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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Interstitial Cystitis, Bladder Diseases

Intervention / Treatment
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* Drug: dimethyl sulfoxide
* Drug: IC Cocktail


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DMSO<br>Intravesical installation | Drug: dimethyl sulfoxide<br>* intravesical installation 50 ml<br>|
| Experimental: Cocktail<br> | Drug: IC Cocktail<br>* Heparin 10,000 units Gentamicin 80 mg Hydrocortisone sodium succinate (Solucortef) 100 mg Lidocaine hydrochloride 1% 10 ml Sodium Bicarbonate 8.4% 5 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of frequency of micturition |  | 16 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PBS/IC, Painful bladder syndrome including Interstitial cystitis