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



Status:Recruiting
Conditions:Cancer, Infectious Disease, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:May 2010

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Lower UTI Evaluation in Women With Uterine Leiomyomata

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.

1. Uterine fibroids Uterine leiomyomas or fibroids are one of the most common conditions
affecting women of reproductive age. They account for approximately a third of all
hysterectomies performed. Symptoms often attributed to uterine leiomyomas include
excessive menstrual bleeding, dysmenorrhea, pelvic pain, and so called "bulk symptoms,"
or symptoms related to pressure on adjacent organs such as ureteral obstruction,
urinary frequency and urgency, rectal pressure, pelvic pressure and increasing
abdominal girth. Current treatment for symptomatic uterine fibroids includes
hysterectomy, myomectomy and uterine fibroid embolization.

2. Lower urinary tract symptoms Although, urinary symptoms like frequency, urgency,
incontinence, and voiding dysfunction are often attributed to fibroids, the
relationship between fibroids and lower urinary tract symptoms (LUTS) has been poorly
studied. The public health burden of fibroids has been studied before and after
radical hysterectomy, supracervical hysterectomy, and total abdominal
hysterectomy.(1-3) What is missing in the literature is a comparison of traditional
and non-traditional surgical fibroid techniques in a prospective fashion. Moreover,
there are no studies evaluating the relationship between anatomic factors like uterine
size or fibroid number or location and the presence of LUTS.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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