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.

Study Overview

• Status: Terminated
• Conditions: Interstitial Cystitis; Bladder Diseases
• Intervention / Treatment: Drug: dimethyl sulfoxide; Drug: IC Cocktail

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Dept. of Urology, Queen Elizabeth II Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DMSO; Intravesical installation	Drug: dimethyl sulfoxide; intravesical installation 50 ml
Experimental: Cocktail	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduction of frequency of micturition	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
reduction in pain	16 weeks
overall improvement of symptoms	16 weeks

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Jerzy Gajewski, MD, FRCSC, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: April 20, 2006
• First Submitted That Met QC Criteria: April 20, 2006
• First Posted (Estimate): April 24, 2006

Study Record Updates

• Last Update Posted (Estimate): May 11, 2009
• Last Update Submitted That Met QC Criteria: May 8, 2009
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: PBS/IC; Painful bladder syndrome including Interstitial cystitis
• Additional Relevant MeSH Terms: Urologic Diseases; Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Free Radical Scavengers; Cryoprotective Agents; Dimethyl Sulfoxide
• Other Study ID Numbers: CDHA010