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CHONDROITIN SULFATE SODIUM

Interstitial Cystitis (IC) and Painful Bladder Syndrome (PBS) are chronic bladder conditions that cause pain and discomfort. Recent clinical trials have been investigating Uracyst, a medical device containing 2% sodium chondroitin sulfate, as a potential treatment option. This article explores a specific clinical trial that compared Uracyst to an inactive control in patients with IC/PBS. The study involved eight weekly bladder instillations over seven weeks, with follow-up evaluations for an additional 19 weeks. We’ll look at how this treatment was administered, what researchers were measuring, and how this information might benefit patients seeking relief from these challenging conditions.

Table of Contents

What is Chondroitin Sulfate Sodium?

Chondroitin Sulfate Sodium is a medical compound used to treat certain bladder conditions. It’s marketed under the brand name Uracyst as a 2% solution specifically designed for bladder instillation (a procedure where medication is directly placed into the bladder)[1]. This treatment is considered a medical device that helps repair the protective lining of the bladder wall that may be damaged in certain bladder conditions.

Conditions Treated

Uracyst is specifically designed to treat two closely related conditions[1]:

  • Interstitial Cystitis (IC) – A chronic bladder condition that causes bladder pressure, bladder pain, and sometimes pelvic pain. The pain can range from mild discomfort to severe pain. The condition is also marked by a frequent and urgent need to urinate.
  • Painful Bladder Syndrome (PBS) – A condition with symptoms similar to interstitial cystitis, characterized by pain in the bladder that increases as the bladder fills and is relieved after urination.

These conditions can significantly impact quality of life, causing discomfort and disrupting daily activities due to frequent urination needs and pain[1].

How Uracyst is Administered

Chondroitin Sulfate Sodium (Uracyst) is administered directly into the bladder through a procedure called intravesical instillation[1]. During this procedure:

  1. A healthcare provider inserts a small catheter through the urethra into the bladder
  2. 20 mL of the 2% sodium chondroitin sulfate solution is delivered through the catheter into the bladder
  3. The solution remains in the bladder for a period of time before being expelled naturally through urination

This direct application allows the medication to come into contact with the bladder lining, where it is believed to help repair damage to the protective layer of the bladder wall[1].

Clinical Research

Uracyst has been studied in clinical trials to evaluate its safety and effectiveness. One significant study was a multi-center, randomized, double-blind trial that compared Uracyst to an inactive control (placebo)[1].

In this study design:

  • Multi-center – The study was conducted at multiple medical facilities to ensure diverse patient representation
  • Randomized – Patients were randomly assigned to either receive Uracyst or the placebo
  • Double-blind – Neither the patients nor the healthcare providers knew which treatment was being administered
  • Parallel group – One group received Uracyst while another group received the inactive control (placebo)

The placebo used in the study was phosphate-buffered saline, which is the same buffer used in Uracyst but without the active ingredient (sodium chondroitin sulfate)[1]. This design helps researchers determine if any improvements are due to the medication itself or simply the process of receiving treatment.

Measuring Effectiveness

The effectiveness of Uracyst was measured using standardized assessment tools[1]:

  • Global Response Assessment (GRA) – This is a tool where patients rate their overall improvement. In the study, “responders” were defined as subjects who indicated their condition was “markedly improved” or “moderately improved.” This was the primary way researchers determined if the treatment was working.
  • Interstitial Cystitis Symptom Index (ICSI) – This is a questionnaire that measures the severity of IC/PBS symptoms. “Responders” on this measure were subjects who showed at least a 30% improvement from their baseline (starting) score.

These measurements were taken at Week 11 of the study, which was after the completion of all treatments[1]. The term “LOCF” (Last Observation Carried Forward) mentioned in the study indicates that if a participant dropped out before Week 11, their last recorded measurement was used in the final analysis.

Treatment Course

The treatment schedule for Uracyst involves[1]:

  • 8 weekly bladder instillations administered over a 7-week period
  • Each instillation consists of 20 mL of 2% sodium chondroitin sulfate solution
  • After the treatment period, patients were followed for an additional 19 weeks
  • The total study duration was 26 weeks (approximately 6 months)

This extended follow-up period allows researchers to assess both the immediate and long-term effects of the treatment, including how long any improvements might last after the treatment course is completed[1].

Feature Description
Treatment Name Uracyst (2% sodium chondroitin sulfate)
Conditions Treated Interstitial Cystitis, Painful Bladder Syndrome
Administration Method 20 mL intravesical (bladder) instillation
Treatment Schedule 8 weekly instillations over a 7-week period
Control Group Inactive control (phosphate-buffered saline)
Total Study Duration 26 weeks (7 weeks treatment + 19 weeks follow-up)
Primary Outcome Measure Global Response Assessment (GRA) at Week 11
Secondary Outcome Measure Interstitial Cystitis Symptom Index (ICSI) at Week 11
Study Design Multi-center, randomized, double-blind, parallel group

FAQ

  • What is Uracyst and how was it used in the clinical trial? Uracyst is a medical device containing 2% sodium chondroitin sulfate. In the clinical trial, it was administered as a 20 mL bladder instillation (a solution placed directly into the bladder) once weekly for a total of 8 treatments over a 7-week period. This treatment was compared to an inactive control solution (phosphate-buffered saline) administered in the same way.
  • What conditions was Uracyst being tested to treat? Uracyst was being tested as a treatment for Interstitial Cystitis (IC) and Painful Bladder Syndrome (PBS). These are chronic bladder conditions characterized by bladder pain, pressure, discomfort, and urinary frequency. They can significantly impact quality of life for those affected.
  • How long did the clinical trial last? The clinical trial lasted a total of 26 weeks (about 6 months). This included 7 weeks of active treatment with 8 weekly instillations, followed by a 19-week follow-up period to monitor longer-term effects after the treatment had ended.
  • How did researchers measure whether Uracyst was effective? The primary way researchers measured effectiveness was using the Global Response Assessment (GRA) at Week 11. Patients who reported their condition as 'markedly improved' or 'moderately improved' were considered responders to the treatment. They also measured improvement using the Interstitial Cystitis Symptom Index (ICSI), where a 30% improvement from baseline was considered a positive response.
  • What type of study design was used in this clinical trial? This was a multi-center, randomized, double-blind, parallel group study. 'Multi-center' means it took place at multiple medical facilities. 'Randomized' means patients were randomly assigned to either the Uracyst or control group. 'Double-blind' means neither the patients nor the researchers directly interacting with them knew which treatment was being given. 'Parallel group' means the two groups received their respective treatments simultaneously rather than crossing over between treatments.

Ongoing Clinical Trials on CHONDROITIN SULFATE SODIUM

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    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
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Glossary

  • Interstitial Cystitis (IC): A chronic bladder condition that causes bladder pressure, bladder pain, and sometimes pelvic pain. The pain ranges from mild discomfort to severe pain. The condition is part of a spectrum of diseases known as painful bladder syndrome.
  • Painful Bladder Syndrome (PBS): A condition that causes bladder pain, pressure, or discomfort that lasts for more than 6 weeks without another identifiable cause, such as infection or kidney stones.
  • Sodium Chondroitin Sulfate: A chemical that is normally found in the layer that protects the bladder wall. In IC/PBS, this protective layer may be damaged, and sodium chondroitin sulfate is thought to help repair or replace this layer.
  • Intravesical Instillation: A medical procedure where a solution is placed directly into the bladder through a catheter. In this study, either Uracyst or the control solution was administered this way.
  • Global Response Assessment (GRA): A tool used to measure a patient's overall response to treatment. Patients rate their condition on a scale from 'markedly worse' to 'markedly improved'.
  • Interstitial Cystitis Symptom Index (ICSI): A questionnaire that measures the severity of symptoms associated with interstitial cystitis, including urgency, frequency, and pain.
  • Double-blind: A type of clinical study design where neither the participants nor the researchers directly interacting with them know which treatment is being given. This helps prevent bias in reporting outcomes.
  • Randomized: A process in clinical trials where participants are assigned by chance to different treatment groups. This helps create groups that are similar at the start of the trial.
  • Placebo Comparator: A substance or procedure that looks like the treatment being tested but doesn't contain the active ingredient. In this study, a phosphate-buffered saline solution was used as the inactive control.
  • LOCF (Last Observation Carried Forward): A method used in clinical trials to handle missing data. If a participant drops out of the study, their last recorded measurement is used for subsequent timepoints.
  • Phosphate-buffered Saline: A buffer solution commonly used in biological research that helps maintain a constant pH. In this study, it was used as the inactive control solution.
  • Outcomes Assessor: A person involved in a clinical trial who evaluates the results or outcomes of the treatment. In this study, the outcomes assessors were masked (didn't know which treatment each participant received).

References

  1. https://clinicaltrials.gov/study/NCT00919113