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URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

Primary Purpose

Painful Bladder Syndrome, Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Uracyst
Sponsored by
Dr. J. Curtis Nickel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Bladder Syndrome focused on measuring PBS, Painful Bladder Syndrome, Interstitial Cystitis, chrondroitin sulfate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 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

Sites / Locations

  • Centre for Advanced Urological Research, Kingston General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Uracyst® single arm open label Treatment Group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 6, 2005
Last Updated
September 12, 2022
Sponsor
Dr. J. Curtis Nickel
Collaborators
Stellar Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00150488
Brief Title
URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
Official Title
URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. J. Curtis Nickel
Collaborators
Stellar Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Bladder Syndrome, Interstitial Cystitis
Keywords
PBS, Painful Bladder Syndrome, Interstitial Cystitis, chrondroitin sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Uracyst
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Uracyst® single arm open label Treatment Group
Intervention Type
Device
Intervention Name(s)
Uracyst
Other Intervention Name(s)
chondroitin sulphate
Intervention Description
2% weekly for 6 weeks, monthly for 4 months
Primary Outcome Measure Information:
Title
Percentage of Responders to Treatment
Description
indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline
Time Frame
Week 10 (4 weeks after the initial six treatments
Secondary Outcome Measure Information:
Title
Change in Likert Pain Score From Baseline at 10 Weeks
Description
Scale of 0-10; subjects report 0=no pain and 10 pain as bad as you can imagine.
Time Frame
Baseline and 10 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Nickel, MD FRCSC
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Advanced Urological Research, Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

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URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

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