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Lower UTI Evaluation in Women With Uterine Leiomyomata

18 Years
Open (Enrolling)
Urinary Tract Infection, Leiomyoma

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Trial Information

Lower UTI Evaluation in Women With Uterine Leiomyomata

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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To measure prevalence of lower urinary tract symptoms including urinary incontinence symptoms in patients who present for care for symptomatic leiomyomata.

Outcome Time Frame:

Post treatment change

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Urinary Tract Infection
  • Leiomyoma
  • frequency
  • women
  • fibroids
  • uterine artery embolization
  • myomectomy
  • hysterectomy
  • Leiomyoma
  • Myofibroma
  • Urinary Tract Infections



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