URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

Not Applicable

Completed

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:

1. 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.

2. 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.

3. 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	Uracyst	Uracyst® single arm open label Treatment Group

Primary Outcome Measures

Name	Time	Method
Percentage of Responders to Treatment	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

Secondary Outcome Measures

Name	Time	Method
Change in Likert Pain Score From Baseline at 10 Weeks	Baseline and 10 Weeks	Scale of 0-10; subjects report 0=no pain and 10 pain as bad as you can imagine.