Interstitial Cystitis Clinical Research Network (ICCRN)

Summary

Principal Investigator: G R Sant
Abstract: The objectives of this proposal are the initiation and development of the Interstitial Cystitis Clinical Research Network (ICCRN) and the performance of randomized controlled multicenter clinical trials for the treatment of interstitial cystitis (IC). These objectives will be achieved by: (a) development and design of medical treatment protocols for IC and a manual of operations in conjunction with a Steering Committee consisting of the Clinical Centers, the Data Coordinating Center and the NIDDK Project Scientist. (b) recruitment and retention of patients who meet agreed upon Clinical Trials entry criteria The Specific Aims of the proposal are: (a) to assess the therapeutic effectiveness of drug (approved, investigational, other) and non-drug treatment of IC in well-characterized cohorts of IC patients (newly diagnosed, chronic, minority populations) (b) to utilize validated and meaningful treatment outcome measures (eg., SF-36 health-related quality of life; the O'Leary-Sant Symptom/Problem Index, global response assessment (GRA) (c) recruitment of a minimum of 50 patients/year for 4 years (total 200 patients). The Principal Investigator (Dr. Grannum R. Sant, has a 20 year experience in the diagnosis and treatment of IC and has a large IC patient population within his clinical practice. (d) there will be an initial 12 month period of collaborative protocol/manual of operations development, followed by 48 months of patient recruitment with concurrent data analysis and reporting. (e) coordinate protocol development and clinical outcomes analyses with the Chronic Prostatitis Clinical Research Network (CPCRN) under the umbrella of the Urological Chronic Pain Syndromes Collaborative Network (UCPPSCG). The data obtained from these randomized controlled studies will define the effectiveness of various therapies for IC and improve the quality of life of patients suffering from IC. The collaboration with the UCPPSCG will better define the urological pelvic pain syndromes (male and female) and lead to better classification and treatment outcomes.
Funding Period: 2003-09-01 - 2004-08-31
more information: NIH RePORT

Top Publications

  1. ncbi Corticotropin-releasing hormone-receptor 2 is required for acute stress-induced bladder vascular permeability and release of vascular endothelial growth factor
    William Boucher
    Molecular Immunopharmacology and Drug Discovery Laboratory, Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Boston, MA 02111, USA
    BJU Int 106:1394-9. 2010
  2. ncbi Immunomodulators for treatment of interstitial cystitis
    Theoharis C Theoharides
    Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts New England Medical Center, Boston, Massachusetts 02111, USA
    Urology 65:633-8. 2005
  3. ncbi Acute stress and intravesical corticotropin-releasing hormone induces mast cell dependent vascular endothelial growth factor release from mouse bladder explants
    J Cao
    Department of Biochemistry, Tufts University School of Medicine, Tufts New England Medical Center, 136 Harrison Avenue, Boston, MA 02111, USA
    J Urol 176:1208-13. 2006
  4. ncbi Treatment approaches for painful bladder syndrome/interstitial cystitis
    Theoharis C Theoharides
    Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Tufts New England Medical Center, Boston, Massachusetts, USA
    Drugs 67:215-35. 2007
  5. ncbi Intravesical suplatast tosilate (IPD-1151T) inhibits experimental bladder inflammation
    W Boucher
    Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts New England Medical Center, Boston, Massachusetts 02111, USA
    J Urol 177:1186-90. 2007
  6. ncbi Interstitial cystitis: bladder pain and beyond
    Theoharis C Theoharides
    Tufts University School of Medicine, Department of Pharmacology and Experimental Therapeutics, Experimental Therapeutics 136 Harrison Avenue, Boston, MA 02111, USA
    Expert Opin Pharmacother 9:2979-94. 2008

Scientific Experts

  • Theoharis Theoharides
  • W Boucher
  • J Cao
  • William Boucher
  • D Kempuraj
  • Margaret Michaelian
  • Duraisamy Kempuraj
  • D Papaliodis
  • J M Donelan

Detail Information

Publications6

  1. ncbi Corticotropin-releasing hormone-receptor 2 is required for acute stress-induced bladder vascular permeability and release of vascular endothelial growth factor
    William Boucher
    Molecular Immunopharmacology and Drug Discovery Laboratory, Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Boston, MA 02111, USA
    BJU Int 106:1394-9. 2010
    ....
  2. ncbi Immunomodulators for treatment of interstitial cystitis
    Theoharis C Theoharides
    Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts New England Medical Center, Boston, Massachusetts 02111, USA
    Urology 65:633-8. 2005
  3. ncbi Acute stress and intravesical corticotropin-releasing hormone induces mast cell dependent vascular endothelial growth factor release from mouse bladder explants
    J Cao
    Department of Biochemistry, Tufts University School of Medicine, Tufts New England Medical Center, 136 Harrison Avenue, Boston, MA 02111, USA
    J Urol 176:1208-13. 2006
    ..We investigated the effect of intravesical corticotropin-releasing hormone and acute restraint stress on vascular endothelial growth factor release from mouse bladder explants and the role of mast cells...
  4. ncbi Treatment approaches for painful bladder syndrome/interstitial cystitis
    Theoharis C Theoharides
    Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Tufts New England Medical Center, Boston, Massachusetts, USA
    Drugs 67:215-35. 2007
    ..Pilot clinical trials suggest that the flavonoid quercetin may be helpful. Lack of early diagnosis and treatment can affect outcomes and leads to the development of hyperalgesia/allodynia...
  5. ncbi Intravesical suplatast tosilate (IPD-1151T) inhibits experimental bladder inflammation
    W Boucher
    Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts New England Medical Center, Boston, Massachusetts 02111, USA
    J Urol 177:1186-90. 2007
    ..We investigated the effect of intravesical IPD-1151T on mediator release from bladder explants in experimental cystitis...
  6. ncbi Interstitial cystitis: bladder pain and beyond
    Theoharis C Theoharides
    Tufts University School of Medicine, Department of Pharmacology and Experimental Therapeutics, Experimental Therapeutics 136 Harrison Avenue, Boston, MA 02111, USA
    Expert Opin Pharmacother 9:2979-94. 2008
    ..Interstitial cystitis occurs primarily in females including adolescents and its diagnosis is still one of exclusion. It is now recognized as a serious medical condition associated with significant disability...