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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01123603
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.

Condition or disease
Urinary Tract Infection Leiomyoma

Detailed 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.

Study Type : Observational
Actual Enrollment : 860 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lower UTI Evaluation in Women With Uterine Leiomyomata
Study Start Date : May 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To measure prevalence of lower urinary tract symptoms including urinary incontinence symptoms in patients who present for care for symptomatic leiomyomata. [ Time Frame: Post treatment change ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with urinary leakage and fibroids

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01123603

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Study Director: Matthew Barber, MMD The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT01123603     History of Changes
Other Study ID Numbers: 09-923
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by The Cleveland Clinic:
uterine artery embolization

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases