A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527917

Enrollment

Registered

2007-09-11

Start date

2007-09-30

Completion date

2008-09-30

Last updated

2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis

Keywords

IC/PBS, Interstitial Cystitis/Painful Bladder Syndrome

Brief summary

This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.

Interventions

DEVICEplacebo

bladder instillation

DEVICEUracyst

20 ml sterile solution for weekly intravesical instillation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Are female of male patient 18 years or older * Have been previously diagnosed with IC/PBS. * Are willing to provide informed consent * Available for the duration of the study including treatment and follow-up (12 weeks)

Exclusion criteria

* Pregnant or lactating female. * Are currently or have previously received investigational drugs within thirty (30) days of screening. * Previous therapy for IC/PBS * Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results. * Are unable or unwilling to comply with protocol requirements * Are unable to read, understand, and provide written informed consent.

Design outcomes

Primary

Measure	Time frame
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis	Baseline to 6 weeks

Secondary

Measure	Time frame
Adverse event assessments	Throughout the study, first instillation to Week 12

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026