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

Interstitial Cystitis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00317070
• Other study ID #: CDHA010
• Status: Terminated
• Phase: Phase 2
• First received: April 20, 2006
• Last updated: May 8, 2009
• Start date: April 2006
• Est. completion date: February 2009

Study information

• Verified date: May 2008
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Diseases
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Urinary Bladder Diseases

Intervention

Drug:
• dimethyl sulfoxide
intravesical installation 50 ml
• 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

Locations

Country	Name	City	State
Canada	Dept. of Urology, Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of frequency of micturition		16 weeks	No
Secondary	reduction in pain		16 weeks	No
Secondary	overall improvement of symptoms		16 weeks	No