www.criteriuminc.comOCTOBER 2009
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This Month's Clinical Focus: Urology

 Progress Made Toward Vaccine for Urinary Infections    
A vaccine to prevent urinary tract infections (against E. coli, a common cause) shows early promise in tests on mice, according to University of Michigan researchers. For two decades, researchers have been trying to develop a vaccine to prevent urinary tract infections, which afflict about 53 percent of women and 14 percent of men at least once in their lives, according to background information in a university news release.

The researchers screened more than 5,000 bacterial proteins and identified three strong candidates to use in a vaccine to fight Escherichia coli, the cause of most uncomplicated urinary tract infections. The new vaccine, administered in the nose, alerts the immune system to iron receptors on the surface of bacteria that play a major role in the spread of urinary tract infection. When tested in mice, the vaccine prevented infection and produced key types of immunity.

Each year in the United States, urinary tract infections lead to a large number of lost work days, 6.8 million medical office visits, 1.3 million emergency room visits and 245,000 hospitalizations, resulting in an estimated total annual cost of $2.4 billion, according to information from the university. The study appeared Sept. 18 in the journal PLoS Pathogens.

(SOURCE: University of Michigan, news release, Sept. 17, 2009)


NIDDK Announces Availability of
More Current Kidney Disease Data

Incidence and prevalence data for end-stage kidney disease in the United States will be available online from the U.S. Renal Data System
a year earlier than usual, announces the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. In addition, the data will be updated online every three months and will show quarterly counts of patients at www.usrds.org/qtr/qrt_report_table_new.html.

"These tables provide preliminary estimates, which may change minimally as additional updates become available," said Paul W. Eggers, Ph.D., who directs the NIDDK's kidney and urology epidemiology programs. "However, these frequent updates will allow researchers to see and investigate trends sooner than previously possible."

The first of the new tables shows incidence and prevalence counts through December 2008. As the tables are updated quarterly, an additional three months of counts will be added. The next update in December 2009 will include patient counts through March 2009.

Previously, incidence and prevalence data had been made available only through yearly updates of the USRDS Annual Data Report (www.usrds.org/adr.htm). Because the report includes detailed data from multiple sources, reporting lagged by about 18 months while data were merged and verified. For example, the 2009 report, which became available this month, has complete data only through 2007.


BY THE NUMBERS: URINARY INCONTINENCE

 The International Continence Society (ICS) defines incontinence as the "involuntary loss of bladder or bowel control."

Urinary Incontinence (UI) is a stigmatized, underreported, under-diagnosed, under-treated condition that is erroneously thought to be a
normal part of aging.   Information on healthy bladder function can help promote the understanding that incontinence is not a normal part of aging but a symptom of another problem. The social costs of UI are high and even mild symptoms affect social, sexual, interpersonal, and professional function.

Stress Incontinence:
- Stress urinary incontinence, the most prevalent form of incontinence among women, affects an estimated 15 million adult women in the U.S.
- 29% of individuals ages 60-70 experience leakage when coughing, sneezing, or laughing compared to 17% of men and women ages
30-39. A portion of these individuals also experience urge incontinence.
- Data from an NAFC survey shows that one-fourth of women older than 17 reportedly experienced stress incontinence during the
immediately preceding 30 days from being questioned. 24% of women ages 25-44 experienced symptoms compared to 33% of women ages 45-64.
- Studies have indicated that as many as 50% of men report leakage due to SUI in the first few weeks following prostate surgery after
removal of the catheter.
- In approximately 20% of men, some degree of SUI will continue to be a significant problem one year post-surgery.

General Prevalence:
- UI affects 200 million people worldwide.
- Based on expert opinion, 25 million adult Americans experience transient or chronic UI. 6 NAFC estimates that 75-80% of those sufferers
are women, 9-13 million of whom have bothersome, severe, symptoms.
- Consumer research reveals that one in four women over the age of 18 experience episodes of leaking urine involuntarily.
- One-third of men and women ages 30-70 have experienced loss of bladder control at some point in their adult lives and may be still living
with the symptoms.
- Of men and women ages 30-70 who awaken during the night to use the bathroom, more than one-third get up twice or more per night
to urinate, fitting the clinical diagnosis of nocturia. Of these adults, one in eight say they sometimes lose urine on the way to the bathroom.
- Two-thirds of men and women age 30-70 have never discussed bladder health with their doctor.
- One-third of men and women ages 30-70 believe that incontinence is a part of aging to accept.
- One in eight Americans who have experienced loss of bladder control have been diagnosed. Men are less likely to be diagnosed than
women. Men are also less likely to talk about it with friends and family, and are more likely to be uninformed.
- On average, women wait 6.5 years from the first time they experience symptoms until they obtain a diagnosis for their bladder control
problem(s).
- Two-thirds of individuals who experience loss of bladder control symptoms do not use any treatment or product to manage their
incontinence. (Source:  NAFC.org Media Statistics)


Change your workflow paradigm to transform your clinical trials into rapid, results-oriented studies. Criterium knows resources are precious, time is the enemy, and results are paramount. Our user-friendly technologies improve the efficiencies of all our clinical development services. Our talented, in-house staff is committed to the professional support of our clients needs.

Of particular interest to you would be our experience with UROLOGYCriterium has managed many studies in this important area, including: 
Urinary Incontinence, Urge Incontinence, Stress Incontinence, Stents, Erectile Dysfunction, & Chronic Renal Failure.

Get To Know Us!
We have several propriety technology solutions available that are proven to improve your clinical trial results. Contact John Hudak at
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WHAT'S NEW AT CRITERIUM:
 CRITERIUM, Inc. Global CRO Releases New Whitepaper
June 15, 2009

 
CRITERIUM, Inc. Global CRO Offers "A La Carte" Service Structure
April 15, 2009
   CRITERIUM, Inc. Global CRO Expands Services to Canada
February 2, 2009

WHITE PAPERS
   NEW!! Critical Clinical Research Factors in the Down Economy
By Lawrence Reiter, Ph.D.
   The Evolution of the Data Management Role: The Clinical Data Liaison
By Mary Stefanzick
   India: A Target-Rich Environment
By Ronny Schnel

VIDEOS
   NEW!!  The DIA 2009 Interview
Featuring Lawrence Reiter, Ph.D.

 
Addressing the Challenge of Finding Investigators for Clinical Trials
Featuring Kabelo Pududu
   The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak

PODCASTS
 

 NEW!!  Science is Greater than the Economy   
Featuring Lawrence Reiter, Ph.D.

 The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak

   Agile Clinical Trials and the Use of Real-Time Data
Featuring John M. Hudak

PUBLICATIONS
   NEW!! Maintaining Clinical Operations: It's Just Good Business - Lawrence Reiter, Ph.D.
PharmaVoice View on Clinical Operations
   EDC Implementation - Greg Bailey
PharmaVOICE, View on
E-Solutions
   Going Global - John M. Hudak
Future Pharmaceuticals
   Trials Limber Up - John M. Hudak
International Clinical Trials Magazine

PRESENTATION
   Criterium Capabilities Presentation

BROCHURE
   Criterium -
Connect - Communicate - Control

 

 

 


CRITERIUM wants you to know:
It is IC Awareness Week!
October 19-23 is the 2nd annual IC Awareness Week!!

IC Experts Discuss Merits of Current IC Diagnostic Options and Treatments
This article is available online & free-of-charge - CLICK HERE.

 

About Criterium Inc. (www.criteriuminc.com) is a global, full-service, and technology-driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, pharmaceutical, medical device, and CRO industries.

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