The MAPP research network: a novel study of urologic chronic pelvic pain syndromes

J Quentin Clemens, Chris Mullins, John W Kusek, Ziya Kirkali, Emeran A Mayer, Larissa V Rodríguez, David J Klumpp, Anthony J Schaeffer, Karl J Kreder, Dedra Buchwald, Gerald L Andriole, M Scott Lucia, J Richard Landis, Daniel J Clauw, MAPP Research Network Study Group, J Quentin Clemens, Ziya Kirkali, John W Kusek, J Richard Landis, M Scott Lucia, Chris Mullins, Michel A Pontari, David J Klumpp, Anthony J Schaeffer, Apkar Vania Apkarian, David Cella, Melissa A Farmer, Colleen Fitzgerald, Richard Gershon, James W Griffith, Charles J Heckman 2nd, Mingchen Jiang, Laurie Keefer, Darlene S Marko, Jean Michniewicz, Todd Parrish, Frank Tu, A Mayer, Larissa V Rodríguez, Jeffry Alger, Cody P Ashe-McNalley, Ben Ellingson, Nuwanthi Heendeniya, Lisa Kilpatrick, Jason Kutch, Jennifer S Labus, Bruce D Naliboff, Fornessa Randal, Suzanne R Smith, Karl J Kreder, Catherine S Bradley, Mary Eno, Kris Greiner, Yi Luo, Susan K Lutgendorf, Michael A O'Donnell, Barbara Ziegler, Daniel J Clauw, J Quentin Clemens, Suzie As-Sanie, Sandra Berry, Megan E Halvorson, Richard Harris, Steve Harte, Eric Ichesco, Ann Oldendorf, Katherine A Scott, David A Williams, Dedra Buchwald, Niloofar Afari, John Krieger, Jane Miller, Stephanie Richey, Susan O Ross, Roberta Spiro, T J Sundsvold, Eric Strachan, Claire C Yang, Gerald L Andriole, H Henry Lai, Rebecca L Bristol, Graham Colditz, Georg Deutsch, Vivien C Gardner, Robert W Gereau 4th, Jeffrey P Henderson, Barry A Hong, Thomas M Hooton, Timothy J Ness, Carol S North, Theresa M Spitznagle, Siobhan Sutcliffe, J Richard Landis, Ted Barrell, Philip Hanno, Xiaoling Hou, Tamara Howard, Michel A Pontari, Nancy Robinson, Alisa Stephens, Yanli Wang, M Scott Lucia, Adrie van Bokhoven, Andrea A Osypuk, Robert Dayton Jr, Karen R Jonscher, Holly T Sullivan, R Storey Wilson, Garth D Ehrlich, Marsha A Moses, Andrew C Briscoe, David Briscoe, Adam Curatolo, John Froehlich, Richard S Lee, Monisha Sachdev, Keith R Solomon, Hanno Steen, Sean Mackey, Epifanio Bagarinao, Lauren C Foster, Emily Hubbard, Kevin A Johnson, Katherine T Martucci, Rebecca L McCue, Rachel R Moericke, Aneesha Nilakantan, Noorulain Noor, J Curtis Nickel, Chris Mullins, John W Kusek, Ziya Kirkali, Tamara G Bavendam, J Quentin Clemens, Chris Mullins, John W Kusek, Ziya Kirkali, Emeran A Mayer, Larissa V Rodríguez, David J Klumpp, Anthony J Schaeffer, Karl J Kreder, Dedra Buchwald, Gerald L Andriole, M Scott Lucia, J Richard Landis, Daniel J Clauw, MAPP Research Network Study Group, J Quentin Clemens, Ziya Kirkali, John W Kusek, J Richard Landis, M Scott Lucia, Chris Mullins, Michel A Pontari, David J Klumpp, Anthony J Schaeffer, Apkar Vania Apkarian, David Cella, Melissa A Farmer, Colleen Fitzgerald, Richard Gershon, James W Griffith, Charles J Heckman 2nd, Mingchen Jiang, Laurie Keefer, Darlene S Marko, Jean Michniewicz, Todd Parrish, Frank Tu, A Mayer, Larissa V Rodríguez, Jeffry Alger, Cody P Ashe-McNalley, Ben Ellingson, Nuwanthi Heendeniya, Lisa Kilpatrick, Jason Kutch, Jennifer S Labus, Bruce D Naliboff, Fornessa Randal, Suzanne R Smith, Karl J Kreder, Catherine S Bradley, Mary Eno, Kris Greiner, Yi Luo, Susan K Lutgendorf, Michael A O'Donnell, Barbara Ziegler, Daniel J Clauw, J Quentin Clemens, Suzie As-Sanie, Sandra Berry, Megan E Halvorson, Richard Harris, Steve Harte, Eric Ichesco, Ann Oldendorf, Katherine A Scott, David A Williams, Dedra Buchwald, Niloofar Afari, John Krieger, Jane Miller, Stephanie Richey, Susan O Ross, Roberta Spiro, T J Sundsvold, Eric Strachan, Claire C Yang, Gerald L Andriole, H Henry Lai, Rebecca L Bristol, Graham Colditz, Georg Deutsch, Vivien C Gardner, Robert W Gereau 4th, Jeffrey P Henderson, Barry A Hong, Thomas M Hooton, Timothy J Ness, Carol S North, Theresa M Spitznagle, Siobhan Sutcliffe, J Richard Landis, Ted Barrell, Philip Hanno, Xiaoling Hou, Tamara Howard, Michel A Pontari, Nancy Robinson, Alisa Stephens, Yanli Wang, M Scott Lucia, Adrie van Bokhoven, Andrea A Osypuk, Robert Dayton Jr, Karen R Jonscher, Holly T Sullivan, R Storey Wilson, Garth D Ehrlich, Marsha A Moses, Andrew C Briscoe, David Briscoe, Adam Curatolo, John Froehlich, Richard S Lee, Monisha Sachdev, Keith R Solomon, Hanno Steen, Sean Mackey, Epifanio Bagarinao, Lauren C Foster, Emily Hubbard, Kevin A Johnson, Katherine T Martucci, Rebecca L McCue, Rachel R Moericke, Aneesha Nilakantan, Noorulain Noor, J Curtis Nickel, Chris Mullins, John W Kusek, Ziya Kirkali, Tamara G Bavendam

Abstract

Urologic chronic pelvic pain syndrome (UCPPS) may be defined to include interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The hallmark symptom of UCPPS is chronic pain in the pelvis, urogenital floor, or external genitalia often accompanied by lower urinary tract symptoms. Despite numerous past basic and clinical research studies there is no broadly identifiable organ-specific pathology or understanding of etiology or risk factors for UCPPS, and diagnosis relies primarily on patient reported symptoms. In addition, there are no generally effective therapies. Recent findings have, however, revealed associations between UCPPS and "centralized" chronic pain disorders, suggesting UCPPS may represent a local manifestation of more widespread pathology in some patients. Here, we describe a new and novel effort initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the U.S. National Institutes of Health (NIH) to address the many long standing questions regarding UCPPS, the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. The MAPP Network approaches UCPPS in a systemic manner, in which the interplay between the genitourinary system and other physiological systems is emphasized. The network's study design expands beyond previous research, which has primarily focused on urologic organs and tissues, to utilize integrated approaches to define patient phenotypes, identify clinically-relevant subgroups, and better understand treated natural history and pathophysiology. Thus, the MAPP Network provides an unprecedented, multi-layered characterization of UCPPS. Knowledge gained is expected to provide important insights into underlying pathophysiology, a foundation for better segmenting patients for future clinical trials, and ultimately translation into improved clinical management. In addition, the MAPP Network's integrated multi-disciplinary research approach may serve as a model for studies of urologic and non-urologic disorders that have proven refractory to past basic and clinical study.

Trial registration: ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)".

References

    1. Bogart LM, Berry SH, Clemens JQ. Symptoms of interstitial cystitis, painful bladder syndrome and similar diseases in women: a systematic review. J Urol. 2007;177(2):450–456. doi: 10.1016/j.juro.2006.09.032.
    1. Clemens JQ, Markossian TW, Meenan RT, O’Keeffe Rosetti MC, Calhoun EA. Overlap of voiding symptoms, storage symptoms and pain in men and women. J Urol. 2007;178(4 Pt 1):1354–8. discussion 1358.
    1. Simon LJ, Landis JR, Erickson DR, Nyberg LM. The interstitial cystitis data base study: concepts and preliminary baseline descriptive statistics. Urology. 1997;49(5A Suppl):64–75.
    1. Propert KJ, Schaeffer AJ, Brensinger CM, Kusek JW, Nyberg LM, Landis JR. A prospective study of interstitial cystitis: results of longitudinal followup of the interstitial cystitis data base cohort: the interstitial cystitis data base study group. J Urol. 2000;163(5):1434–1439. doi: 10.1016/S0022-5347(05)67637-9.
    1. Sant GR, Propert KJ, Hanno PM, Burks D, Culkin D, Diokno AC, Hardy C, Landis JR, Mayer R, Madigan R, Messing EM, Peters K, Theoharides TC, Warren J, Wein AJ, Steers W, Kusek JW, Nyberg LM. Interstitial Cystitis Clinical Trials Group. A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. J Urol. 2003;170(3):810–815. doi: 10.1097/01.ju.0000083020.06212.3d.
    1. Mayer R, Propert KJ, Peters KM, Payne CK, Zhang Y, Burks D, Culkin DJ, Diokno A, Hanno P, Landis JR, Madigan R, Messing EM, Nickel JC, Sant GR, Warren J, Wein AJ, Kusek JW, Nyberg LM, Foster HE. Interstitial Cystitis Clinical Trials Group. A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis. J Urol. 2005;173(4):1186–1191. doi: 10.1097/01.ju.0000152337.82806.e8.
    1. Propert KJ, Mayer RD, Wang Y, Sant GR, Hanno PM, Peters KM, Kusek JW. Interstitial Cystitis Clinical Trials Group. Responsiveness of symptom scales for interstitial cystitis. Urology. 2006;67(1):55–59. doi: 10.1016/j.urology.2005.07.014.
    1. Propert KJ, Mayer R, Nickel JC, Payne CK, Peters KM, Teal V, Burks D, Kusek JW, Nyberg LM, Foster HE. Interstitial Cystitis Clinical Trials Group. Did patients with interstitial cystitis who failed to respond to initial treatment with bacillus calmette-guerin or placebo in a randomized clinical trial benefit from a second course of open label bacillus calmette-guerin? J Urol. 2007;178(3 Pt 1):886–890.
    1. Propert KJ, Mayer R, Nickel JC, Payne CK, Peters KM, Teal V, Burks D, Kusek JW, Nyberg LM, Foster HE. Interstitial Cystitis Clinical Trials Group. Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo. J Urol. 2008;179(2):552–555. doi: 10.1016/j.juro.2007.09.035.
    1. Foster HE Jr, Hanno PM, Nickel JC, Payne CK, Mayer RD, Burks DA, Yang CC, Chai TC, Kreder KJ, Peters KM, Lukacz ES, Fitzgerald MP, Cen L, Landis JR, Propert KJ, Yang W, Kusek JW, Nyberg LM. Interstitial Cystitis Collaborative Research Network. Effect of amitriptyline on symptoms in treatment naive patients with interstitial cystitis/painful bladder syndrome. J Urol. 2010;183(5):1853–1858. doi: 10.1016/j.juro.2009.12.106.
    1. Yang CC, Burks DA, Propert KJ, Mayer RD, Peters KM, Nickel JC, Payne CK, FitzGerald MP, Hanno PM, Chai TC, Kreder KJ, Lukacz ES, Foster HE, Cen L, Landis JR, Kusek JW, Nyberg LM. Interstitial Cystitis Collaborative Research Network. Early termination of a trial of mycophenolate mofetil for treatment of interstitial cystitis/painful bladder syndrome: lessons learned. J Urol. 2011;185(3):901–906. doi: 10.1016/j.juro.2010.10.053.
    1. FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM. Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012;187(6):2113–2118. doi: 10.1016/j.juro.2012.01.123.
    1. Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O’Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM. Chronic Prostatitis Collaborative Research Network Group. Demographic and clinical characteristics of men with chronic prostatitis: the National Institutes of Health chronic prostatitis cohort study. J Urol. 2002;168(2):593–598. doi: 10.1016/S0022-5347(05)64686-1.
    1. Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O’Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS. Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004;141(8):581–589.
    1. Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O’Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ. Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008;359(25):2663–2673. doi: 10.1056/NEJMoa0803240.
    1. Nickel JC, Alexander RB, Anderson R, Berger R, Comiter CV, Datta NS, Fowler JE, Krieger JN, Landis JR, Litwin MS, McNaughton-Collins M, O’Leary MP, Pontari MA, Schaeffer AJ, Shoskes DA, White P, Kusek J, Nyberg L. Chronic Prostatitis Collaborative Research Network Study Group. Category III chronic prostatitis/chronic pelvic pain syndrome: insights from the National Institutes of Health Chronic Prostatitis Collaborative Research Network studies. Curr Urol Rep. 2008;9(4):320–327. doi: 10.1007/s11934-008-0055-7.
    1. Pontari MA, Krieger JN, Litwin MS, White PC, Anderson RU, McNaughton-Collins M, Nickel JC, Shoskes DA, Alexander RB, O’Leary M, Zeitlin S, Chuai S, Landis JR, Cen L, Propert KJ, Kusek JW, Nyberg LM Jr, Schaeffer AJ. Chronic Prostatitis Collaborative Research Network-2. Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med. 2010;170(17):1586–1593. doi: 10.1001/archinternmed.2010.319.
    1. FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O’Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013;189(1):S75–S85. doi: 10.1016/j.juro.2012.11.018.
    1. Clemens JQ, Link CL, Eggers PW, Kusek JW, Nyberg LM Jr, McKinlay JB. BACH Survey Investigators. Prevalence of painful bladder symptoms and effect on quality of life in black, Hispanic and white men and women. J Urol. 2007;177(4):1390–1394. doi: 10.1016/j.juro.2006.11.084.
    1. Link CL, Pulliam SJ, Hanno PM, Hall SA, Eggers PW, Kusek JW, McKinlay JB. Prevalence and psychosocial correlates of symptoms suggestive of painful bladder syndrome: results from the Boston area community health survey. J Urol. 2008;180(2):599–606. doi: 10.1016/j.juro.2008.04.009.
    1. Barry MJ, Link CL, McNaughton-Collins MF, McKinlay JB. Boston Area Community Health (BACH) Investigators. Overlap of different urological symptom complexes in a racially and ethnically diverse, community-based population of men and women. BJU Int. 2008;101(1):45–51.
    1. Berry SH, Elliott MN, Suttorp M, Bogart LM, Stoto MA, Eggers P, Nyberg L, Clemens JQ. Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States. J Urol. 2011;186(2):540–544. doi: 10.1016/j.juro.2011.03.132.
    1. Suskind AM, Berry SH, Ewing BA, Elliott MN, Suttorp MJ, Clemens JQ. The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study. J Urol. 2013;189(1):141–145. doi: 10.1016/j.juro.2012.08.088.
    1. Warren JW, Wesselmann U, Morozov V, Langenberg PW. Numbers and types of nonbladder syndromes as risk factors for interstitial cystitis/painful bladder syndrome. Urology. 2011;77(2):313–319. doi: 10.1016/j.urology.2010.08.059.
    1. Warren JW, Howard FM, Cross RK, Good JL, Weissman MM, Wesselmann U, Langenberg P, Greenberg P, Clauw DJ. Antecedent nonbladder syndromes in case–control study of interstitial cystitis/painful bladder syndrome. Urology. 2009;73(1):52–57. doi: 10.1016/j.urology.2008.06.031.
    1. Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997;31(1):125–131. doi: 10.1016/S0022-3956(96)00051-9.
    1. Heitkemper M, Jarrett M. Overlapping conditions in women with irritable bowel syndrome. Urol Nurs. 2005;25(1):25–30. quiz 31.
    1. Aaron LA, Herrell R, Ashton S, Belcourt M, Schmaling K, Goldberg J, Buchwald D. Comorbid clinical conditions in chronic fatigue: a co-twin control study. J Gen Intern Med. 2001;16(1):24–31.
    1. Clemens JQ, Meenan RT, O’Keeffe Rosetti MC, Kimes TA, Calhoun EA. Case–control study of medical comorbidities in women with interstitial cystitis. J Urol. 2008;179(6):2222–2225. doi: 10.1016/j.juro.2008.01.172.
    1. Rodriguez MA, Afari N, Buchwald DS. National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol. 2009;182(5):2123–2131. doi: 10.1016/j.juro.2009.07.036.
    1. Nickel JC. The multidisciplinary approach to defining the urologic chronic pelvic pain syndromes: report from a National Institutes of Health workshop, December 13–14, 2007, Baltimore. MD Rev Urol. 2008;10(2):157–159.
    1. Fillingim RB, Ohrbach R, Greenspan JD, Knott C, Dubner R, Bair E, Baraian C, Slade GD, Maixner W. Potential psychosocial risk factors for chronic TMD: descriptive data and empirically identified domains from the OPPERA case–control study. J Pain. 2011;12(11 Suppl):T46–60.
    1. Landis JR, Williams DA, Lucia MS, Clauw DJ, Naliboff BD, Robinson NA, van Bokhoven A, Sutcliffe S, Schaeffer AJ, Rodriguez LV, Mayer EA, Lai HH, Krieger JN, Kreder KJ, Afari N, Andriole GL, Bradley CS, Griffith JW, Klumpp DJ, Hong BA, Lutgendorf SK, Buchwald D, Yang CC, Mackey S, Pontari MA, Hanno P, Kusek JW, Mullins C, Clemens JQ, The MAPP Research Network Study Group. The MAPP research network: design, patient characterization, and operations. Accepted to BMC Urology on 23 July 2014.
    1. Shoskes DA, Nickel JC, Dolinga R, Prots D. Clinical phenotyping of patients with chronic prostatitis/chronic pelvic pain syndrome and correlation with symptom severity. Urology. 2009;73(3):538–42. doi: 10.1016/j.urology.2008.09.074. discussion 542–3.
    1. Nickel JC, Shoskes D, Irvine-Bird K. Clinical phenotyping of women with interstitial cystitis/painful bladder syndrome: a key to classification and potentially improved management. J Urol. 2009;182(1):155–160. doi: 10.1016/j.juro.2009.02.122.

Source: PubMed

3
Iratkozz fel