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Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
This study has been terminated.
( Poor recruitment, poor patient compliance, lack of funding )
Study NCT00317070   Information provided by Capital District Health Authority, Canada
First Received: April 20, 2006   Last Updated: May 8, 2009   History of Changes

April 20, 2006
May 8, 2009
April 2006
February 2009   (final data collection date for primary outcome measure)
reduction of frequency of micturition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
reduction of frequency of micturition
Complete list of historical versions of study NCT00317070 on ClinicalTrials.gov Archive Site
  • 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 ]
  • reduction in pain
  • overall improvement of symptoms
 
Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
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)

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.

 
Phase II
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
  • Interstitial Cystitis
  • Bladder Diseases
  • Drug: dimethyl sulfoxide
  • Drug: IC Cocktail
Active Comparator: Intravesical installation
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
10
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00317070
Jerzy B Gajewski, Capital District Health Authority, Canada
CDHA010
Capital District Health Authority, Canada
 
Principal Investigator: Jerzy Gajewski, MD, FRCSC Capital District Health Authority
Capital District Health Authority, Canada
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP