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

This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01123603
First received: May 12, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Urinary Tract Infection
Leiomyoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lower UTI Evaluation in Women With Uterine Leiomyomata

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with urinary leakage and fibroids

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123603

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nathan Kow, MD     216-445-8090        
Principal Investigator: Nathan Kow, MD            
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01123603     History of Changes
Other Study ID Numbers: 09-923
Study First Received: May 12, 2010
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
frequency
women
fibroids
 uterine artery embolization
myomectomy
hysterectomy

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

ClinicalTrials.gov processed this record on May 16, 2013