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

NCT00317070 | Terminated Phase 2

• 1 other identifier: CDHA010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

PBS/IC; Painful bladder syndrome including Interstitial cystitis

Outcome Measures

Primary Outcomes (1)

• reduction of frequency of micturition

  16 weeks

Secondary Outcomes (2)

• reduction in pain

  16 weeks

• overall improvement of symptoms

  16 weeks

Study Arms (2)

DMSO

ACTIVE COMPARATOR

Intravesical installation

Drug: dimethyl sulfoxide

Cocktail

EXPERIMENTAL

Drug: IC Cocktail

Interventions

dimethyl sulfoxide DRUG

intravesical installation 50 ml

DMSO

IC Cocktail 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

Cocktail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants should be of age eighteen years or older
• Participant has painful bladder syndrome and a score of 8 or greater on the painful bladder syndrome symptom index (O'Leary-Sant)
• Participant should have frequency and urgency of micturition and bladder pain for at least 6 months
• 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.
• Urine culture should not show any evidence of urinary tract infection.
• Participant should be able to understand, speak, and read English.
• Participant should be willing to take part in the study, including signing this form after carefully reading it.
• 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.
• 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)

You may not qualify if:

• Participants who have undergone cystoscopy within 4 weeks of screening visit
• Participants had other treatment given into the bladder in the past 4 weeks
• Participants have used a new drug in the past 4 weeks which could affect bladder symptoms (some antidepressants, anticholinergics, antihistamines)
• Past history of treatment with cyclophosphamide
• A positive pregnancy test at the time of screening
• Currently breast feeding
• History of uterine, cervical, or vaginal cancer during the past 3 years
• History of significant vaginitis
• History of major surgery in the last 6 months
• Positive tests for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV)
• History of immune deficiency diseases
• History of bleeding disorders
• History of serious social, mental, or medical conditions that would stop patient from taking part in the study
• History of alcohol or drug abuse within the last 5 years
• Participants who have history of prostate cancer or are being treated for chronic bacterial prostatitis

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Dept. of Urology, Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Urinary Bladder Diseases

Interventions

Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Cystitis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Officials

• Jerzy Gajewski, MD, FRCSC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: April 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 11, 2009

Record last verified: 2008-05

Locations

CA (1)