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

Urinary Tract Infection Clinical Trial

— LOTUS  

Official title:

Lower UTI Evaluation in Women With Uterine Leiomyomata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123603
• Other study ID #: 09-923
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: January 13, 2015
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leiomyoma
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure prevalence of lower urinary tract symptoms including urinary incontinence symptoms in patients who present for care for symptomatic leiomyomata.		Post treatment change	No