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.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZDK1-GRB-1 (M3))
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Kusek, John W
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Queen's University at Kingston
Zip Code
K7 3-N6
Tripp, Dean A; Nickel, J Curtis; Pikard, Jennifer L et al. (2012) Chronic prostatitis-like symptoms in African males aged 16-19 years. Can J Urol 19:6081-7
Ginting, Jessica V; Tripp, Dean A; Nickel, J Curtis (2011) Self-reported spousal support modifies the negative impact of pain on disability in men with chronic prostatitis/chronic pelvic pain syndrome. Urology 78:1136-41
Pontari, Michel A; Krieger, John N; Litwin, Mark S et al. (2010) Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med 170:1586-93
Tripp, Dean A; Nickel, J Curtis; Ross, Stephanie et al. (2009) Prevalence, symptom impact and predictors of chronic prostatitis-like symptoms in Canadian males aged 16-19 years. BJU Int 103:1080-4
Nickel, J Curtis; Krieger, John N; McNaughton-Collins, Mary et al. (2008) Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med 359:2663-73
Nickel, J Curtis (2008) Inflammation and benign prostatic hyperplasia. Urol Clin North Am 35:109-15;vii
Nickel, J Curtis; Mullins, Chris; Tripp, Dean A (2008) Development of an evidence-based cognitive behavioral treatment program for men with chronic prostatitis/chronic pelvic pain syndrome. World J Urol 26:167-72
Nickel, J Curtis (2008) Treatment of chronic prostatitis/chronic pelvic pain syndrome. Int J Antimicrob Agents 31 Suppl 1:S112-6
Smith, Kelly B; Tripp, Dean; Pukall, Caroline et al. (2007) Predictors of sexual and relationship functioning in couples with Chronic Prostatitis/Chronic Pelvic Pain Syndrome. J Sex Med 4:734-44
Smith, Kelly B; Pukall, Caroline F; Tripp, Dean A et al. (2007) Sexual and relationship functioning in men with chronic prostatitis/chronic pelvic pain syndrome and their partners. Arch Sex Behav 36:301-11