123603

Run by

The Cleveland Clinic

People needed

860

Starts

2010-05-01

Expected to finish

2014-06-01

Last updated by the study team

2015-01-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Patients who are at least 18 years of age,
• Vaginal bleeding secondary to anatomic uterine leiomyomas confirmed at the Cleveland Clinic Fibroid and Menstrual Disorders Center,
• Patients complaining of mass effect symptoms due to fibroids, and
• Patients undergoing either hysterectomy, myomectomy, or uterine artery embolization

You may not qualify if…

• Patients who are pregnant, or
• Diagnosis of solitary or multiple intracavitary fibroids without subserosal or intramural leiomyomas present, or
• Prior or interval anti-incontinence procedure, or
• Patients with a urinary tract infection, or
• Patients taking anti-cholinergic medications, or
• Presence of an adnexal mass, or
• Unable or unwilling to complete a follow up survey at six months following treatment

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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