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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.
Verified by Capital District Health Authority, Canada, May 2008

Sponsored by: Capital District Health Authority, Canada
Information provided by: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00317070
  Purpose

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.


Condition Intervention Phase
Interstitial Cystitis
Bladder Diseases
Drug: dimethyl sulfoxide
Drug: IC Cocktail
Phase II

MedlinePlus related topics:   Bladder Diseases   Interstitial Cystitis  

ChemIDplus related topics:   Hydrocortisone   Cortisol 21-phosphate   Cortisol succinate   Hydrocortamate   Hydrocortisone 21-sodium succinate   Hydrocortisone acetate   Hydrocortisone cypionate   Hydrocortisone hemisuccinate   Proctofoam-HC   Succinic acid   Heparin   Gentamicins   Lidocaine   Sodium bicarbonate   Dimethyl sulfoxide  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • reduction of frequency of micturition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   40
Study Start Date:   April 2006
Estimated Study Completion Date:   April 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
DMSO: Active Comparator
Intravesical installation
Drug: dimethyl sulfoxide
intravesical installation 50 ml
Cocktail: Experimental Drug: IC Cocktail
  • Heparin 10,000 units
  • Gentamicin 80 mg
  • Hydrocortisone sodium succinate (Solucortef) 100 mg
  • Lidocaine hydrochloride 1% 10 ml
  • Sodium Bicarbonate 8.4% 5 ml

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317070

Contacts
Contact: Jerzy Gajewski, MD, FRCSC     902-473-8679     jgajew@dal.ca    
Contact: Jacob Puthenparumpil, MD     902-473-3844     jputhenp@dal.ca    

Locations
Canada, Nova Scotia
Dept. of Urology, Queen Elizabeth II Health Sciences Center     Recruiting
      Halifax, Nova Scotia, Canada, B3H 3A7
      Principal Investigator: Jerzy Gajewski, MD, FRCSC            
      Sub-Investigator: Jacob Puthenparumpil, MD            
      Sub-Investigator: Greg Bailly, MD, FRCSC            
      Sub-Investigator: Swarna Weerasinghe, PhD            
      Sub-Investigator: Stephen Steele, MD            

Sponsors and Collaborators
Capital District Health Authority, Canada

Investigators
Principal Investigator:     Jerzy Gajewski, MD, FRCSC     Capital District Health Authority    
  More Information

Responsible Party:   Capital District Health Authority, Canada ( Jerzy B Gajewski )
Study ID Numbers:   CDHA010
First Received:   April 20, 2006
Last Updated:   May 30, 2008
ClinicalTrials.gov Identifier:   NCT00317070
Health Authority:   Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
PBS/IC  
Painful bladder syndrome including Interstitial cystitis  

Study placed in the following topic categories:
Dimethyl Sulfoxide
Cystitis, Interstitial
Hydrocortisone
Cortisol succinate
Gentamicins
Urinary Bladder Diseases
Lidocaine
Cystitis
Pain
Hydrocortisone acetate
Heparin
Calcium heparin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Cryoprotective Agents
Protective Agents
Anesthetics, Local
Pharmacologic Actions
Pathologic Processes
Urologic Diseases
Sensory System Agents
Syndrome
Therapeutic Uses
Free Radical Scavengers
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 03, 2008




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