The National Institute of Diabetes & Digestive & Kidney Diseases

Urological Diseases Databases, Registries and Information

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The GenitoUrinary Development Molecular Anatomy Project (GUDMAP) is a consortium of laboratories working to provide the scientific and medical community with tools to facilitate research. The key components are:

• a molecular atlas of gene expression for the developing organs of the GenitoUrinary (GU) tract
• a high resolution molecular anatomy that highlights development of the GU system
• mouse strains to facilitate developmental and functional studies within the GU system
• tutorials describing GU organogenesis
• rapid access to primary data via the GUDMAP database

For more information, contact Dr. Elizabeth Wilder, KUH, Director, Developmental Biology of the Kidney and Urogenital Tract Program.

The National Gene Vector Laboratories (NGVL) are composed of an interactive group of academic production and pharm/tox laboratories whose primary goal is to provide eligible investigators with clinical grade vectors for phase I/II gene therapy clinical trials and to provide support for relevant pharmacology/toxicology studies leading up to clinical gene transfer protocols. If the application is approved, clinical grade material will be produced at no cost to the investigator.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

or http://www.urologic.niddk.nih.gov The kidney and urologic diseases clearinghouse provides comprehensive information about bladder and renal health and disease for the public: online, in booklets and fact sheets, by email, and over the phone.

For more information, contact Ms. Kathy Kranzfelder, OCPL, Director, NIDDK Information Clearinghouses.

Urologic diseases cover a wide range of conditions, symptoms, and problems that include such diverse diagnoses as cancer, pelvic pain, sexual dysfunction, urinary incontinence, kidney stones, and benign prostatic hyperplasia (BPH). To remedy this lack of information, NIDDK initiated the Urologic Disease in America (UDA) project. The UDA compendium delineates the changes in the epidemiology, health economic impact, and practice patterns for the diseases currently included within the scope of practice of the specialty of urology, analyzed retrospectively over a ten-year period. The UDA compendium consists of data tables annotated in chapters that amplify the data analyses. The objectives of the UDA project include secondary data analyses of the following topics: (1) changes in the overall health care burden for individual urologic diseases; (2) changes in physician practice patterns for each urologic disease; (3) changes in demographics of persons with urologic disease; (4) the impact of specific urologic diseases, especially diseases of the prostate, on the minority populations of the U.S.; (5) documentation of new and evolving therapies for urologic disease and their potential impact on treatment outcomes and health care costs. The resultant compendium can be found at the above web address. In addition to updating the original compendium, the second phase of the UDA is to focus less on descriptive analyses and more on analytical outcomes analyses, and it will also attempt to increase involvement of the urologic community in analytical activities.

For more information, contact Dr. Paul Eggers, KUH, Director, Kidney and Urology Epidemiology Programs or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

Urological Diseases Multicenter Clinical Research

This study by the Urinary Incontinence Treatment Network (UITN) will determine if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will make it possible to discontinue the drug and still maintain a reduced number of accidents. The most popular treatments for urge incontinence are drug therapy and behavior therapy, each with its own limitations. In this clinical study, the UITN aims to determine differences with the addition of behavioral treatment to drug therapy alone.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.

The Boston Area Community Health (BACH) Survey is an epidemiologic study being conducted in the Boston metropolitan area to examine the prevalence of symptoms for health problems such as interstitial cystitis, urinary incontinence, benign prostatic hyperplasia, prostatitis, hypogonadism, and sexual function. Of interest to the survey are health disparities and inequalities. BACH is especially concerned with lack of adequate health insurance, lack of access to adequate medical care, and how these problems influence patterns of disease. The study also focuses on social determinants of disease that are over and above the contribution of individual characteristics and risk factors. To achieve a randomly sampled population, four neighborhoods were divided into 12 strata and from them investigators selected census blocks. Households were then randomly selected from the census blocks and sampled to identify eligible study participants.

For more information, contact Dr. Paul Eggers, KUH, Director, Kidney and Urology Epidemiology Programs or Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

The Complementary and Alternative Medicine for Urological Symptoms (CAMUS) is a randomized, placebo controlled trial of phytotherapy for benign prostate symptoms among men.

For more information, contact Dr. Leroy Nyberg, KUH, Director, Urology Programs.

This trial will test an FDA-approved antidepressant for its potential to alleviate bladder pain for which there is no known cause and no effective therapy. Ten medical centers in the United States and Canada are recruiting adults newly diagnosed with either painful bladder syndrome (PBS) or interstitial cystitis (IC) to learn if the oral drug amitriptyline (Elavil®) will reduce the pain and frequent urination that are hallmarks of the conditions.

For more information, contact Dr. Leroy Nyberg, KUH, Director, Urology Programs.

The Interstitial Cystitis Clinical Trials Group, established by the NIDDK, has conducted clinical trials research into novel treatments for IC and studied potential biomarkers for the disease in urine. Recently, this group has been expanded to form the Interstitial Cystitis Clinical Network (ICCRN) to further assess potential new treatments for IC and foster basic research of IC and bladder disorders.

For more information, contact Dr. Paul Eggers, KUH, Director, Kidney and Urology Epidemiology Programs.

The MaGIC study will investigate several hundred families with two or more blood relatives with interstitial cystitis in order to understand the molecular genetic basis of this condition.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

Serum and biopsy samples from the MTOPS clinical trial represent a valuable resource for those seeking to develop and evaluate biological and genetic markers useful in the detection of BPH, or in predicting progression and response to therapy.

For more information, contact Dr. Chris Mullins, KUH, Director, Urology Basic Cell Biology Program.

PRIDE (Program to Reduce Incontinence by Diet and Exercise) is an exciting new research study to learn more about the effects of weight loss on urinary incontinence. About 330 overweight women aged 30 or older will participate in this randomized controlled trial. PRIDE is being conducted at two clinical centers in the United States and is coordinated by the Women's Health Clinical Research Center at the University of California, San Francisco.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

The multicenter, randomized, double-blind, placebo-controlled RIVUR trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of UTI in children with VUR. The basic eligibility criteria are: (1) age at randomization of at least 2 months, but less than 6 years, (2) a diagnosed first febrile or symptomatic UTI within 42 days prior to randomization that was appropriately treated, and (3) presence of Grade I-IV VUR based on voiding cystourethrogram (VCUG). Patients will be randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study is designed to recruit 600 children (approximately 300 in each treatment group) over an 18-24 month period. The primary endpoint is recurrence of UTI. In addition, patients will be evaluated for secondary endpoints related to renal scarring and antimicrobial resistance. Scarring will be determined based on renal scintigraphy by 99mTc dimercaptosuccinic (DMSA) scan. Quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.

For more information, contact Dr. Marva Moxey-Mims, KUH, Director, Kidney Centers Program; Pediatric Nephrology Program; Applied Kidney SBIR/STTR Program or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

The primary aim of this clinical trial under the UITN is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.

The overarching purpose of this proposal (Grant 5U01DK066134-03) is to address a set of critical questions about the etiology of interstitial cystitis (IC) using multivariate data from a large population-based classical twin study. Despite ongoing research, IC remains a controversial entity for two critical reasons. First, the validity of the case definition remains uncertain. There are few data that address a historically important validator--the degree to which IC results from genetic and/or environmental factors. Second, IC is often comorbid with one or more additional physical disorders and yet the causes of comorbidity are uncertain. Taken together, these two sets of unanswered questions contribute significantly to the controversies that continue to surround IC. Moreover, the strong female predominance of IC has been amply documented but is not well understood. To address these fundamental issues, it is proposed to conduct a twin study of IC in the population-based Swedish Twin Registry (STR). This study is part of the Interstitial Cystitis Genetics Consortium. The other part is the Maryland Genetics of Interstitial Cystitis (MaGIC)    study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

In this clinical trial, the Urinary Incontinence Treatment Network (UITN) aims to compare two surgical approaches of minimally invasive procedures for the treatment of stress urinary incontinence.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.

or http://www.uitn.net/    

The network is a group of collaborating investigators who conduct long-term studies and clinical trials of the most commonly used surgical, pharmacological, and behavioral approaches for management of urinary incontinence in women diagnosed with stress and mixed incontinence.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.

The UPPCRN is the overarching organization for collaborative research in chronic prostatitis, chronic pelvic pain syndrome, and interstitial cystitis. It serves as the official NIDDK Working Group on chronic pelvic pain of urological origin, to facilitate interaction of study groups and investigators, both nationally and internationally, to advance our understanding, diagnosis, and treatment of these diseases.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.

Urological Diseases Basic Research Networks

The AMDCC is an interdisciplinary consortium designed to develop animal models that closely mimic the human complications of diabetes for the purpose of studying disease pathogenesis, prevention and treatment. The consortium consists of thirteen “pathobiology sites” that study complications such as diabetic nephropathy, uropathy, neuropathy, cardiomyopathy and vascular disease. Additional goals of the AMDCC are to define standards to validate each diabetic complication for its similarity to the human disease, test the role of candidate genes that emerge from human genetic studies, and facilitate the exchange of animals, reagents, and expertise between members of the consortium and the greater scientific community. To ensure that all mice generated under the auspices of the AMDCC are phenotyped for a full duration of diabetes and across all relevant complications, the consortium has formed a close partnership with the NIDDK-funded Mouse Metabolic Phenotyping Centers (MMPCs). The MMPCs (www.mmpc.org) conduct detailed metabolic phenotyping of genetically altered mice and other mouse models that are useful for understanding diabetes and its complications, obesity, and related metabolic diseases or conditions.

For more information, contact Dr. Chris Ketchum, KUH, Director, Basic Renal Biology Program.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

Serum and biopsy samples from the MTOPS clinical trial represent a valuable resource for those seeking to develop and evaluate biological and genetic markers useful in the detection of BPH, or in predicting progression and response to therapy.

For more information, contact Dr. Chris Mullins, KUH, Director, Urology Basic Cell Biology Program.

NMRI is a communication network of current and potential biomedical research investigators and technical personnel from traditionally under-served communities: African American, Hispanic American, American Indian, Alaskan Native, Native Hawaiian, and other Pacific Islanders. The major objective of the network is to encourage and facilitate participation of members of underrepresented racial and ethnic minority groups in the conduct of biomedical research in the fields of diabetes, endocrinology, metabolism, digestive diseases, nutrition, kidney, urologic and hematologic diseases. A second objective is to encourage and enhance the potential of the underrepresented minority investigators in choosing a biomedical research career in these fields. An important component of this network is promotion of two-way communications between network members and the NIDDK.

For more information, contact Ms. Winnie Martinez, Program Analyst, Office of Minority Health Research Coordination.

Urological Diseases Reagents

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The National Gene Vector Laboratories (NGVL) are composed of an interactive group of academic production and pharm/tox laboratories whose primary goal is to provide eligible investigators with clinical grade vectors for phase I/II gene therapy clinical trials and to provide support for relevant pharmacology/toxicology studies leading up to clinical gene transfer protocols. If the application is approved, clinical grade material will be produced at no cost to the investigator.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

Urological Diseases Services

A centralized facility established to provide genotyping and statistical genetics services for investigators seeking to identify genes that contribute to human disease. CIDR concentrates primarily on multifactorial hereditary disease although linage analysis of single gene disorders can also be accommodated.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

NIH RAID provides a variety of contract services researchers need to bring promising potential therapeutics to trial.

Urological Diseases Standardization Programs

Urological Diseases Tissues, Cells, Animals

The AMDCC is an interdisciplinary consortium designed to develop animal models that closely mimic the human complications of diabetes for the purpose of studying disease pathogenesis, prevention and treatment. The consortium consists of thirteen “pathobiology sites” that study complications such as diabetic nephropathy, uropathy, neuropathy, cardiomyopathy and vascular disease. Additional goals of the AMDCC are to define standards to validate each diabetic complication for its similarity to the human disease, test the role of candidate genes that emerge from human genetic studies, and facilitate the exchange of animals, reagents, and expertise between members of the consortium and the greater scientific community. To ensure that all mice generated under the auspices of the AMDCC are phenotyped for a full duration of diabetes and across all relevant complications, the consortium has formed a close partnership with the NIDDK-funded Mouse Metabolic Phenotyping Centers (MMPCs). The MMPCs (www.mmpc.org) conduct detailed metabolic phenotyping of genetically altered mice and other mouse models that are useful for understanding diabetes and its complications, obesity, and related metabolic diseases or conditions.

For more information, contact Dr. Chris Ketchum, KUH, Director, Basic Renal Biology Program.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

Serum and biopsy samples from the MTOPS clinical trial represent a valuable resource for those seeking to develop and evaluate biological and genetic markers useful in the detection of BPH, or in predicting progression and response to therapy.

For more information, contact Dr. Chris Mullins, KUH, Director, Urology Basic Cell Biology Program.

The goal of the MMRRC program is to enhance the availability of and help ensure the quality of genetically modified mice for biomedical research of human and animal biology and disease.

For more information, contact Dr. Kristin Abraham, DEM, Director, Cell Signaling and Diabetes Centers Program.

NIDDK has funded a Type 1 Diabetes Resource (T1DR) at The Jackson Laboratory (TJL). The purpose of this resource is to collect and cryopreserve ~150 mouse stocks important to research in type 1 diabetes.

For more information, contact Dr. Kristin Abraham, DEM, Director, Cell Signaling and Diabetes Centers Program.

Urological Diseases Useful Tools

A questionnaire developed in 1999 by physicians in NIDDK's Chronic Prostatitis Collaborative Research Network can help physicians to accurately measure the severity of prostatitis symptoms and their impact on a patient's lifestyle. The CPSI questionnaire assesses pain, urination, and the effect of chronic prostatitis on daily activities. With this information, researchers and physicians can reliably evaluate whether potential treatments are working. The questionnaire was originally published in the Journal of Urology in August 1999 (Vol. 162, pages 369-375). It is available as a PDF document in English, Spanish, German and Korean.

Adapted from the American Urology Association's Symptom Score for BPH, this chart will assist physicians, researchers, and patients in assessing the severity of the problem.