Clinical trial NCT00317070 (phase 2, status: terminated)
Conditions: interstitial cystitis, bladder diseases
ICD codes: N30.10, N30.11
Drugs: dimethyl sulfoxide, ic cocktail
SMILES: CS(C)=O, CNC[C@H](O)C1=CC(O)=C(O)C=C1
Reason stopped: 
    poor recruitment, poor patient compliance, lack of funding
  
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