Real-world Evidence Study on Cystistat

NCT ID: NCT05544695

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-21
• Study Completion Date: 2024-07-29

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• First prescription of Cystistat according to instructions for use.
• Female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (IC)/bladder pain syndrome (BPS). If in accordance with routine clinical practice at the site, ESSIC diagnostic criteria will be used.
• Age: 18 years and older.
• At least 6 months duration of bladder pain/discomfort symptom(s), e.g. constant bladder pain/discomfort or bladder pain/discomfort when voiding or as a burning sensation between voids as the bladder fills with urine.
• At least one accompanying intermittent or persistent lower urinary tract symptom, such as urinary frequency, urgency, or nocturia during the previous 6 months.
• Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) > 18 prior to first treatment.
• Written informed consent.

Exclusion Criteria

• Known hypersensitivity reactions to sodium hyaluronate.
• Pregnancy / planned pregnancy or breastfeeding during the course of this NIS.
• Known history of any GAG substitution therapy within the last 2 years.
• Known history of fulguration or resection of Hunner's lesions.
• Known diagnosis of recurrent urinary tract infection or overactive bladder.
• Any other conditions or diseases that can cause similar symptoms, using information from medical history, physical examination findings, laboratory studies (e.g., urine bacterial culture), and other previously performed procedures (e.g., urodynamics, cystoscopy, laparoscopy, radiological studies).
• Patients are not able to fulfil study requirements according to physician's opinion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MEDA Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CYST-SLZ-7001

Identifier Type: -

Identifier Source: org_study_id