Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01123603
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2010-05-12
Brief Title:
Lower Urinary Tract Infection UTI Evaluation in Women With Uterine Leiomyomata
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Lower UTI Evaluation in Women With Uterine Leiomyomata
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTUS
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
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
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 hysterectomy1-3 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
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 hysterectomy1-3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None