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

NCT ID: NCT00317070

Last Updated: 2009-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-02-28

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.

Conditions

Interstitial Cystitis; Bladder Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DMSO

Intravesical installation

Group Type: ACTIVE_COMPARATOR

dimethyl sulfoxide

Intervention Type: DRUG

intravesical installation 50 ml

Cocktail

Group Type: EXPERIMENTAL

IC Cocktail

Intervention Type: DRUG

• Heparin 10,000 units
• Gentamicin 80 mg
• Hydrocortisone sodium succinate (Solucortef) 100 mg
• Lidocaine hydrochloride 1% 10 ml
• Sodium Bicarbonate 8.4% 5 ml

Interventions

dimethyl sulfoxide

intravesical installation 50 ml

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Capital District Health Authority, Canada

Principal Investigators

Jerzy Gajewski, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Dept. of Urology, Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CDHA010

Identifier Type: -

Identifier Source: org_study_id