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

Nova Scotia Health Authority (NSHA)

Status and phase

Terminated

Phase 2

Conditions

Interstitial Cystitis

Bladder Diseases

Treatments

Drug: IC Cocktail

Drug: dimethyl sulfoxide

Study type

Interventional

Funder types

Other

Identifiers

NCT00317070

CDHA010

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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
History of liver disease or significant medical problem which the investigator considers a risk for patient to be a part of the study
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
Known hypersensitivity to one of the agents used in the intravesical instillation
Use of any investigational drug or device in the last 6 months
Participants who are unwilling or unable to abide by the requirements of the study