Grant Number: 1U01DK065297-01
PI Name: ANDERSON, RODNEY U.
PI Email: [email protected]
PI Title:
Project Title: Chronic Prostatitis Collaborative Research Network
Abstract: DESCRIPTION (provided by applicant): This application proposes that Stanford University School of Medicine, Department of Urology, participate as one of several National Clinical Centers in a cooperative effort to develop feasible clinical trials for the study of chronic prostatitis/chronic pelvic pain syndrome. The Principal Investigator intends to participate fully as a member of the steering committee in designing randomized controlled clinical trials and facilitate carrying them out in collaboration with other national center Pl's. The investigative group at Stanford will work in parallel with the centers conducting trials for investigation of interstitial cystitis. A simultaneous application for that effort is being submitted. While the precise pathophysiology and biologic basis of chronic pelvic pain, particularly associated with genitourinary dysfunction, have not been elucidated, a large number of men in the United States continue to suffer immeasurably for many years with this chronic disorder. Multimodal therapy exists as the only management approach and, for the most part, lacks sound scientific justification. The specific aim of this project is to utilize clinical experience from the most experienced and knowledgeable physicians available to design clinical trials of treatment modalities that may provide a favorable therapeutic response among the many sub-groups of this population of patients. Investigation within these trials will stretch from pharmaceutical to complimentary holistic treatment methods, representing the best of ideas chosen by the participating centers. The Stanford Group intends to contribute experience and expertise with regard to managing chronic prostatitis/chronic pelvic pain syndrome utilizing a neurobehavioral therapy and proposes a clinical trial of targeted physiotherapeutic myofascial release of painful trigger points with progressive relaxation exercises. The psychophysiological vagaries among patients suffering from this disorder have long been appreciated, but poorly defined, and deserve a fresh look with a dedicated "hands on" clinical effort conducted by several investigators simultaneously and with rigorous clinical research design.
Thesaurus Terms:
chronic pain, human therapy evaluation, pelvis, prostatitis
clinical trial, cooperative study, method development, patient oriented research, physical therapy
clinical research, electromyography, human subject, male, questionnaire
Institution: STANFORD UNIVERSITY
STANFORD, CA 94305
Fiscal Year: 2003
Department: UROLOGY
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1R01DK062861-01
PI Name: THEOHARIDES, THEOHARIS C.
PI Email: [email protected]
PI Title: PROFESSOR
Project Title: Restraint stress-induced neurogenic bladder inflammation
Abstract: DESCRIPTION (provided by applicant): The urinary bladder is often the site of subacute or chronic inflammation, in the absence of infection, as in interstitial cystitis (IC), a painful bladder disorder occurring mostly in women. Symptoms of urinary frequency and pelvic pain commonly worsen perimenstrually and under stress in IC. Bladder mastocytosis with mast cell activation has been documented in IC. We also showed that acute immobilizationstress in rodents induced bladder mast cell activation, a process that was dependent on the neuropeptides neurotensin (NT) and substance P (SP), as it was absent in rodents treated with capsaicin to deplete sensory nerve fibers of their SP content and was also inhibited by the NT receptor antagonist SR48692. Moreover, pretreatment of bladder with estradiol increased the stimulatory effect of SP, by activating high affinity estrogen receptors that we have identified on bladder mast cells. It was recently shown that bladder inflammation could not occur in mast cell deficient mice infected with the neurotropic pseudorabies virus. Mast cells are located perivascularly close to nerve processes and may secrete many vasoactive, proinflammatory and neurosensitizing molecules in response to allergic triggers, as well as by direct nerve stimulation and by acute immobilization stress. Corticotropin releasing hormone (CRH) is released from the hypothalamus under stress and activates the hypothalamic-pituitary-adrenal (HPA) axis. However, both CRH and its structurally related urocortin (Ucn) are also released in the periphery where they have proinflammatory effects. CRH and Ucn induced rat skin mast cell activation and increased vascular permeability, both of which were inhibited by pretreatment with neutralizing antiserum to CRH or the CRH-receptor (CRH-R) antagonist, antalarmin. CRH or acute stress-induced skin vascular permeability was absent in W/W v mast cell deficient mice, but was present in their +/+ controls indicating it is mast cell dependent. Acute stress also triggered rat bladder mast cell activation that was blocked by a NT-receptor antagonist. The proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosisfactor-alpha (TNF-alpha) were recently shown to be elevated in urine of IC patients. We are hypothesizing that acute stress releases (CRH) and/or (Ucn) in the bladder leading, directly or through SP or NT, to mast cell activation, increased vascular permeability and the expression of proinflammatory molecules. We propose to use normal and genetically deficient female mice to investigate the effect of acute stress and CRH/Ucn on: (1) bladder mast cell and urothelial Nuclear Factor kappa B (NF-kappaB)activation, as well as the levels of histamine,lL-6 and TNF-alpha in the urine collected from an indwelling catheter; (2) bladder vascular permeability quantitated by 99Technetium-gluceptate (99Tc) extravasation; (3) Vascular permeability, urine mediator release, as well as NF-kappaB activation in W/W v mast cell deficient mice, as well as in CRH knock-out mice and their +/+ controls; (4) mouse bladder mast cell and urothelial NF-KB activation, as well as secretion of histamine, IL-6 or TNF-alpha induced by intravesical administration of CRH/Ucn. These studies will help us understand how acute stress triggers bladder mast cell activation leading to increased vascular permeability and proinflammatory molecule release. Our findings may be relevant to the pathophysiology of IC and may suggest new therapeutic approaches.
Thesaurus Terms:
corticotropin releasing factor, hormone regulation /control mechanism, inflammation, mast cell, neurogenic urinary bladder disorder, stress
histamine, interleukin 6, neurotensin, nuclear factor kappa beta, substance P, tumor necrosis factor alpha, vascular endothelium permeability
autoradiography, female, gel mobility shift assay, laboratory mouse, light microscopy, transgenic animal
Institution: TUFTS UNIVERSITY BOSTON
BOSTON, MA 02111
Fiscal Year: 2003
Department: PHARMACOL & EXPER THERAPEUTICS
Project Start: 01-JUN-2003
Project End: 30-APR-2007
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: BBBP
Grant Number: 1U01DK065186-01
PI Name: PONTARI, MICHEL A.
PI Email: [email protected]
PI Title: ASSOCIATE PROFESSOR
Project Title: Chronic Prostatitis Collaborative Research Network
Abstract: DESCRIPTION (provided by applicant): This study is designed to form an interactive research network of clinical centers to develop and conduct randomized clinical trials to evaluate novel therapies in patients with category III prostatitis. The research group will conduct ancillary studies to investigate the etiology and pathogenesis of chronic prostatitis, and also participate with researchers performing similar studies in patients with Interstitial Cystitis (IC) in an organization which will investigate both entities. This is a proposal to be chosen as one of the clinical centers which will be carrying out these studies. Temple University is particularly qualified to do so for a number of reasons. We have extensive experience with both Chronic Prostatitis and Interstitial Cystitis, and were one of the participating centers in the Chronic Prostatitis Collaborative Research Network (CPCRN). We have been very successful in past clinical trials recruiting and retaining men for studies of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The investigators have expertise in both clinical and basic science investigation in chronic pelvic pain. We are located in an urban area and have access to a large minority population. To fulfill the aims of this study we propose a randomized placebo controlled trial of an antidepressant medication which has shown efficacy in chronic neuropathic pain conditions. We have detailed our experience with successfully recruiting and retaining men for trials of chronic prostatitis, as well as our experience with pitfalls in trial design. Plans for subgroups analyses are provided. We will also participate in the Urologic Chronic Pelvic Pain Syndromes Collaborative Group. We provide evidence of our ongoing interest and studies in the comparison and characterization of both CP/CPPS and IC. Issues in developing a clinically relevant definition of urologic chronic pelvic pain syndromes are discussed.
Thesaurus Terms:
clinical research, clinical trial, experimental design, human therapy evaluation, prostatitis, reproductive system disorder chemotherapy
antidepressant, chronic pain, cooperative study, disease /disorder classification, disease /disorder etiology, interdisciplinary collaboration, interstitial cystitis, neuropathology, pelvis, quality of life, reproductive system pharmacology
human subject, male, patient oriented research, sample collection, urinalysis
Institution: TEMPLE UNIVERSITY
406 USB, 083-45
PHILADELPHIA, PA 19122
Fiscal Year: 2003
Department: UROLOGY
Project Start: 01-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065189-01
PI Name: SHOSKES, DANIEL A.
PI Email: [email protected]
PI Title: PROFESSOR
Project Title: Clinical Trial Development in Chronic Pelvic Pain Syndr*
Abstract: DESCRIPTION (provided by applicant): Chronic Pelvic Pain Syndrome (CPPS) is a prevalent multifactorial disorder with variable and often disappointing response to therapy. There is evidence for infection, inflammation and neuromuscular spasm as the underlying cause in different patients despite identical clinical presentation. Large multicenter clinical trials are required to help delineate effective therapies and to identify which patients have the highest chance of success for a particular intervention. The Chronic Prostatitis Clinic at the Cleveland Clinic Florida has a high volume of patients, both newly diagnosed and longstanding. We have done numerous clinical trials in chronic prostatitis with rapid enrolment, 100% accrual of set targets and high rates of retention. We have a team of clinical specialists in allied fields important to the understanding of this condition, including experts in erectile dysfunction, rectal dysfunction, chronic pain management, complementary therapies (acupuncture, phytotherapy) and neuropsychology. We also maintain a basic science laboratory which would be equipped to perform any necessary molecular or biochemical ancillary studies such as real time PCR, oxidative stress markers, cytokines and genetic polymorphisms. Through our participation in the CPCRN and first NIH chronic prostatitis randomized clinical trial, we have demonstrated the ability to work collaboratively and to participate in study design and execution. As an example of a potential clinical trial, a study of water induced thermotherapy is outlined.
Thesaurus Terms:
chronic pain, clinical trial, experimental design, human therapy evaluation, hyperthermia therapy, prostatitis
Hispanic American, hypertrophy, interdisciplinary collaboration, quality of life
clinical research, cystoscopy, human subject, male, patient oriented research, urinalysis, urinary catheterization
Institution: CLEVELAND CLINIC FOUNDATION
9500 EUCLID AVE
CLEVELAND, OH 44195
Fiscal Year: 2003
Department:
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065174-01
PI Name: NICKEL, J CURTIS.
PI Email: [email protected]
PI Title:
Project Title: Chronic Prostatitis Collaborative Research Network CPCRN
Abstract: DESCRIPTION (provided by applicant): The RFA specifically requests that the applicants confirm their interest and ability to take part in clinical treatment trials in chronic pelvic pain syndrome (CPPS) in men. The Queen's University Prostatitis Research Group was established under the directorship of Dr. J. Curtis Nickel in Kingston, Canada approximately 10 years ago. In the last 8 years, Dr. J.C. Nickel has been the principal investigator (or in 2 cases principal co-investigator) of 16 clinical trials enrolling 935 patients designed to evaluate 13 treatment modalities. The Queen's University site has enrolled 357 patients, specifically in clinical treatment trials (this does not include the hundreds of patients recruited for etiology and diagnostic studies during the same time period). As part of the first NIH CPCRN, the Queen's University site exceeded its enrollment quota for all studies including RCT#1. The prostatitis research group is closely affiliated with the Queen's University Interstitial Cystitis Research Group (PI Dr. J.C. Nickel) which is collaborating in the NIH ICCTG RCT#1. The IC research center is also meeting its recruitment quota in RCT#1. This application describes our aim to participate in the proposed NIH CPCRN as well as the proposed urological chronic pelvic pain syndromes collaborative group (UCPPSCG). Our group is proposing a clinically relevant definition of the urologic chronic pelvic pain syndromes encompassing both male CPPS and IC. This definition, based on chronic genito-urinary pain/discomfort with subcategories for urinary frequency/urgency and no urinary frequency/urgency will, if adopted by the UCPPSCG, facilitate decisions on treatments to be evaluated and increase the accrual rate of study participants in both CPPS and IC. We develop a rationale, hypothesis, objectives necessary to propose a 16 week randomized placebo controlled clinical trial (employing 2X2 factorial design) to evaluate the efficacy and safety of amitriptyline and gabapentin for the amelioration of symptoms in men with a clinical diagnosis of CPPS. The Queen's University site with Dr. Nickel as PI has the experience, expertise and the proven ability to design, implement and enroll patients with CPPS in clinical studies and will be a valuable partner in the proposed CPCRN and UCPPSCG.
Thesaurus Terms:
There are no thesaurus terms on file for this project.
Institution: QUEEN'S UNIVERSITY AT KINGSTON
KINGSTON K7L 3N6, CANADA
KINGSTON,
Fiscal Year: 2003
Department:
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 5U01DK053746-05
PI Name: NICKEL, J CURTIS.
PI Email: [email protected]
PI Title:
Project Title: CHARACTERIZATION & TREATMENT OF CATEGORY III PROSTATITIS
Abstract: DESCRIPTION (Taken from the applicant's Abstract) Characterization and Treatment of Category III Prostatitis Background: Chronic abacterial prostatitis and prostatodynia (NIH Category III), remains a frustrating enigma for North American physicians and patients. Our definition of the syndrome is unclear, the etiology is obscure, the relevance of the only objective finding we have (leukocytosis) is unknown, symptoms are highly variable, the natural history of the disease has not been adequately studied and the clinical treatment trials are poorly designed, small and inconclusive. Objectives: To collaboratively develop validated NIH assessment instruments for the study of Category III prostatitis, analyze objective microscopic, microbiological, immunological and molecular biological parameters and develop a long term collaborative multicenter study in which a number of potential standardized treatment protocols could be tested. Research Design: Part 1: Retest, revalidate and revise as necessary the Principal Investigator's published prostatitis specific Symptom Frequency Questionnaire (SFQ) and Symptom Severity Index (SSI) in 100 prostatitis patients presently being studied and 100 age matched control patients. These modified indices would be subsequently used as the basis for a consensus and evidence based NIH prostatitis specific symptom assessment instrument to be tested prospectively in 200 prostatitis and 100 control patients. Part 2: Analyze objective microscopic, microbiological, immunological and molecular biological aspects of expressed prostatic secretions, semen and urine specimen after prostatic massage in these 300 patients. of potential standardized treatment protocols (conservative, antibiotic, alpha blockade and repetitive prostatic massage; alone or in combination) will be tested in patients enrolled in part 1 and part 2. Results from this 3 part study will be analyzed and correlated between groups and within groups, both concurrently and sequentially.
Thesaurus Terms:
epidemiology, human therapy evaluation, longitudinal human study, prostatitis, quality of life, reproductive system disorder chemotherapy, sign /symptom
alpha antiadrenergic agent, analgesia, antibacterial agent, clinical trial, diet therapy, sex behavior
clinical research, enzyme linked immunosorbent assay, human subject, immunology, microbiology, microscopy, molecular biology, polymerase chain reaction, questionnaire, semen, tissue /cell culture, urinalysis
Institution: QUEEN'S UNIVERSITY AT KINGSTON
KINGSTON K7L 3N6, CANADA
KINGSTON,
Fiscal Year: 2002
Department:
Project Start: 27-MAR-1998
Project End: 31-AUG-2004
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065287-01
PI Name: BERGER, RICHARD E.
PI Email: [email protected]
PI Title: ASSOCIATE PROFESSOR
Project Title: Becoming a member of the CPCRN-for prostatitis
Abstract: DESCRIPTION (provided by applicant): The long-term goals of the proposal are to establish a clinical center for the study and treatment of chronic pelvic pain in both genders and to co-operate with and contribute to other investigators in establishing and conducting multicenter clinical trials. In specific, this proposal is concerned with men with chronic male pelvic pain syndrome and with becoming a clinical site for the CPCRN. Our specific aims are to: (1) assist the CPCRN to establish study designs for clinical trials, develop forms, develop clinical definitions, recruit subjects for CPCRN trials, and to analyze and publish data in a co-operative and interactive manner; (2) support and take part in the Urological Chronic Pelvic Pain Syndromes Collaborative Group in a co-operative and interactive manner; (3) develop and conduct ancillary studies, which will provide further understanding of chronic prostatitis. Subjects will be recruited from the practice of Dr. Berger at the University of Washington Medical Center (UWMC) and the outpatient clinics at Group Health Cooperative of Puget Sound (GHC) and the University of Washington Physicians Network (UWPN). Dr. Berger sees approximately 200 new patients with CPPS per year, and GHC sees approximately 250 patients per year with newly diagnosed CPPS. By combining the patient population of both Seattle Medical Centers, we will be able to recruit a mix of previously treated and newly diagnosed patients into CPCRN clinical protocols. The Principal Investigator has a multidisciplinary team, currently performing clinical and laboratory studies in CPPS in men. Over the past four years, the Principal Investigator has enrolled 590 subjects into IRB approved studies of CPPS that have used a variety of methodological perspectives and examined a variety of etiological factors. We believe that we are ideally suited to contribute to the design and implementation of future studies performed by the CPCRN. Furthermore, the same multidisciplinary focus and experience will allow us the flexibility to design and carry out ancillary studies, which will fit with the overall plan of the CPCRN.
Thesaurus Terms:
There are no thesaurus terms on file for this project.
Institution: UNIVERSITY OF WASHINGTON
SEATTLE, WA 98195
Fiscal Year: 2003
Department: UROLOGY
Project Start: 26-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065257-01
PI Name: LITWIN, MARK S.
PI Email: [email protected]
PI Title: ASSOCIATE PROFESSOR
Project Title: Chronic Prostatitis Collaborative Research Network
Abstract: DESCRIPTION (provided by applicant): The goal of this application is to establish a clinical trial center at UCLA, Harbor UCLA Medical Center, and Martin Luther King-Drew Medical Center that will participate in collaborative, multi-site clinical trials sponsored by a newly established NIDDK-sponsored Chronic Prostatitis Collaborative Research Network (CPCRN). As a CPCRN site, UCLA will (1) participate in the design of randomized controlled clinical trials to treat the symptoms associated with chronic prostatitis, also known as chronic pelvic pain syndrome (CPPS) (2) develop and conduct ancillary studies, which will provide further understanding of CPPS (3) determine if there is a different response to therapy between sub-groups of patients, including newly diagnosed and chronic, long-term patients with CPPS (4) recruit sufficient numbers of patients with CCPS, including an adequate number of newly diagnosed cases, into these clinical trials (5) jointly work with other CPCRN investigators, including a Data Coordinating Center, to analyze and interpret the results of the trials (6) participate in a newly established Urological Chronic Pelvic Pain Syndromes Collaborative Group to facilitate the efficient conduct of clinical trials in both interstitial cystitis and chronic prostatitis The study will develop a clinically relevant definition of the urologic chronic pelvic pain syndromes, based on the clinical findings from these and other related clinical studies. The UCLA site has demonstrated experience in recruiting minority subjects to participate in research studies, including clinical trials, for CPPS and other urologic conditions. The UCLA site will build upon its experience as a charter site in the first CPCRN to achieve the goals set out by the second.
Thesaurus Terms:
There are no thesaurus terms on file for this project.
Institution: UNIVERSITY OF CALIFORNIA LOS ANGELES
10920 Wilshire Blvd., Suite 1200
LOS ANGELES, CA 90024
Fiscal Year: 2003
Department: UROLOGY
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1R01DK065990-01
PI Name: DIMITRAKOV, JORDAN D.
PI Email: [email protected]
PI Title:
Project Title: Diagnostic Challenges in IC (and Male CPPS)
Abstract: DESCRIPTION (provided by applicant): The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of complex but inter-related genetic and acquired diseases resulting from the interaction of several genes regulating immune/inflammatory and neurogenic parameters and environmental factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency and sexual specific symptoms. New research has delineated the dynamic and powerful association of the immune and neurogenic system in pain activation. An immune-modulated neurogenic model of IC illuminating the action of immune derived substances and pain related substances might be important in discovering the determinants of pain, voiding dysfunction and gender specific sexual problems. This inter-related dynamic model of IC disease pathogenesis could be explored for potential avenues leading to novel diagnostic and treatment strategies. We plan to identify and evaluate the sensitivity and specificity of several novel nerve and inflammation related markers in the diagnosis and follow up of IC (and CP/CPPS). By correlating the levels of urine immune and pain related substances to disease mechanisms, severity and progression, we may be able to create a human disease specific model for diagnosis and treatment.
Thesaurus Terms:
There are no thesaurus terms on file for this project.
Institution: QUEEN'S UNIVERSITY AT KINGSTON
KINGSTON K7L 3N6, CANADA
KINGSTON,
Fiscal Year: 2003
Department:
Project Start: 20-SEP-2003
Project End: 31-AUG-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZRG1
Grant Number: 5R01DK038955-15
PI Name: KRIEGER, JOHN N.
PI Email: [email protected]
PI Title: PROFESSOR OF UROLOGY
Project Title: Urological Studies of Ideopathic Lower Tract Syndrome
Abstract: DESCRIPTION (provided by applicant): Prostatitis syndromes cause major morbidity with a 10 percent prevalence among adult men. This project focuses on the most common category, chromc prostatitis/chronic pelvic pain syndrome (CP/CPPS). Long-term objectives are to determine the causes, consequences, and optimal therapy. Our working model is that bacterial infection is critical in many patients. Specific Aim #1. 16S rDNA evaluation, cloning, sequencing and phylogenitic studies. We will test the hypothesis that CP/CPPS patients have prostatic bacteria that distinguish them from controls. In pilot studies, patients with expressed prostatic secretion (EPS) inflammation (WBCs) were more likely to have bacterial rthosomal-encoding DNAs (16S rDNAs) than those without WBCs. We will clone and sequence 16S rDNAs from patients and controls. Sequences will be compared to available databases using BLAST searches and phylogeny software. These data will allow us to determine which bacteria are most specific to CP/CPPS, and, thus, which should be targeted in clinical trials. Specific Aim #2. Bacterial viability and clinical characteristics of CP/CPPS patients. We will test the hypothesis that bacterial viability correlates with the clinical severity of CP/CPPS. In pilot studies to evaluate bacterial viability, we developed quantitative assays for bacterial elongation messenger RNAs (tuf mRNAs) and documented that some CP/CPPS patients were tuf mRNApositive. We will compare clinical characteristics of patients with 16S rDNA and tuf mRNA, patients with 1 6S rDNAs but no tuf mRNA, and those without 1 6s rDNA or tuf mRNA. The tuf mRNA studies will be correlated with improved cultutes of the same specimens. This study will provide insights into the potential value of antimicrobial therapy and identify characteristics that distinguish patients most likely to respond. Specific Aim #3. Comparison of prostatic bacteria with EPS and seminal fluid (SFA) bacteria. We will test the hypotheses that CP/CPPS patients with prostatic bacteria have similar bacteria in their EPS and/or seminal fluid (SFA) and, further, that these bacteria differ from the bacteria in EPS and/or SFA of controls. Our preliminary studies identified the most common bacteria in CP/CPPS patients' prostatic parenchyma. To show that CP/CPPS patients have similar bacteria in their SFA and/or EPS, we will determine homology of 16S rDNAs in EPS, SFA, and prostate biopsy material from individual patients. To show that these bacteria differ from the bacteria in controls, we will compare l6S rDNAs in SFA and EPS of CP/CPPS with controls. These studies will determine if EPS or SFA can be used to identify prostatic bacteria and may result in clinical methods for non-invasive diagnosis of prostatic infection.
Thesaurus Terms:
bacterial disease, diagnosis design /evaluation, male reproductive system disorder diagnosis, microorganism population study, prostate, prostatitis
bacterial DNA, bacterial RNA, disease /disorder classification, messenger RNA, microorganism classification, pain, ribosomal DNA, urinary tract infection
Escherichia coli, Vibrionaceae, human subject, patient oriented research, polymerase chain reaction
Institution: UNIVERSITY OF WASHINGTON
SEATTLE, WA 98195
Fiscal Year: 2003
Department: UROLOGY
Project Start: 01-AUG-1991
Project End: 31-JAN-2006
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZRG1
Grant Number: 1U01DK065266-01
PI Name: KRIEGER, JOHN N.
PI Email: [email protected]
PI Title: PROFESSOR OF UROLOGY
Project Title: UW/USM Chronic Prostatitis CRC
Abstract: DESCRIPTION (provided by applicant): This proposal, entitled UW/USM Chronic Prostatitis CRC responds to RFA DK-03-004. Prostatitis is a chronic, disabling condition affecting untold numbers of men of all ages and ethnic origins. We will participate in the Chronic Prostatitis Collaborative Research Network (CPCRN). Long-term goals are to prevent and effectively treat this condition. Specific aims are to cooperate and interact with the other clinical centers, the Data Coordinating Center (DCC) and NIDDK staff to: 1) establish a collaborative group of clinical trial centers with expertise in chronic pelvic pain, clinical pain management, and chronic prostatitis 2) design randomized controlled clinical trials to treat the symptoms associated with chronic prostatitis 3) develop and conduct ancillary studies, which will provide further understanding of chronic prostatitis 4) determine if there is a different response to therapy between sub-groups of patients, including newly diagnosed and chronic, long-term patients 5) recruit a sufficient numbers of patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), including an adequate number of newly diagnosed cases 6) jointly work with other CPCRN investigators, including the DCC, to analyze and interpret trial results 7) participate in the Urological Chronic Pelvic Pain Syndromes Collaborative Group (UCPPSCG) and 8) develop a clinically relevant definition of the urologic chronic pelvic pain syndromes, based on the clinical findings from these and other related clinical studies. Previous success in CP/CPPS studies allows us to meet the special requirements for this research including: the ability to recruit (and retain a high proportion of) at least 4-6 participants each month during years 2-4, the ability to recruit newly diagnosed cases, willingness to participate in a collaborative and interactive manner to develop the study protocols (both clinical trial and ancillary studies) and carry out the CPCRN trials, and willingness to participate in the UCPPSCG. We propose the following trial concept for consideration. Prior studies focused on refractory cases from tertiary referral centers. We propose to test the hypothesis that treatment outcomes in newly diagnosed cases are substantially better than in tertiary referral cases. We will screen the general population in Penang, Malaysia for new cases to compare with chronic cases from UW and other tertiary centers. Following clinical evaluation, CP/CPPS patients will be enrolled in a randomized clinical trial with a factorial design comparing alpha-blocker therapy, nonsteroidal anti-inflammatory therapy (or other therapies selected by the CPCRN), the combination, or placebo. Potential outcomes include: symptom indexes (e.g., the NIH-CPSI), urodynamics and inflammation.
Thesaurus Terms:
There are no thesaurus terms on file for this project.
Institution: UNIVERSITY OF WASHINGTON
SEATTLE, WA 98195
Fiscal Year: 2003
Department: UROLOGY
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065187-01
PI Name: MCNAUGHTON-COLLINS, MARY F.
PI Email: [email protected]
PI Title:
Project Title: Chronic Prostatitis Collaborative Clinical Trials
Abstract: DESCRIPTION (provided by applicant): This application reflects a proposal from the Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) / Harvard Medical School to become one of the Clinical Centers of the Chronic Prostatitis Collaborative Research Network (CPCRN) to develop and conduct randomized clinical trials for evaluating novel therapies in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The BWH/MGH Harvard clinical center has a history of successful recruitment and retention of CP/CPPS patients, including a substantial proportion of Latino patients, from the New England area for CPCRN 1997- 2003 - both for the Chronic Prostatitis Cohort Study and Randomized Clinical Trial. Drs. Mary McNaughton Collins and Michael O'Leary have advanced the field of CP/CPPS by helping to develop and validate the NIH-Chronic Prostatitis Symptom Index, translating the index to Spanish, evaluating the quality of life and resource utilization of men with CP/CPPS, as well as examining the epidemiology and natural history of the condition. Dr. McNaughton Collins has also performed several chronic prostatitis studies as a member of the Patient Outcomes Research Team (PORT) for Prostate Diseases and the Cochrane Collaboration. The BWH/MGH Harvard clinical center has expanded to include a multi-institutional and multi-disciplinary network of co-investigators and consultants with both content (i.e., chronic prostatitis, pain management) expertise and methodological (i.e., clinical trials, basic science, and outcomes research) training, as well as fresh sources of chronic prostatitis patients, especially newly diagnosed patients and minority patients. The new reservoirs of CP/CPPS patients include: 1) newly diagnosed CP/CPPS patients from primary care practices and medical walk-in units across the two large institutions and their neighborhood health centers, including the BWH internal medicine Spanish clinic; 2) both newly diagnosed and long-term CP/CPPS patients from the MGH Spanish urology clinic, and; 3) both newly diagnosed and long-term patients from Boston Medical Center, which is a large, inner-city academic health center providing care to a large proportion of African American patients. To assist in the recruitment and retention of Latino men, the site now includes 3 Spanish speaking medicine and urology investigators, and the Research Coordinator is taking Spanish classes to become proficient. This proposal includes a clinical trial design for consideration by the CPCRN. The multi-institutional, multi-disciplinary team from the BWH/MGH Harvard clinical center is eager to collaborate on treatment trials and ancillary studies with other CPCRN centers, the NIH/NIDDK scientific team, and the Interstitial Cystitis Clinical Trials Group.
Thesaurus Terms:
clinical research, clinical trial, experimental design, prostatitis
analgesic, antiinflammatory agent, chronic pain, cooperative study, disease /disorder classification, ethnic group, human therapy evaluation, interdisciplinary collaboration, interstitial cystitis, medical outreach /case finding, pelvis, quality of life, reproductive system disorder chemotherapy, reproductive system pharmacology
human subject, male, patient /disease registry, patient oriented research, questionnaire
Institution: MASSACHUSETTS GENERAL HOSPITAL
55 FRUIT ST
BOSTON, MA 02114
Fiscal Year: 2003
Department:
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1R01DK066641-01
PI Name: WESSELMANN, URSULA
PI Email: [email protected]
PI Title: ASSOCIATE PROFESSOR
Project Title: Pain and Interstitial Cystitis
Abstract: DESCRIPTION (provided by applicant): Interstitial cystitis (IC) is a chronic bladder disease characterized by urinary frequency/urgency and suprapubic pain. There are currently no consistently effective treatments for IC available. The long-range objective of this research is to develop a better understanding of the pathophysiological mechanisms of the pain aspects of IC, in order to develop improved treatment strategies. Clinical, immunologic and neurobiologic characteristics all support the hypothesis that IC is a heterogeneous syndrome. The proposed studies are based on two clinical observations: First, IC shares many characteristics with other chronic visceral pain syndromes. In addition, many patients with IC report extra-bladder pain symptoms, such as gastrointestinal, pelvic and chronic somatic pain. This clinical impression has been confirmed by a series of epidemiological studies. These observations suggest that there might be generalized alterations in pain modulatory mechanisms in IC. Second, IC affects predominantly women in their reproductive ages. This observation suggests that the proposed alterations in nociceptive processing in IC might be further modulated by the gonadal hormonal milieu. The working hypotheses for this proposal are that (1) a spectrum of different insults can lead to chronic pain in patients suffering from IC, (2) different underlying pathogenic pain mechanisms may require different treatment strategies for patients diagnosed with IC, (3) multiple different pathogenic pain mechanisms may coexist in the same patient. The following aims address these hypotheses: Aim 1: We propose to characterize patients with IC in detail using neurophysiological (measures of nociceptive function), autonomic and psychological parameters, urine markers of bladder epithelial function and cytokine profiles (urine, blood). Aim 2: We will determine the influence of the gonadal hormonal milieu on symptoms of the disease in women with IC. We expect that patients with IC can be differentiated into distinct sub-groups, based on the parameters tested. The results of these studies should have rapid clinical implications: if subsets of patients with different IC etiologies can be identified, then they can be targeted for focused research and specific treatments.
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Institution: JOHNS HOPKINS UNIVERSITY
3400 N CHARLES ST
BALTIMORE, MD 21218
Fiscal Year: 2003
Department: NEUROLOGY AND NEUROSURGERY
Project Start: 30-SEP-2003
Project End: 31-AUG-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZRG1
Grant Number: 1P50DK065298-01
PI Name: FREEMAN, MICHAEL R.
PI Email: [email protected]
PI Title: DIRECTOR
Project Title: The HARVARD UROLOGIC RESEARCH CENTER
Abstract: The absence of fundamental knowledge of the genitourinary tract severely limits the development of new and innovative therapeutic options for a variety of common illnesses, including age-related and post-partum urinary incontinence, various forms of bladder instability, urinary tract complications of benign prostatic disease, chronic pelvic pain, and voiding dysfunction originating from congenital anomalies. In the following pages we describe our vision for a research center of excellence in urology, which we have named the Harvard Urologic Research Center (HURC). Our major goal in developing this program has been to assemble an interdisciplinary team of investigators who employ state-of-the-art approaches in basic science and translational research, who have had a history of highly successful collaborative relationships, and who are committed to working together to bring a broad range of technical and scientific expertise to fundamental studies of urological disease. The integrative theme of the HURC is "Tissue Renewal in the Genitourinary Tract". Implicit in this theme is the recognition that many functional deficits observed clinically in urologic practice might be reversed or restored if sufficient knowledge about tissue architecture and remodeling, intercellular circuitry and cell signaling, and other processes characteristic of the cells and tissues of the urogenital system were understood in fundamental terms. The long-range objective of this program will be to integrate knowledge in basic cell biology, tissue engineering, biochemistry, molecular biology, proteomics, and genomics into a scientific network of collaboration that has not existed before. The four "missions" of the HURC will be to: (1) significantly expand the fundamental knowledge of the hollow organs of the urinary tract (ureter, bladder and urethra); (2) direct new, cutting-edge technologies specifically toward clinical urological problems, including cancer; (3) create a center of research and teaching excellence that will attract investigators nationally and internationally; and (4) establish a mentoring environment that will encourage outstanding new investigators to focus on urologic diseases in their career path. To support the "Tissue Renewal" theme, the investigators in the HURC will be clustered within three primary areas of scientific focus that will serve as anchor disciplines for the Center: (1) Tissue Engineering, (2) Signal Transduction and (3) Angiogenesis/Vascular Biology. We seek to create a totally new program in urology research, one that has the potential to develop into one of the strongest and most innovative investigative programs focused on urologic disease in the world.
Thesaurus Terms:
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Institution: CHILDREN'S HOSPITAL (BOSTON)
BOSTON, MA 021155737
Fiscal Year: 2003
Department:
Project Start: 15-SEP-2003
Project End: 31-AUG-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1R01DK066112-01
PI Name: KLUMPP, DAVID J.
PI Email: [email protected]
PI Title:
Project Title: ROLE OF TNF IN BLADDER INFLAMMATION
Abstract: DESCRIPTION (provided by applicant): Interstitial cystitis (IC) is a debilitating, neurogenic bladder disease affecting primarily women with symptoms of pelvic pain, urinary frequency, and urgency. The etiology of IC is unknown, but chronic inflammation is associated with a large subset of patients. Mast cells are thought to play a central role in the bladder inflammation associated with IC, and we have recently shown that mast cells directly induce inflammatory responses in human urothetial cells that are mediated by tumor necrosis factor alpha (TNF). Although little is known about the role of TNF in bladder inflammation, anti-TNF therapy has proven efficacious in the treatment of other chronic inflammatory diseases including Crohn's disease and rheumatoid arthritis. Therefore, our hypothesis is that TNF is a major mediator of bladder inflammation induced by mast cells. To test this hypothesis, we have developed a culture model of mast cell-urothelial cell interactions and a mouse model of neurogenic cystitis using the neurotropic psuedorabies virus (PRV) that does not infect the bladder yet induces a centrally-mediated cystitis that mimics important aspects of IC including voiding dysfunction, involvement of mast ceils, and expression of inflammatory markers. In Aim 1, we will determine the TNF signaling requirements for urothelial inflammatory responses to primary murine mast cells in culture using specific antibodies and RNA interference technologies. In Aim 2, the role of mast cells and TNF in neurogenic cystitis will be determined by infusing wild type and TNF knockout mast cells into mast cell-deficient mice and then inducing cystitis with PRV. Similar experiments will also be performed with TNF receptor knockout mice. In Aim 3, the impact of chronic TNF exposure on bladder inflammation will be assessed using an existing transgenic mouse that expresses elevated systemic TNF and using mouse lines engineered to specifically express TNF in the urothelium. In Aim 4, the effects of anti-TNF therapy will be tested in both the neurogenic and chronic models of TNF-induced bladder inflammation using a TNF blocking antibody. Thus, this project will determine the role of TNF in bladder inflammation and examine a potential therapy for IC.
Thesaurus Terms:
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Institution: NORTHWESTERN UNIVERSITY
Office of Sponsored Programs
CHICAGO, IL 60611
Fiscal Year: 2003
Department: UROLOGY
Project Start: 30-SEP-2003
Project End: 31-JUL-2006
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZRG1
Grant Number: 1U01DK065209-01
PI Name: LANDIS, J RICHARD.
PI Email: [email protected]
PI Title: PROFESSOR
Project Title: Data Coordinating Center for CPCRN and ICCRN
Abstract: DESCRIPTION (provided by applicant): This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to serve as the Data Coordinating Center (DCC) for the Chronic Prostatitis Collaborative Research Network (CPCRN) and the Interstitial Cystitis Clinical Research Network (ICCRN). The proposed DCC will provide administrative, biostatistical, data management and research computing leadership for randomized clinical trials (RCTs) within each of these two collaborative networks. In addition, the DCC will serve as a central link among 20 clinical centers, potentially overlapping for both the CPCRN and ICCRN at a few sites, within the Urological Chronic Pelvic Pain Syndromes Collaborative Group (UCPPSCG), the overarching organization formed to facilitate common protocol and data collection procedures across these two networks. With supplemental funding, the DCC would also provide design, analysis and data coordination support for ancillary studies, as approved by the UCPPSCG. The proposed DCC is uniquely positioned with experience-based scientific, technical and administrative leadership to coordinate new RCTs for the UCPPSCG, currently serving as the DCC for the CPCRN (1997-2003) and the ICCTG (1998-2004), with 10 Clinical Research Centers (CRCs) within each network, as well as the previously funded Interstitial Cystitis Data Base (ICDB) Study (1993-1998). To support these multicenter RCTs, the DCC will provide the technical expertise necessary to design and implement data collection, quality assurance (QA), and reporting via a secure World Wide Web (www)-based data management system (DMS), deployed at the CRCs on existing hardware, to facilitate data entry, verification, validation and query resolution, and data transmission over the internet to servers at the DCC. This DMS will support subject screening and enrollment, randomization and data collection at the CRCs, and tracking of subjects and data at the DCC. The DCC will execute procedures for data security and access, QA, storage, back-up, disaster recovery, and will provide periodic monitoring and QA reports. The DCC will provide the scientific design and analysis, logistical and administrative support by organizing meetings of Steering Committees, coordinating development and distribution of RCT Protocols and Manuals of Operations, and providing the NIDDK Program Office, Steering Committees, and the Data and Safety Monitoring Board (DSMB) with interim and final statistical analyses, and collaboration on all scientific publications
Thesaurus Terms:
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Institution: UNIVERSITY OF PENNSYLVANIA
3451 Walnut Street
PHILADELPHIA, PA 19104
Fiscal Year: 2003
Department: BIOSTATISTICS AND EPIDEMIOLOGY
Project Start: 30-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065277-01
PI Name: SCHAEFFER, ANTHONY J.
PI Email: [email protected]
PI Title: PROFESSOR AND CHAIRMAN
Project Title: Chronic Prostatitis Collaborative Research Network
Abstract: DESCRIPTION (provided by applicant): This proposal is in response to an invitation for a cooperative agreement (contract) for one of ten clinical centers to collaboratively establish, perform, maintain and evaluate multiple therapeutic trials, either sequentially or concurrently for treatments of prostatitis through the collection and analysis of information and clinical samples from patients with the disorder. The long-term objective will be attained by: 1. Developing a protocol(s) and manual of operations through the joint efforts of the Steering Committee consisting of members of the clinical centers, data coordinating center, and the NIDDK project scientist. The investigator from the clinical centers in conjunction with the data coordinating center, will have responsibility in developing the protocol(s). 2. Recruiting and admitting patients into the study who have met agreed upon diagnostic entry criteria, have standard demographic information, symptoms related to prostatitis and who will provide clinical samples collected at established intervals will be enrolled. Northwestern's proposed clinical trial is to conduct a prospective multi-center randomized blinded placebo controlled trial of Saw palmetto (SP) or Pygeum africanum (PA) or placebo in patients with symptoms of chronic pelvic pain syndrome (CPPS). Because of the widespread use of these medications for the treatment of CPPS and lower urinary tract symptoms in men, and the neat total lack of well-performed studies on the efficacy and long-term effects, a placebo controlled trial is needed as defined using the CPCRN criterion.
Thesaurus Terms:
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Institution: NORTHWESTERN UNIVERSITY
633 CLARK ST
EVANSTON, IL 60208
Fiscal Year: 2003
Department: UROLOGY
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065267-01
PI Name: KREDER, KARL J.
PI Email: [email protected]
PI Title:
Project Title: Interstitial Cystitis Clinical Research Network (ICCRN)
Abstract: DESCRIPTION (provided by applicant): The long-term objectives and specific aims of this proposal are to establish the University of Iowa Interstitial Cystitis Research Group as a clinical center in the Interstitial Cystitis Clinical Research Network (ICCRN). The purpose of this network is to establish a collaborative group of centers with expertise in pelvic pain and interstitial cystitis to conduct controlled clinical trials that will provide further understanding of interstitial cystitis. Additionally this network will participate in the Urologic-Chronic Pelvic Pain Syndromes Collaborative Group to conduct trials in chronic prostatitis. A concept protocol using low dose BCG and interferon-alpha(alpha) is included in this proposal. The recruitment, marketing and retention strategies outlined in the following sections will ensure enrollment of between four and six patients per month as well as maximize this center's ability to recruit minority populations. This center has all the clinical and laboratory support as stated in the protocol. The following sections outline innovative methods to recruit both male and female interstitial cystitis patients as well as multiple strategies to ensure long term compliance and completion of all scheduled follow-up visits. In summary, this proposal outlines what we believe are the outstanding credentials of the University of Iowa Interstitial Cystitis Research Group to serve as a Clinical Center in the multi-institutional Interstitial Cystitis Clinical Research Network (ICCRN).
Thesaurus Terms:
clinical research, clinical trial, interstitial cystitis
Mycobacterium bovis, chronic pain, combination chemotherapy, cooperative study, drug screening /evaluation, experimental design, human therapy evaluation, interdisciplinary collaboration, interferon alpha, medical outreach /case finding, outcomes research, pelvis, prostatitis, sign /symptom, urinary tract disorder chemotherapy, urinary tract pharmacology
handbook, human subject, patient oriented research, questionnaire, urinalysis
Institution: UNIVERSITY OF IOWA
IOWA CITY, IA 52242
Fiscal Year: 2003
Department: UROLOGY
Project Start: 01-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065215-01
PI Name: PAYNE, CHRISTOPHER K.
PI Email: [email protected]
PI Title: ASSOCIATE PROFESSOR
Project Title: Interstitial Cystitis Clinical Research Network
Abstract: DESCRIPTION (provided by applicant): This application proposes that Stanford University Center for Female Urology and NeuroUrology participate as one of several National Clinical Centers in a cooperative effort to develop clinical trials for the study of interstitial cystitis (IC). The Principal Investigator intends to participate fully as a member of the steering committee in designing and carrying out multicenter randomized controlled clinical trials (RCTs). The investigative group at Stanford will work in parallel with the centers conducting trials for investigation of chronic prostatitis. A simultaneous application for that effort is being submitted. This is a critical juncture for IC research. While appreciation of the prevalence and impact of the disease is growing, little headway has been made in identifying the underlying etiology or finding reliably effective treatment. More importantly, the very definition of IC and pelvic pain syndromes is under active debate--are all patients with pelvic pain simply varying manifestations of a single underlying disorder or are there important clinical distinctions between IC, vulvadynia, chronic prostatitis, and pelvic floor dysfunction? The relevance of standard diagnostic tools has been challenged. Bladder distention under anesthesia may be neither sensitive nor specific. Neither urodynamic testing nor bladder biopsy provides specific diagnostic information. A simple office trial of intravesical potassium instillation purported to identify IC totally failed to predict response to therapy in a RCT. These and other critical issues will only be settled by carefully designed, large scale RCTs. The ICCRN should focus on the following specific aims: 1) determining the clinical utility of currently diagnostic tests for IC and evaluating new tests 2) developing evidence based algorithms for the work-up of IC patients involved in clinical research 3) developing relevant clinical protocols that involve the entire spectrum of IC patients 4) to test novel therapies for IC as they become available. Stanford is ideally suited for this project due to a long history of interest in IC, a Principal Investigator with recognized expertise in clinical research, an ethnically diverse patient base, and demonstrable success recruiting patients for IC research.
Thesaurus Terms:
clinical research, clinical trial, experimental design, human therapy evaluation, interstitial cystitis, urinary tract disorder chemotherapy
chronic pain, cooperative study, diagnosis design /evaluation, diagnosis quality /standard, drug screening /evaluation, interdisciplinary collaboration, mathematical model, methadone, model design /development, outcomes research, quality of life, urinary tract pharmacology
human subject, patient oriented research
Institution: STANFORD UNIVERSITY
STANFORD, CA 94305
Fiscal Year: 2003
Department: UROLOGY
Project Start: 01-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1U01DK065268-01
PI Name: ALEXANDER, RICHARD B.
PI Email: [email protected]
PI Title: PROFESSOR
Project Title: Chronic prostatitis collaborative clinical studies
Abstract: DESCRIPTION (provided by applicant): Chronic prostatitis/chronic pelvic pain syndrome is a common but poorly understood condition affecting men of all ages. Infection has dominated the thinking about this disease for decades. However, a growing body of evidence provides significant challenge to the notion that infection contributes to symptoms in a significant proportion of patients. Much of this new information was developed by the Chronic Prostatitis Collaborative Research Network (CPCRN), a six year project representing the first NIH-funded collaborative study of chronic prostatitis. The long-term goal of this application is the continuation of our involvement in the Chronic Prostatitis Collaborative Research Network. In addition, we will collaborate with investigators studying interstitial cystitis under an umbrella group, the Urological Chronic Pelvic Pain Syndromes Collaborative Group. We describe the activities at our center over the past 7 years in the study of chronic prostatitis/chronic pelvic pain syndrome and describe the clinical and research infrastructure and expertise that we propose to continue to apply to the study of chronic prostatitis/chronic pelvic pain syndrome as part of this cooperative group.
Thesaurus Terms:
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Institution: UNIVERSITY OF MARYLAND BALT PROF SCHOOL
BALTIMORE, MD 21201
Fiscal Year: 2003
Department: SURGERY
Project Start: 05-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
Grant Number: 1R01DK066658-01
PI Name: PEZZONE, MICHAEL A.
PI Email: [email protected]
PI Title:
Project Title: Neurogenic Pathogenesis of Interstitial Cystitis
Abstract: DESCRIPTION (provided by applicant): Chronic pelvic pain is a poorly understood but sufficiently debilitating clinical condition primarily affecting women. Few diagnostic and treatment options are available for this understudied patient population, which is estimated at 9.2 million in the United States. The causes of chronic pelvic pain are numerous but may involve gynecologic, urologic, gastrointestinal, musculoskeletal, neuronal, or psychological origins as well as combinations thereof. The urinary bladder and colorecmm are two of the larger pelvic organs thought to be affected primarily in these disorders, and thus, it is not surprising that interstitial cystitis (IC) and irritable bowel syndrome (IBS) are two of the commonest causes of chronic pelvic pain. The observed overlap of chronic pelvic pain disorders such as IC and IBS suggests a common underlying etiology or even cross-organ (neurogenic) sensitization. Using a newly developed rodent model for studying afferent-mediated interactions of the pelvic organs in the rat, we will investigate the hypothesis that chronic irritation of the distal colon may adversely influence and sensitize urinary bladder afferents leading to neurogenic cystitis and its associated physiologic sequelae. The studies proposed in this application will attempt to shed more light on the overlap and etiology of chronic pelvic pain syndromes and the role of cross-organ, afferent sensitization.
Thesaurus Terms:
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Institution: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
350 THACKERAY HALL
PITTSBURGH, PA 15260
Fiscal Year: 2003
Department: MEDICINE
Project Start: 30-SEP-2003
Project End: 31-JUL-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZRG1
Grant Number: 1U01DK065213-01
PI Name: BURKS, DAVID A.
PI Email: [email protected]
PI Title: SENIOR STAFF UROLOGISTS
Project Title: Interstitial Cystitis Clinical Research Network
Abstract: DESCRIPTION (provided by applicant): Interstitial cystitis is a chronic debilitating disease characterized by urinary frequency, urgency and bladder pain. Despite the first descriptions of this disease by Guy Hunner in 1914, it still remains "The Great Enigma." The disease continues to defy a consensus definition, a definable pathophysiology or a reliably effective treatment. Multiple theories of pathogenesis have spawned a myriad of mostly ineffective treatments. Many physicians either doubt, or are unaware of the existence of this disease causing significant delay in diagnosis for many patients, especially men and children, where the disease is most poorly characterized. Since 1987 the NIH has begun a systematic, evidence-based effort to define interstitial cystitis determine its biochemical and clinical characteristics and evaluate novel therapies. Beginning with the NIDDK Workshop and Consensus Conference, the definition of interstitial cystitis has evolved from a restrictive instrument used for research papers, to a more inclusive criteria developed by the Interstitial Cystitis Data Base Group. The Interstitial Cystitis Clinical Trials Group proved that a collaborative multi-center group could recruit patients into rigorous, novel treatment protocols. The major objective of this grant is to develop the Interstitial Cystitis Clinical Research Network to continue the evolution in characterizing this disease. We propose evaluating a novel therapy, IPD-1151T, an immune system modulator with possible efficacy in interstitial cystitis patients. A published pilot study showed significant improvement in symptom scores with minimal side effects. The ICCRN will work in collaboration with the Chronic Prostatitis Clinical Research Network to investigate interstitial cystitis as a subset of chronic pelvic pain disorders of the bladder. A coordinated effort to develop common patient evaluation and treatment protocols, will allow an overarching analysis of these urologic pain syndromes.
Thesaurus Terms:
clinical research, clinical trial, experimental design, human therapy evaluation, immunomodulator, interstitial cystitis, urinary tract disorder chemotherapy
chronic pain, community health service, cooperative study, disease /disorder etiology, ethnic group, health education, interdisciplinary collaboration, medical outreach /case finding, outcomes research, pelvis, urinary tract pharmacology
human subject, patient oriented research, statistics /biometry, videotape /videodisc
Institution: CASE WESTERN RESERVE UNIV-HENRY FORD HSC
RESEARCH ADMINISTRAION CFP-046
DETROIT, MI 48202
Fiscal Year: 2003
Department: UROLOGY
Project Start: 01-SEP-2003
Project End: 28-FEB-2008
ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG: ZDK1
