Painful Bladder SyndromeNCT00150488
URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
A study testing Uracyst in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Dr. J. Curtis Nickel at 1 site in Canada.
Trial summary
This protocol describes a multi-centre, community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the treatment of patients with a clinical diagnosis of interstitial cystitis (IC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Painful Bladder Syndrome, Interstitial Cystitis
- What is being tested?
- Uracyst
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following eligibility criteria in order to be enrolled in this study.
- Clinical diagnosis of interstitial cystitis
- Legally majority female capable and willing to provide informed consent
- Negative blood test for pregnancy at baseline or assurance of previous surgery, condition or state rendering conception impossible
- A sterile bacterial urine culture no more than thirty (30) days prior to first treatment
- An average urinary frequency of at least 11 times per 24-hour day
- An average pain/discomfort score of 4 or greater on a 0-10cm VAS scale
- Available for the duration of the study including treatment and follow-up (4 months)
Who cannot join
- Pregnant or lactating
- Currently receiving or having received investigational drugs thirty (30) days or less prior to screening
- Currently receiving or having had prior therapy with intravesical treatment (eg. Uracyst, Cystistat®, heparin or BCG)
- Receiving therapy for less than three months with antidepressants, antihistaminics, hormonal agonists or antagonists; hence patient not stabilized on therapy. (Stable therapy defined as continuous treatment for at least three months.)
- Currently receiving or having received prior therapy with oral pentosanpolysulfate (Elmiron) 3 months or less prior to screening
- IC symptoms relieved by antimicrobials, anticholinergics or antispasmodics
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- Bladder capacity of greater than 500 ml on awake cystometry using liquid filling medium
- Neurologic disease affecting bladder function; any previous surgery or procedure having affected bladder function
- Current urinary tract infection (must be treated and have a negative culture before study entry)
- Current diagnosis of chemical, tuberculous or radiation cystitis
- History of bladder or lower ureteral calculi
- History of cancer within the last five years other than adequately treated non-melanoma skin cancers
- Active sexual transmitted disease
- Current vaginitis
- Endometriosis
- Any condition/disease which in the opinion of the investigator could interfere with patient compliance and/ or interfere with the interpretation of the treatment results
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Advanced Urological Research, Kingston General Hospital
Kingston, Ontario, K7L 3N6
About this study
This protocol describes a multi-centre, community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the treatment of patients with a clinical diagnosis of interstitial cystitis (IC).
The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests.
Read the detailed description
The primary efficacy endpoint will be the percent responders to treatment as indicated by improvement on a seven-point Patient Global Assessment scale at week 10 (after 6 treatments) compared to baseline. The patient evaluates the overall change in their condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse.
Secondary efficacy objectives will be as follows:
- Improvement in individual IC symptoms during the treatment period and at week 10 (after 6 treatments) compared to baseline. Pain and urgency scores (0-10 cm VAS) will be obtained using patient on-site questionnaires prior to first treatment (baseline), and again for weeks 4, 6, 10, 14, 18, 22 and 24.
- Change in Patient Symptom/Problem Index scores over the course of the treatment until the end of study (week 24) compared to baseline. The validated O'Leary Symptom Problem/Index will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24. The validated PUF questionnaire will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.
- Change in patient condition every month throughout the therapy and treatment follow-up.
In addition to measuring the change in patient condition at week 14, the Patient Global Assessment will be completed at weeks 4, 6, 10, 14, 18, 22 and 24.
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis
- Being tested
- Uracyst
- Keywords
- PBS, Painful Bladder Syndrome, Interstitial Cystitis, chrondroitin sulfate
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UracystDevice
Also called chondroitin sulphate
2% weekly for 6 weeks, monthly for 4 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Uracyst® single arm open label Treatment Group Receives: Device: Uracyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders to Treatment
indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline
Measured: Week 10 (4 weeks after the initial six treatments
Secondary outcomes (1)
Change in Likert Pain Score From Baseline at 10 Weeks
Scale of 0-10; subjects report 0=no pain and 10 pain as bad as you can imagine.
Measured: Baseline and 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Painful Bladder SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uracyst
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. J. Curtis Nickel
- Sponsor type
- University, hospital or other
- Collaborators
- Stellar Pharmaceuticals
- Responsible party
- Sponsor-investigator, Dr. J. Curtis Nickel, Queen's University
- Investigators
- Curtis Nickel, MD FRCSC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150488
- Sponsor's protocol ID
- Uracyst-Stellar
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2005
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT00150488
- Acronym / sponsor ID
- Uracyst-Stellar
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis
- Keywords
- PBS, Painful Bladder Syndrome, Interstitial Cystitis, chrondroitin sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Dr. J. Curtis NickelUniversity, hospital or other
- Collaborators
- Stellar Pharmaceuticals
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol describes a multi-centre, community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the treatment of patients with a clinical diagnosis of interstitial cystitis (IC).
The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests.
Detailed description
The primary efficacy endpoint will be the percent responders to treatment as indicated by improvement on a seven-point Patient Global Assessment scale at week 10 (after 6 treatments) compared to baseline. The patient evaluates the overall change in their condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse.
Secondary efficacy objectives will be as follows:
- Improvement in individual IC symptoms during the treatment period and at week 10 (after 6 treatments) compared to baseline. Pain and urgency scores (0-10 cm VAS) will be obtained using patient on-site questionnaires prior to first treatment (baseline), and again for weeks 4, 6, 10, 14, 18, 22 and 24.
- Change in Patient Symptom/Problem Index scores over the course of the treatment until the end of study (week 24) compared to baseline. The validated O'Leary Symptom Problem/Index will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24. The validated PUF questionnaire will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.
- Change in patient condition every month throughout the therapy and treatment follow-up.
In addition to measuring the change in patient condition at week 14, the Patient Global Assessment will be completed at weeks 4, 6, 10, 14, 18, 22 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uracyst
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: UracystUracyst® single arm open label Treatment Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must meet the following eligibility criteria in order to be enrolled in this study.
- Clinical diagnosis of interstitial cystitis
- Legally majority female capable and willing to provide informed consent
- Negative blood test for pregnancy at baseline or assurance of previous surgery, condition or state rendering conception impossible
- A sterile bacterial urine culture no more than thirty (30) days prior to first treatment
Key exclusion criteria (16 listed)
- Pregnant or lactating
- Currently receiving or having received investigational drugs thirty (30) days or less prior to screening
- Currently receiving or having had prior therapy with intravesical treatment (eg. Uracyst, Cystistat®, heparin or BCG)
- Receiving therapy for less than three months with antidepressants, antihistaminics, hormonal agonists or antagonists; hence patient not stabilized on therapy. (Stable therapy defined as continuous treatment for at least three months.)
- Currently receiving or having received prior therapy with oral pentosanpolysulfate (Elmiron) 3 months or less prior to 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 |
|---|---|---|
| UracystAlso: chondroitin sulphate2% weekly for 6 weeks, monthly for 4 months | Device | 1 |
Primary outcome
Percentage of Responders to Treatment
Time frame: Week 10 (4 weeks after the initial six treatments
indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline
1 secondary outcome
Change in Likert Pain Score From Baseline at 10 Weeks
Time frame: Baseline and 10 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Curtis Nickel, MD FRCSC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uracyst in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Dr. J. Curtis Nickel 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 27 Jul 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Responders to Treatment (time frame: Week 10 (4 weeks after the initial six treatments). 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 27 Jul 2023.