INTERSTITIAL CYSTITIS TRIALS GROUP

Summary

Principal Investigator: G R Sant
Abstract: DESCRIPTION: (Abstract of the application) The primary objectives of this proposal are the initiation of an Interstitial Cystitis (IC) Trials Group and the performance of randomized, controlled multi-center studies therapies for IC utilizing validated treatment outcomes measures. The 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 and Planning Committee consisting of the Clinical Centers, the Data Coordinating Center and the NIDDK Project Scientist. b) recruitment and retention of patients who meet the agreed upon Clinical Trials entry criteria. The specific aims of the proposal are: a) to assess the therapeutic effectiveness of drugs (approved, investigational, other) and non-drug treatment of IC in well-characterized cohorts of IC patients; (b) to utilize validated and meaningful treatment outcome measures (e.g., SF-36 health-relate quality of life; the IC Symptom/Problem Index);c) recruitment of a minimum of 50 patients/year for 4 years (total 200 patients). The Principal Investigator (Dr. Grannum R. Sant, Tufts University School of Medicine) and Co-investigator (Dr. Edward Messing, University of Rochester), both have >10 years experience in the diagnosis and treatment of IC and have large patient populations within their clinical practices; 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. The data obtained from these randomized controlled studies will define the effectivenes of various therapies for IC and improve the quality of life of patients suffering from IC.
Funding Period: 1998-05-10 - 2004-02-28
more information: NIH RePORT

Top Publications

  1. ncbi A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis
    Robert Mayer
    University of Rochester, Rochester, New York, USA
    J Urol 173:1186-91. 2005
  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 Responsiveness of symptom scales for interstitial cystitis
    K J Propert
    University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
    Urology 67:55-9. 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 Sexual function is a determinant of poor quality of life for women with treatment refractory interstitial cystitis
    J Curtis Nickel
    Department of Urology, Queen s University, Kingston General Hospital, Kingston, Ontario, Canada
    J Urol 177:1832-6. 2007
  6. ncbi 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?
    Kathleen Joy Propert
    Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, 6th Floor, 423 Guardian Dr, Philadelphia, Pennsylvania 19104, USA
    J Urol 178:886-90. 2007
  7. ncbi Prospective evaluation of candidate urine and cell markers in patients with interstitial cystitis enrolled in a randomized clinical trial of Bacillus Calmette Guerin (BCG)
    Susan Keay
    Department of Medicine, University of Maryland School of Medicine, 10 N Greene Street, Baltimore, MD 21201, USA
    World J Urol 25:499-504. 2007
  8. pmc Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo
    Kathleen Joy Propert
    University of Pennsylvania, Philadelphia, Pennsylvania, USA
    J Urol 179:552-5. 2008
  9. 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
  • J C Nickel
  • Susan Keay
  • K J Propert
  • Robert Mayer
  • Christopher K Payne
  • Grannum R Sant
  • John W Kusek
  • J Richard Landis
  • Alan J Wein
  • Ananias Diokno
  • Harris E Foster
  • David Burks
  • Daniel J Culkin
  • Leroy M Nyberg
  • Kenneth M Peters
  • Yawei Zhang
  • Edward M Messing
  • Philip Hanno
  • John Warren
  • Rosemary Madigan

Detail Information

Publications9

  1. ncbi A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis
    Robert Mayer
    University of Rochester, Rochester, New York, USA
    J Urol 173:1186-91. 2005
    ..We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC)...
  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 Responsiveness of symptom scales for interstitial cystitis
    K J Propert
    University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
    Urology 67:55-9. 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
    ..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 Sexual function is a determinant of poor quality of life for women with treatment refractory interstitial cystitis
    J Curtis Nickel
    Department of Urology, Queen s University, Kingston General Hospital, Kingston, Ontario, Canada
    J Urol 177:1832-6. 2007
    ..Interstitial cystitis significantly negatively impacts quality of life. The demographic and clinical factors associated with decreased quality of life in these patients have not been well studied...
  6. ncbi 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?
    Kathleen Joy Propert
    Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, 6th Floor, 423 Guardian Dr, Philadelphia, Pennsylvania 19104, USA
    J Urol 178:886-90. 2007
    ....
  7. ncbi Prospective evaluation of candidate urine and cell markers in patients with interstitial cystitis enrolled in a randomized clinical trial of Bacillus Calmette Guerin (BCG)
    Susan Keay
    Department of Medicine, University of Maryland School of Medicine, 10 N Greene Street, Baltimore, MD 21201, USA
    World J Urol 25:499-504. 2007
    ..Changes in HDF and HB-EGF levels correlated weakly with changes in urgency, but the low BCG response rate prevented identification of additional associations between biomarker changes and treatment or symptoms...
  8. pmc Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo
    Kathleen Joy Propert
    University of Pennsylvania, Philadelphia, Pennsylvania, USA
    J Urol 179:552-5. 2008
    ..We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo in a randomized clinical trial...
  9. 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...