NCT05544695

Real-world Evidence Study on Cystistat

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.

Conditions

• Interstitial Cystitis and Bladder Pain Syndrome

Interventions

Type	Name	Description
DEVICE	intravesical sodium hyaluronate (Cystistat®)	Cystistat will be instilled into the bladder according to the instructions for use and in line with the routine clinical practice.

Timeline

• Start date: 2022-10-21
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2022-09-16
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

1 site across 1 country: Austria