Interstitial CystitisPhase 2NCT00317070
Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
A Phase 2 study testing dimethyl sulfoxide and IC Cocktail in people with Interstitial Cystitis and Bladder Diseases, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Bladder Diseases
- What is being tested?
- dimethyl sulfoxide and IC Cocktail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dept. of Urology, Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: 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.
- Conditions
- Interstitial Cystitis, Bladder Diseases
- Being tested
- dimethyl sulfoxide, IC Cocktail
- Keywords
- PBS/IC, Painful bladder syndrome including Interstitial cystitis
- Medical subject headings
- Cystitis, Interstitial, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl sulfoxideDrug
intravesical installation 50 ml
IC CocktailDrug
- Heparin 10,000 units
- Gentamicin 80 mg
- Hydrocortisone sodium succinate (Solucortef) 100 mg
- Lidocaine hydrochloride 1% 10 ml
- Sodium Bicarbonate 8.4% 5 ml
| Study group | Role | What they receive |
|---|---|---|
| DMSO | Active comparator | Intravesical installation Receives: Drug: dimethyl sulfoxide |
| Cocktail | Experimental | Not described Receives: Drug: IC Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of frequency of micturition
Measured: 16 weeks
Secondary outcomes (2)
reduction in pain
Measured: 16 weeks
overall improvement of symptoms
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Poor recruitment, poor patient compliance, lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Investigators
- Jerzy Gajewski, MD, FRCSC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317070
- Sponsor's protocol ID
- CDHA010
- Status last verified
- May 2008
- First submitted
- 20 Apr 2006
- Last updated
- 11 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00317070
- Acronym / sponsor ID
- CDHA010
- Conditions
- Interstitial Cystitis, Bladder Diseases
- Keywords
- PBS/IC, Painful bladder syndrome including Interstitial cystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment, poor patient compliance, lack of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMSO | Active comparator | Drug: dimethyl sulfoxideIntravesical installation |
| Cocktail | Experimental | Drug: IC Cocktail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dimethyl sulfoxideintravesical installation 50 ml | Drug | DMSO |
| 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 | Drug | Cocktail |
Primary outcome
reduction of frequency of micturition
Time frame: 16 weeks
2 secondary outcomes
reduction in pain
Time frame: 16 weeks
overall improvement of symptoms
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Poor recruitment, poor patient compliance, lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy Gajewski, MD, FRCSC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dimethyl sulfoxide and IC Cocktail in people with Interstitial Cystitis and Bladder Diseases, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment, poor patient compliance, lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of frequency of micturition (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2009.