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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01123603
Study type	Observational
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	N/A
Start date	May 2010
Completion date	June 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03235947` - Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients	Phase 4
Withdrawn	`NCT01881165` - Cranberry on Urinary Tract Infections	Phase 4
Terminated	`NCT02198833` - Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection	N/A
Completed	`NCT02357758` - Effects of Antibiotic Prophylaxis on Recurrent UTI in Children	Phase 4
Completed	`NCT01687114` - Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products	N/A
Completed	`NCT01391793` - Corticosteroids for Children With Febrile Urinary Tract Infections	Phase 3
Completed	`NCT01219595` - Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women	N/A
Completed	`NCT00365430` - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes	N/A
Recruiting	`NCT04502095` - Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	Phase 4
Completed	`NCT00976963` - Single Dose Monurol for Treatment of Acute Cystitis	N/A
Recruiting	`NCT02568800` - Prolonged Infusion Cefepime and Nosocomial Infections	Phase 3
Completed	`NCT02785445` - Healthy.io Method Comparison & User Performance Study	N/A
Completed	`NCT02216253` - L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.	N/A
Completed	`NCT01478620` - Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)	Phase 3
Completed	`NCT01054690` - Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)	N/A
Completed	`NCT00371631` - Colonizing Neurogenic Bladders With Benign Flora	Phase 1
Terminated	`NCT03697993` - Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)	Phase 4
Terminated	`NCT01803919` - Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients	N/A
Enrolling by invitation	`NCT01231737` - Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)	Phase 2
Completed	`NCT01763008` - A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms