INTERSTITIAL CYSTITIS TRIALS GROUP
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
- A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitisRobert 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)...
- Immunomodulators for treatment of interstitial cystitisTheoharis 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
- Responsiveness of symptom scales for interstitial cystitisK J Propert
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 6021, USA
Urology 67:55-9. 2006....
- Treatment approaches for painful bladder syndrome/interstitial cystitisTheoharis 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...
- Sexual function is a determinant of poor quality of life for women with treatment refractory interstitial cystitisJ 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...
- 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....
- 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...
- Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placeboKathleen 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...
- Interstitial cystitis: bladder pain and beyondTheoharis 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...