CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
intravesical sodium hyaluronate (Cystistat®)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05544695
NCT05544695N/ACompleted
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Real-world Evidence Observational Study to Evaluate Performance and Safety of Intravesical Sodium Hyaluronate (Cystistat®) in the Treatment of Patients With Interstitial Cystitis (IC) / Bladder Pain Syndrome (BPS)

MEDA Pharma GmbH & Co. KG·observational·Posted Sep 16, 2022·Updated Jan 9, 2026

In Brief

An observational study evaluating intravesical sodium hyaluronate (Cystistat®) for Interstitial Cystitis and Bladder Pain Syndrome. Completed, enrolled 74 participants across 1 site.

Detailed Summary

This study will be conducted with the aim of ensuring the continued acceptability of the benefit-risk ratio and confirming the safety and performance of the device throughout its expected lifetime. Cystistat is supplied as a 50 mL solution containing 40 mg of sodium hyaluronate. It is indicated for the temporary replacement of the GAG layer in the bladder.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInterstitial Cystitis and Bladder Pain Syndrome
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 16, 2022
Enrollment StartOct 21, 2022
Primary CompletionJul 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.8 years ago

Interventions

intravesical sodium hyaluronate (Cystistat®)device

Cystistat will be instilled into the bladder according to the instructions for use and in line with the routine clinical practice.