N/A
N=53
URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
Painful Bladder Syndrome · Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT00150488 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Percentage of Responders to Treatment — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Uracyst (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dr. J. Curtis Nickel
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders to Treatment |
25 | — |
| SECONDARY Change in Likert Pain Score From Baseline at 10 Weeks |
-2.6 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00150488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.