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Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)

This study is currently recruiting participants.
Study NCT00317070.   Last updated on May 30, 2008.   Information provided by Capital District Health Authority, Canada

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Descriptive Information Fields
Brief Title  Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
Official Title  A Randomized Controlled Trial to Evaluate the Efficacy and Tolerability of Intravesical Cocktail and Comparison With Intravesical Dimethyl Sulfoxide (DMSO) for the Treatment of Painful Bladder Syndrome Including Interstitial Cystitis (PBS/IC)
Brief Summary

The primary objective of this study is to evaluate the efficacy and tolerability of the intravesical cocktail and its comparison with intravesical DMSO in a controlled trial for the treatment of painful bladder syndrome including interstitial cystitis.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  reduction of frequency of micturition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  reduction in pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
overall improvement of symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Condition  Interstitial Cystitis
Bladder Diseases
Intervention  Drug: dimethyl sulfoxide
Drug: IC Cocktail
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  April 2006
Completion Date April 2009
Eligibility Criteria 

Inclusion Criteria:

  1. Participants should be of age eighteen years or older
  2. Participant has painful bladder syndrome and a score of 8 or greater on the painful bladder syndrome symptom index (O'Leary-Sant)
  3. Participant should have frequency and urgency of micturition and bladder pain for at least 6 months
  4. Participant should have voids at least 8 times during a 24 hour period and at least once during the night as documented in the voiding diary and questionnaire.
  5. Urine culture should not show any evidence of urinary tract infection.
  6. Participant should be able to understand, speak, and read English.
  7. Participant should be willing to take part in the study, including signing this form after carefully reading it.
  8. Participant consents to use a medically acceptable method of birth control throughout the entire study period and for four weeks after the study is completed. Medically acceptable methods of contraception that may be used by the study participants and/or their partners include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical sterilization, vasectomy, or progestin implants or injections.
  9. Failure of other treatments for PBS/IC like pentosan polysulfate (failure is defined as a score of +1 [slightly improved] or less on a global assessment response [GRA] 23 question to previous therapy)

Exclusion Criteria:

  1. Participants who have undergone cystoscopy within 4 weeks of screening visit
  2. Participants had other treatment given into the bladder in the past 4 weeks
  3. Participants have used a new drug in the past 4 weeks which could affect bladder symptoms (some antidepressants, anticholinergics, antihistamines)
  4. Past history of treatment with cyclophosphamide
  5. A positive pregnancy test at the time of screening
  6. Currently breast feeding
  7. History of uterine, cervical, or vaginal cancer during the past 3 years
  8. History of significant vaginitis
  9. History of major surgery in the last 6 months
  10. Positive tests for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV)
  11. History of immune deficiency diseases
  12. History of bleeding disorders
  13. History of serious social, mental, or medical conditions that would stop patient from taking part in the study
  14. History of alcohol or drug abuse within the last 5 years
  15. Participants who have history of prostate cancer or are being treated for chronic bacterial prostatitis
  16. History of liver disease or significant medical problem which the investigator considers a risk for patient to be a part of the study
  17. History of any of the following: neurogenic bladder radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi, or active genital herpes within 3 months of screening
  18. Known hypersensitivity to one of the agents used in the intravesical instillation
  19. Use of any investigational drug or device in the last 6 months
  20. Participants who are unwilling or unable to abide by the requirements of the study
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Jerzy Gajewski, MD, FRCSC     902-473-8679     jgajew@dal.ca    
Contact: Jacob Puthenparumpil, MD     902-473-3844     jputhenp@dal.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00317070
Organization ID CDHA010
Secondary IDs ††
Study Sponsor  Capital District Health Authority, Canada
Collaborators ††
Investigators 
Principal Investigator:     Jerzy Gajewski, MD, FRCSC     Capital District Health Authority    
Information Provided By Capital District Health Authority, Canada
Verification Date May 2008
First Received Date  April 20, 2006
Last Updated Date May 30, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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