Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata (LOTUS)
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|ClinicalTrials.gov Identifier: NCT01123603|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : January 14, 2015
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:
- To determine prevalence of lower urinary tract symptoms in patients who present for care for symptomatic leiomyomata.
- 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|
- 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.
- 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|
|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|
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01123603
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Matthew Barber, MMD||The Cleveland Clinic|