SPRING 2012 A publication of the American Urological Association Foundation.
E D UCAT I O N Bladder Health Quiz Incontinence: Taking Back Control
A DVO CA CY National Association For Continence: A Key Voice
R ES EA R CH What are Clinical Trials?
R EGU L A R FEATURES Foundation Focus: It’s Time to Talk About OAB Ask a Urologist
Incontinence:
Taking Back Control
UrologyHealth Extra® is published by the American Urological Association Foundation as a service to patients, physicians and the public. To receive this newsletter, call 1-800-828-7866 or visit www.UrologyHealth.org Editor Mike Sheppard Executive Director Managing Editors Dana Gugliuzza Alaina Willing Contributing Writers Cynthia Duncan Sarah Elder Kimberly Miller Alaina Willing Editorial Board Wendy Waldsachs Isett Communications Manager Deborah Polly Publications Director For comprehensive urological information, visit www.UrologyHealth.org The American Urological Association Foundation believes the information in this publication is as authoritative and accurate as is reasonably possible and that sources of information used in preparation are reliable, but no assurance or warranty of completeness or accuracy is intended or given, and all warranties of any kind are disclaimed. All articles in this newsletter have been medically reviewed, but because every patient is unique, personal questions and concerns about any of the content included here and its application to the patient should be discussed with a urologist. To locate a urologist in your area, visit www. UrologyHealth.org. The AUA Foundation has no preference or bias concerning any specific tests, products, procedures, opinions or other information mentioned herein.
Bladder Health Quiz 1. The bladder is the part of the urinary tract that: a. creates urine b. stores urine c. prevents dehydration 2. Urinary incontinence, the inability to hold one’s urine, is normal as a person gets older. True or False?
6. Women are more likely than men to get bladder cancer. True or False? 7. The most common symptom of bladder cancer is: a. no urination b. blood in the urine c. pain in pelvic region
3. Bladder cancer is extremely rare in the United States. True or False?
8. Stress urinary incontinence (SUI): a. affects only women b. can be caused by laughing or sneezing c. can only be treated by surgery
4. Smoking doubles your risk of getting bladder cancer. True or False?
Answers on page 7.
5. A urinary tract infection (UTI) refers to a condition in which bacteria are growing in the: a. bladder b. kidneys c. bladder or kidneys
New Resources on UrologyHealth.org New Patient Alerts
Have you heard about a urologic health topic in the news recently? Want to learn more about FDA alerts, new research and other timely issues in urologic health? Check out our new Patient Alerts feature on UrologyHealth.org under “News & Resources.”
Access Benefits, Support Groups and Resources for Caregivers
Are you caring for a loved one? In recognition of those that selflessly devote countless time and energy caring for others, the AUA Foundation has compiled a list for caregivers and others to access planning guides, government benefits, support groups, prescription assistance and additional resources. Check it out on UrologyHealth.org under “Outreach.”
EDUCATION
ASK A UROLOGIST
Q
My urologist recommended implantation of
A
synthetic vaginal mesh to treat my severe pelvic organ prolapse (POP). While I am not experiencing any complications from my surgery, I am very concerned because of the recent reports surrounding the use of vaginal mesh for pelvic organ prolapse repair. What should I do? Pelvic organ prolapse is the weakening of the pelvic organ tissues, resulting in “sagging” or dropping of the bladder, uterus or rectum into the vaginal opening. It can occur due to the natural aging process, childbirth or menopause. While symptoms associated with the condition vary, many women feel pressure in the pelvic area, and often experience bladder and anal incontinence issues. It is important to understand that not all patients who have been treated with vaginal mesh will have complications. There is no reason to remove mesh if the outcome is successful and you are not experiencing complications. Additionally, certain complications can occur after any surgery for POP, whether or not mesh was used. If you are experiencing vaginal bleeding or discharge, sexual dysfunction, urinary tract infection (UTI), pain in the pelvic or groin area, or erosion, which is when the mesh protrudes into the vagina, you should speak to your doctor. A possible solution is to remove the mesh surgically, but other non-surgical interventions may also correct the problem. If you are not experiencing any of these symptoms, you may continue with your routine scheduled care. However, it is very important to be aware of the possible complications and carefully follow postoperative instructions, see your physician for scheduled checkups and contact your physician if you experience any problems. The AUA and AUA Foundation have released statements on this topic. For more information on the issue, visit UrologyHealth.org.
Q
I keep getting urinary tract infections (UTIs). What can I do to treat them and how do I avoid getting UTIs in the future?
A
If you are having recurrent UTIs (three or more per year), you should see your healthcare provider, who may recommend that you have a urine culture test. This test will determine the type of bacteria that is causing the UTI and ensure that your prescribed antibiotics are adequate to treat the infection. If you continue to have UTIs and have been taking antibiotics, your doctor may recommend that you continue taking the antibiotic but at a low dosage. You may also need to undergo additional tests, such as an ultrasound, CT scan or cystoscopy. These tests will examine the bladder and urinary tract for structural abnormalities or obstructions that could be causing your UTIs.
There are some simple steps you can take to prevent UTIs. For instance, your doctor may emphasize the importance of staying hydrated by drinking plenty of fluids. When you feel the need to urinate, you should, because holding your bladder can increase your chance for infections. Wiping front to back can prevent the introduction of bacteria into the vagina or urethra, decreasing your risk for developing a UTI. While these steps may be beneficial to help you overcome UTIs, there is no scientific evidence that they will permanently decrease your risk of developing a UTI.
You may also need to change your contraception. Women who use spermicidal foams for birth control are at an increased risk for UTIs. Urinating after sexual intercourse may decrease your risk of infection because the urine flushes out bacteria that may have been introduced during intercourse. Furthermore, your doctor may recommend a dose of antibiotics after intercourse, also known as periintercourse prophylaxis, to help prevent UTI recurrence.
For women who have gone through menopause and have lost normal estrogen output, using estrogen replacement has been shown to help prevent UTIs. However, since not all women can take estrogen replacement, you should contact your doctor before starting any form of hormonal therapy. u
Have a urologic question you’d like answered in the next issue of UrologyHealth Extra®? Send us your question at AUAFoundation@AUAFoundation.org. www.UrologyHealth.org
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FEATURES
FOUNDATION FOCUS
IT’S TIME
TO TALK
ABOUT OAB AUA Foundation Launches New “Urology for Women” Initiative Each year, millions of men and women in the United States suffer from overactive bladder (OAB), also known as urge incontinence, an often debilitating and highly stigmatized condition in which patients experience leakage, sudden urges to urinate and/or frequent urination. Sadly, statistics show that many women wait up to 10 years before discussing their OAB problems with their healthcare providers. This delay can negatively affect their quality of life and lead to more serious medical conditions. Due to the sensitive, and possibly embarrassing, nature of the subject, many women do not feel comfortable asking for help, and many physicians do not automatically talk about this issue with their patients. As the official Foundation of the American Urological Association (AUA) – the foremost authority on urologic conditions such as OAB, the AUA Foundation speaks on behalf of patients everywhere and is uniquely positioned to authoritatively change the dialogue around this issue. To help the one in six adults who suffers from OAB, the Foundation is expanding its “Urology for Women” initiative by launching a broad-scale program to raise public health awareness about OAB and to start the conversation between women and their healthcare providers. Through the “It’s Time to Talk About OAB” campaign, we hope to elevate this issue, provide expert recommendations for the public and patients, and promote discussion and greater understanding of OAB. As we roll out the campaign in May, the AUA Foundation would like to recognize the generosity of Astellas Pharma US, Inc. for its educational grant to support these efforts.
To find out more, visit UrologyHealth.org today. u
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COVER STORY
Incontinence: Taking Back Control Forty-year-old Ellen* has a busy life. She is the proud mom of three boys 6 to 16 years old, an avid runner and triathlete, and works for a financial institution. She also used to suffer from urinary incontinence, a condition that almost put her life in danger.
n men and a ic r e m A n 15 millio ence, More than from urinary incontin fer e, and n i r u f o women suf ntal loss e d i c c a e th omen. w e r a t n e c 85 per
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www.UrologyHealth.org
COVER STORY
Ellen began to experience symptoms of incontinence after the birth of her second son in 1999 when she was only 28 years old. She would experience urine leakage because she didn’t feel the urge to urinate in time to get to the bathroom. “The first time it happened, I was surprised and devastated; I didn’t know that could happen. But I had just given birth to a 10-pound baby and I have a small frame, so I chalked it up to my son’s size,” she said. A few months later the symptoms subsided, so she thought little of it and went on with her life. “But it became a problem again when I started running.” Ellen loves to run, and has participated in several triathlons since 2002. She started training intensely in 2004 between the births of her second and third sons. She experienced leakage when she was running due to stress urinary incontinence (SUI), which involves involuntary loss of urine that occurs when pressure on the bladder is increased during physical movement of the body. The symptoms increased in severity after the birth of her third son in 2005, but Ellen was determined to keep running. “The problem was, I was trying to avoid it and I hadn’t gone to the doctor,” Ellen explained. In July 2006, she was registered to participate in a race in her hometown. “I didn’t want to have to deal with leakage, especially there, in that race in front of everyone I knew.” In an effort to prevent incontinence symptoms, Ellen did not drink any liquids the previous day or the morning of the race. Unfortunately, it was unseasonably warm for Washington state; Ellen’s thermometer read 80 degrees at only 8 a.m. Ellen’s attempt to avoid leakage during the race and the hot weather culminated in a severe case of dehydration. “It was absolutely terrifying; I felt like I could have died,” she reported. “That was the day I decided to do something to change my life.”
Ellen was referred to American Urological Association (AUA) member urologist and “It’s Time to Talk About SUI” panel member Dr. Kathleen Kobashi at Virgina Mason Medical Center. At first, Ellen was concerned that treatment for urinary incontinence would impose on her active and busy lifestyle, but Dr. Kobashi assured her that she would find a solution that would allow her to continue to care for her family and keep running. Dr. Kobashi performed a surgical procedure to insert a “sling” under the urethra, and now Ellen no longer experiences SUI. In November 2011 Ellen completed the Seattle half marathon with her best friend and her oldest son. At the time of this writing, she is training five days a week to participate in a 50K run this spring. Ellen’s case is not uncommon. More than 15 million American men and women suffer from urinary incontinence, the accidental loss of urine, and 85 percent are women. While the risk of developing incontinence increases proportionally with age, young women like Ellen also frequently experience it. According to Dr. Kobashi, “there’s a huge misconception that only the elderly suffer from incontinence, but in fact, I see a lot of women in their 30s and 40s.” Another myth is that incontinence is “just a normal part of aging.” When a person suffers from incontinence, there is a huge negative impact on his or her quality of life. Some people quit their jobs, avoid participating in activities they enjoy, stop exercising and avoid social situations to prevent experiencing leakage in public. Rose is a 61-year-old human resources executive, mother and grandmother who loves to travel and has done so extensively across North America and Europe. She also loves to exercise and power-walks twice a day up and down the steep hills of Seattle, even through rain and snow. When Rose began experiencing SUI about 15 years ago, it had a huge impact on her ability to work and do what she loved. “I would walk a few blocks and all of a sudden I was wet clear down to my knees. I was just gushing. It got to the point where I couldn’t make it to the
bathroom at my office on time. That was an everyday occurrence.” Diagram of female bladder with strong pelvic muscles
Diagram of female bladder with weak pelvic muscles
“The ironic thing is, we tell patients to get out there and exercise, that a healthy, active lifestyle helps prevent incontinence, but a patient may not want to go out for a run because they fear they will have leakage,” reports AUA member urologist and “It’s Time to Talk About SUI” panel member Dr. E. Ann Gormley. “Depriving yourself of these activities may in turn lead to feelings of stress, shame and depression. It can also have a tremendous impact on self-esteem,” explains AUA member urologist and former AUA Foundation Research Scholar Dr. Tomas Griebling. Incontinence is also the primary reason that people move to assisted living, which can be costly and may limit the patient’s independence.
Continued on next page ø* www.UrologyHealth.org
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COVER STORY The two primary types of incontinence are stress urinary incontinence (SUI) and urge incontinence, commonly known as overactive bladder (OAB). SUI is leakage that occurs when there is an increase in abdominal pressure caused by physical activities like coughing, laughing, sneezing, lifting, straining, getting out of a chair or bending over. This pressure becomes greater than the sphincter and surrounding muscles holding the bladder neck together. The major risk factor for SUI is damage to the urinary sphincter and pelvic muscles, which may occur during pregnancy and childbirth. It may also occur due to loss of estrogen after menopause. When SUI occurs in men, it is usually due to a weakening of the pelvic floor and urinary sphincter musculature after prostate cancer surgery.
Mueller has had many frustrated patients come into her office and tell her that they have had treatment for one type of incontinence already without results. “The analogy that I often make for these patients is that it’s like you have two holes in your roof, and both are causing leakage. You should fix the bigger hole first, but you have to fix both holes to stop the leakage.”
Most treatment outcomes for urinary incontinence are highly successful for almost all patients.
Urge incontinence involves a sudden, strong urge to urinate quickly, and often an inability to get to the toilet in time. The bladder contracts or feels as though it is contracting involuntarily. Many patients with urge incontinence may leak urine with no warning. Risk factors for urge incontinence include aging, obstruction of urine flow when the bladder outlet is too tight (sometimes due to an enlarged prostate in men), inconsistent emptying of the bladder and a diet high in bladder irritants (such as coffee, tea, colas, chocolate and acidic fruit juices). Urge incontinence may also occur in conjunction with advanced diabetes or neurological conditions.
It is important for a urologist to get an accurate patient history in order to determine what type of incontinence the patient has and, if they have mixed incontinence, which type of incontinence is most severe. The urologist will ask questions about the pattern of symptoms and fluid intake. It may be helpful to keep a bladder diary—recording the frequency, timing, amount and circumstances surrounding leakage. The urologist will also perform a physical examination, and sometimes further evaluation is necessary, including cystoscopy (placing a small scope or camera inside the bladder) or urodynamic tests (measuring pressure while voiding).
Other types of incontinence include overflow incontinence, which occurs when the bladder does not empty properly and the amount of urine produced exceeds the capacity of the bladder; and functional incontinence, which is an inability to get to the toilet in time due to limited mobility.
Behavior modifications are typically part of the treatment plan for all types of incontinence. The patient should exercise regularly and maintain a healthy weight to promote strength of the pelvic floor region. Kegel or pelvic floor exercises are particularly help-
While one type of incontinence is typically predominant, mixed incontinence, a combination of stress and urge incontinence, is actually the most common. According to AUA member urologist, past president of the Society for Women in Urology and “It’s Time to Talk About SUI” panel member Dr. Elizabeth Mueller, it is important to remember that most incontinence sufferers have a component of both stress and urge symptoms. Dr.
My Bladder Diary Keeping a daily bladder diary will help you and your healthcare provider determine whether or not you experience Stress Urinary Incontinence (SUI). Date:
Time
Drinks What kind?
How much?
Trips to the bathroom
Accidental leaks
How many times?
How much?
How much urine?
Did you feel a strong What were you urge to go? doing at the time? Yes / No
6 - 7 a.m. 7 - 8 a.m. 8 - 9 a.m. 9 - 10 a.m. 10 - 11 a.m. 11 a.m. - noon noon - 1 p.m. 1 - 2 p.m. 2 - 3 p.m. 3 - 4 p.m. 4 - 5 p.m. 5 - 6 p.m. 6 - 7 p.m. 7 - 8 p.m. 8 - 9 p.m.
Sneezing, exercising, etc.
A bladder diary can be found on UrologyHealth.org
ful. If the patient is a smoker, quitting may decrease leakage that results from stress and urge incontinence by limiting bladder irritants that may cause urge incontinence, and leading to less coughing that may cause SUI. Patients may also be asked to limit fluid intake, although as shown in Ellen’s case, this can be dangerous and should only be done in consultation with a healthcare provider. Timed voiding (or urinating at scheduled times during the day) may prevent urge incontinence, and the urologist may have the patient gradually increase the time between intervals. It is important to remember that results from behavioral modifications may take some time to go into effect. If behavioral modifications are not sufficient, patients with urge incontinence may find medications that relax the wall of the bladder (preventing frequent contractions) helpful. Another option is electrical nerve stimulation, which effectively tells the bladder to “relax.” Botox® may be appropriate for patients with neurological conditions. In extreme cases, surgery to enlarge the bladder may be considered when the bladder is extremely small or generates high pressure, but this is a major surgery with potential complications and should only be considered after thorough consultation with a urologist. When behavioral modifications are insufficient for patients with SUI, there are some surgical options available. Urethral bulking involves injecting synthetic or biological materials into the layers of the urethra or bladder neck to help tighten the muscle valve. This option is less effective but has a shorter recovery time than other surgeries. The most common surgery to treat SUI is the “sling” surgery, which can be done in about 30 minutes. A small incision is made in the vagina, and the sling (made of either synthetic or biological material) is inserted under the urethra to provide support and prevent leakage. Less common is the bladder neck suspension (or retropubic suspension) surgery, where an incision is made on the lower abdomen, and the neck of the bladder is sewn to the back of the pubic bone.
9 - 10 p.m. 10 - 11 p.m.
Print and copy this sheet to record as many days as necessary.
© 2011 American Urological Association Foundation, Inc.
Most treatment outcomes for urinary incontinence are highly successful for almost all patients. According to Dr. Gormley, “the great Continued on next page ø*
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COVER STORY thing about treating these conditions is that we are able to make a tangible change in the quality of life for practically every patient. As a colleague of mine says, we measure successful outcomes in high-fives and hugs.” Yet many patients experiencing urinary incontinence are hesitant to bring it up with their doctors or seek treatment. Many feel embarrassed and may think that incontinence is an inevitable part of aging and are surprised to find that they are not alone and that treatment is readily available. The AUA Foundation
launched the “It’s Time to Talk About SUI” and “It’s Time to Talk About OAB” campaigns in its “Urology for Women” initiative to fight the stigma surrounding urinary incontinence and to let women with this condition know that they have options. When Peg, another of Dr. Kobashi’s patients, was diagnosed with incontinence, she started talking about it with the women in her exercise group. She found that many members of the group told her they had been experiencing the same symptoms but had been too embarrassed to come forward.
You too can join the conversation. Talk to others who may be suffering from incontinence and talk to your doctor if you are experiencing leakage. As Peg says, “people need to feel comfortable talking about it; they should feel OK going to see the doctor about incontinence the way they would with a broken arm. It’s an embarrassing thing to have, so you can allow yourself to be ashamed, and let it take you over. But I didn’t want to do that. I took control.” u *Name changed
Find what you’re looking for on
UrologyHealth.org!
Are you a patient, researcher or healthcare provider? UrologyHealth.org has free resources available to you! • Use our “Find-A-Urologist” tool to search for Board-certified AUA member urologists by location and specialty area. • Find expert-reviewed information on more than 140 urologic health conditions. • Learn about the latest urologic health research supported by the AUA Foundation and find information about clinical trials in your area. • Get answers to your questions about FDA alerts, new research and other timely issues in urologic health from our Patient Alerts feature. • Access online patient support groups, prescription assistance, caregiver planning guides and other resources. We are constantly working to update and increase the resources offered on UrologyHealth.org, and we welcome your feedback! Please send your thoughts and suggestions to AUAFoundation@AUAFoundation.org.
Answers to quiz on page 1.
1. Answer: B, the bladder stores urine. 2. Answer: False, while the incidence of incontinence increases with age, incontinence is a medical condition that can be treated at any age. 3. Answer: False, about 70,000 Americans are diagnosed with bladder cancer each year. www.UrologyHealth.org
4. Answer: True, if you smoke, quitting will help reduce your risk of bladder and other types of cancer. 5. Answer: C, UTIs can develop in the bladder or kidneys or both. 6. Answer: False, men are about three times more likely to be diagnosed with bladder cancer than women.
7. Answer: B, blood in the urine, known as hematuria, is the most common symptom of bladder cancer. 8. Answer: B, SUI can be caused by laughing, sneezing or other physical movements that put pressure on the bladder.
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ADVOCACY
National Association For Continence:
A Key Voice
Founded in 1982, the National Association for Continence (NAFC) was established to address the lack of resources for continencerelated issues. Ms. Nancy Muller, named Executive Director of NAFC in 2000, has made it her focus to grow the organization and carry out its mission to educate the public about the causes, treatment options and management alternatives for incontinence, voiding dysfunction and related pelvic floor disorders. Ms. Muller and her team advocate for the millions of patients who experience continence-related conditions by joining other organizations and agencies to increase the visibility and priority given to these issues. This year, NAFC celebrates 30 years of patient outreach, advocacy and education initiatives. The organization plans to expand awareness messages so patients understand that they do not have to suffer in silence from any continence condition and are encouraged to use resources to understand and cope, but more importantly, overcome. We were pleased to interview Ms. Muller and Ms. Allison Wilfong, Manager of Media Relations and Communications at NAFC.
What can urologists, allied health professionals and other healthcare professionals do to encourage their patients to discuss the issue of incontinence? NAFC: We at NAFC think it is important for physicians to start
the conversation with their patients about incontinence. We have heard doctors say that they wait for patients to talk to them about an issue; as such, patients identify what is most important to them. However, patients suffering with continence-related issues may be too embarrassed or uncomfortable to bring up the topic. Studies have shown that, on average, women wait 6.5 years from the first time they experience symptoms until they obtain a diagnosis of bladder control problems. Therefore, it is important for healthcare providers to not wait for their patients to start the conversation, but rather to ask if they are having any symptoms or complications. Once providers and patients start the conversation, they must have an open and honest discussion. Many patients, such as those who have undergone prostate surgery, have said that their healthcare provid-
ers downplayed the effects that continence could have on their daily lives, which can lead to disappointment and distrust. We encourage providers to be open with patients and prepare them for what life will be like should they become incontinent. If the issue is not addressed thoroughly, patients can feel isolated and may be reluctant to seek help because they do not want to feel like they are not “normal.�
Nancy Muller, Executive Director of NAFC
What is NAFC doing to make sure the millions of people suffering from continence issues are aware of the resources, treatments and options for them? NAFC: Urinary incontinence affects over 200 million people world-
wide, including millions in the United States. During the last 30 years, NAFC has produced numerous patient and physician educational materials, hosted conferences and conducted workshops for patients. Over the last decade, NAFC has been actively reaching out to the Hispanic population. Our goal with this targeted campaign is to make sure that Hispanics feel better connected to the healthcare system and are provided with resources to access care when they experience continence issues. Last year, NAFC held a public forum in California for Hispanic migrant farm workers. The doctors and nurses not only delivered their message in Spanish, but also participated in one-onone conversations with attendees about continence-related issues. We also have a Spanish language specialist on staff who is able to provide Spanish-speaking patients with necessary information and resources. In addition, we created an online community where patients can interact with other patients with similar continence conditions. Continued on next page ø*
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www.UrologyHealth.org
ADVOCACY
Unlike posting on larger social media sites, this forum allows patients to openly discuss more personal details of their continence issues.
What are NAFC’s goals for the future? NAFC: We are actively working on having healthcare providers use
our resources. While many providers prefer to verbally give information to their patients, those patients who receive a serious diagnosis, such as prostate cancer, often cannot focus on subsequent discussion about incontinence. Therefore, it is important to provide patients with information they can take with them to review on their own time. After patients have time to consider the information, they can have a more productive conversation with their providers.
Given our success within the Hispanic community, we hope to better engage African Americans in the future. Our goal is to reach out to them at the first sign of incontinence and teach them not to ignore those symptoms. Recently, we provided health information to African Americans via text messages, and hope to expand our efforts using this technology. We at NAFC hope that our organization and the AUA Foundation can find new opportunities to work together and continue to educate, advocate and inform the patients we serve. u
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RESEARCH
What are Clinical Trials? You may have heard that you are eligible to participate in a clinical trial, or you may be interested in finding a clinical trial that targets your condition. Clinical trials are essential to the development of new treatments for urological conditions, such as bladder cancer or incontinence. However, before participating in a clinical trial, it is important to understand exactly what it entails and what to expect. Trials are essentially research studies that are biomedical related, involve human subjects and follow a predefined protocol. After researchers test potential therapies in the laboratory, the experimental treatments with the most promising results are moved to the clinical trial phase. Most clinical trials test the safety and effectiveness of a new treatment, while other clinical trials investigate whether a treatment works in a specific population or within a certain set of disease characteristics. Typically, clinical trials include a demographically diverse participant population so that researchers can compare and apply the results to the general population. In every trial, however, the eligibility requirements are different and often defined by the study’s objective. Prior to each clinical trial, researchers develop eligibility criteria, such as age, sex, type and stage of disease, previous treatment history and other medical conditions to recruit participants. Despite the need for a large number of eligible participants, not everyone who applies to a clinical trial is accepted. Clinical trials in the United States must have government registered protocols, which are detailed plans that outline the objectives, describe the characteristics of the patients that may participate in the study and provide precise schedules for the various drugs, dosages, tests and procedures involved. Before participating, patients must understand and agree to the information set forth in the protocol.
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Clinical trials can take various forms. In some cases researchers prescribe a medication for patients to take at home. However, many trials require patients to attend specifically scheduled follow-up appointments. It is less common for patients to be hospitalized for the duration of the study. In most clinical trials, researchers randomly and secretly designate participants into a group to receive the potential treatment or a group to receive the placebo. A placebo is a substance or practice that has no therapeutic effect. Researchers compare the results from each group to determine the actual effectiveness of the new treatment, as opposed to improvement due to unrelated factors, such as changes in daily activity, food intake or psychological perception. When the trial is complete, researchers will carefully analyze the collected data to produce a conclusion on the safety and effectiveness of a treatment for a particular population. Sometimes trials directly result in new information that helps prevent, detect and treat a disease. However, what may be discovered to be ineffective can help guide researchers even further in the development of a new treatment. Whether new treatments are marketed and become the standard of care or researchers learn something about a disease that helps scientific advancement, the outcomes of clinical trials are critical in modern medicine. To learn more about clinical trials, visit UrologyHealth.org and click on the “Research” tab. u
Common Types of Clinical Trials • Treatment: These trials involve individuals who have been diagnosed with a specific condition, and test the effectiveness of new and standard treatments while often combining several different types of treatment. • Prevention: These trials test new medications, lifestyle changes or other approaches to decreasing the risk of developing a certain health condition, and are most often conducted in healthy individuals who are then tracked for signs or symptoms. • Screening: These trials often involve individuals with no symptoms of a specific condition and test new ways to detect the presence or onset of that condition. • Diagnostic: These trials usually include individuals with signs and symptoms of a condition and test new methods for accurately detecting the presence of that condition. • Quality-of-Life: These trials seek ways to improve the quality of life of patients suffering from a particular condition, often by reducing side effects brought on by the condition or its treatment.
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. • Phase I: Researchers test an experimental 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 II: The experimental study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. • Phase III: The experimental study 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 experimental drug or treatment to be used safely.
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FEATURES
Special Thanks to Our Corporate Partners in Urology This past year, dozens of corporate, foundation and association donors helped to make a significant difference in the lives of millions of Americans diagnosed with urologic diseases through their support of AUA Foundation’s research, education and outreach initiatives. We are grateful for their continued generosity and commitment to urology.
This list includes donors who contributed $100,000 or more to the AUA Foundation during calendar year 2011.
American Medical Systems, Inc.
Boston Scientific Corporation
AUA Mid-Atlantic Section
Chesapeake Urology Associates
National Institute of Diabetes and Digestive and Kidney Diseases
AUA New England Section
Cleveland Clinic Lerner College of Medicine
Pfizer Inc.
AUA New York Section
Conrad & Associates, LLC
Speedy Feet of Ohio
AUA North Central Section
Dayton Physicians, LLC Urology Division
Urology Associates of Green Bay, SC
AUA Northeastern Section
Endo Pharmaceuticals Inc.
AUA South Central Section
Ferring Pharmaceuticals, Inc.
Wake Forest Institute for Regenerative Medicine
AUA Southeastern Section
Kidney Cancer Association
AUA Western Section
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FEATURES
Our most heartfelt thanks to our 2011 supporters!
The work of the AUA Foundation in urologic research, education and patient outreach is made possible through the generous support of the following individuals and institutions. The AUA Foundation staff, patients and healthcare providers we serve thank you for your commitment to urology and your generosity in 2011.
Partners in Urologic Health Michael E. Albo, MD Robert R. Bahnson, MD Robert B. Bailey, Jr., MD David M. Barrett, MD James K. Bennett, MD Steven M. Berman, MD Clay N. Boyd, MD Victor M. Brugh, III, MD W. Cooper Buschemeyer, Jr., MD H. Ballantine Carter, MD Jeannette Chassaignac, MD Jose J. Contreras, MD Larry E. Cooper John F. Danella, MD, and Susan O’Connor-Danella Fredy E. Delacruz, MD Dr. and Mrs. William C. DeWolf
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Steven G. Docimo, MD James A. Eastham, MD James V. Eaton, MD Rev. Msgr. Frederic F. Elkin Mark F. Ellison, MD Lars M. Ellison, MD Bernard H. Feldman, MD, and Sheryl Feldman Peter S. Filderman, MD Robert C. Flanigan, MD Aaron Frankel John R. Franklin, MD Suzanne Frye, MD Nelcar M. Gadrinab, MD Alexander C. Gellman, MD Mr. and Mrs. Charles E. Greene Herman M. Greenwald, MD Gregory S. Grose, MD, and Jennifer L. Grose Jerold Grubman, MD Robert M. Hall, MD
Sammy A. Hamway, MD Timothy B. Hopkins, MD William T. Jones, MD Martin and Wendy Kaplan Sathish Kasina, PhD Floyd A. Katske, MD Geoffrey B. Kostiner Sandra G. Krakoff Yegappan Lakshmanan, MD James R. Lawrence Lori B. Lerner, MD Richard H. Lewis, MD, and Deanna B. Lewis John A. Libertino, MD Deborah J. Lightner, MD Larry I. Lipshultz, MD Charles W. Logan, MD Edward S. Loh, MD Greg O. Lund, MD William C. McCulloch and Ann K. McCulloch
Kevin R. McDonald, MD Charles A. McWilliams, MD Hamayun S. Mian, MD Richard G. Middleton, MD Jay B. Miller, MD Bradford L. Moss, MD Scott M. Neusetzer, MD Michael T. Nguyen, MD Stephen R. Nold, MD Michael Ostad, MD Alan W. Partin, MD Dix P. Poppas, MD Donald L. Preate, Jr., MD, FACS Glenn M. Preminger, MD Kapil Puri, MD Richard C. Rink, MD Jeffrey Sandhaus, MD Timothy and Mary Scanlan Anthony J. Schaeffer, MD Edward M. Schaeffer, MD Roger H. Schoenfeld, DO
www.UrologyHealth.org
FEATURES Ladd J. Scriber, MD William A. See, MD Allen D. Seftel, MD Alan W. Shindel, MD Dorothy C. Sumner Emil A. Tanagho, MD David W. Terhune, MD Raju Thomas, MD Brett A. Trockman, MD, and Sharon A. Trockman Andrew C. von Eschenbach, MD Ronald W. Wadle, DO Zhou Wang, PhD Alan J. Wein, MD James R. Wendelken, MD Jacqueline E. Williams, MD Roy Witherington, MD Stephen A. Worsham, MD Charles W. Yowell, MD
Partners in Urologic Health Alliance
James Jeffery Boyd, MD Toby Chai, MD, FACS Joseph N. Corriere, Jr., MD Daniel J. Culkin, MD George F. Daniels, Jr., MD, and Kathleen M. Daniels Robert A. Edelstein, MD Phillip D. Eldridge Michael R. Ellen, MD, and Brigitte Ellen Todd J. Garvin, MD Henry Goode Malcolm Graff and Florence S. Graff John N. Graham, MD, and Joan K. Graham Robert T. Grissom, MD Cornelia C. Haag-Molkenteller, MD, PhD Scott M. Jarvis Sidney P. Kadish Dr. and Mrs. Jeffrey E. Kaufman Thomas P. Lehman, MD Dr. and Mrs. John H. Lynch Leonard Maldonado, MD Robert C. Newman, MD Kevin Pranikoff, MD William W. Roberts, III, MD Lawrence S. Ross, MD Kenneth E. Ruby, MD, and Michele Ruby Kyoko Sakamoto, MD
Michael T. Sheppard, CPA, CAE Janet Skorepa Pramod C. Sogani, MD Jonathan Starkman, MD Alan J. Stein, MD Craig D. Turner, MD Datta G. Wagle, MD Howard N. Winfield, MD Mr. and Mrs. Gunter H. Zittel
George and JoAnne Pappas Sanjay Ramakumar, MD Timothy L. Ratliff, PhD Alan B. Retik, MD, and Lynn E. Retik Hossein Sadeghi-Nejad, MD Dr. and Mrs. Paul F. Schellhammer Harvey A. Schneier, MD, and Barrie M. Mandel William D. Steers, MD, and Amy J. Steers Gerald Sufrin, MD Frederick G. Thompson and Donna L. Thompson E. Darracott Vaughan, Jr., MD, and Anne Vaughan Dennis D. Venable, MD Robert S. Waldbaum, MD, and Ruth Waldbaum, MD John T. Wei, MD Beverly Williams Michael Wong Wen T. Yap
Diamond Club, Founder’s Society
Doug and Dale Anderson Dean G. Assimos, MD Gopal H. Badlani, MD John M. Barry, MD Mitchell C. Benson, MD Michael C. Carr, MD, PhD David M. Chamberlain and Karin M. Chamberlain Ralph V. Clayman, MD James and Nancy Dougherty George W. Drach, MD, and Peggy Duckett Stephen and Janet Dunn Steven Fischman Brendan M. Fox, MD, and Maureen Fox Marc Goldstein, MD E. Ann Gormley, MD David F. Green, MD Tomas L. Griebling, MD, MPH Blake D. Hamilton, MD George P. Hemstreet, III, MD Alice A. Henderson David M. Hoenig, MD Louis R. Kavoussi, MD Samuel Krane and Susan Krane Ali R. Kural, MD Sushil S. Lacy, MD Tom F. Lue, MD Joseph N. Macaluso, Jr., MD Rev. Edward R. McClurkin Richard A. Memo, MD Michael E. Moran, MD Dr. and Mrs. Stephen Y. Nakada
William P. Didusch Circle, Founder’s Society Anthony Atala, MD Carl A. Olsson, Jr., MD, and Mary D. Olsson Stephen A. Sacks, MD
Hugh H. Young Circle, Founder’s Society Richard K. Babayan, MD Diane G. Krane Jonathan and Gina Krane
This list includes donors who contributed $250 or more to the AUA Foundation during calendar year 2011. All gifts of $100 or more are also recognized on the AUA Foundation’s Web site. Please accept our apologies for any errors or omissions.
A Special Thanks to AUA Member Contributors! Your support of the AUA Foundation’s Urologic Research Programs means so much. We were overwhelmed by the outpouring of support in 2011, and invite you to go to UrologyHealth.org to see a full list of AUA Foundation donors of $100 or more from the past year. Thank you.
www.UrologyHealth.org
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1000 Corporate Boulevard Linthicum, MD 21090
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The AUA Foundation provides me with the resources I need to educate my patients. Kathleen C. Kobashi, MD Urologist
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