Real-world Evidence Study on Cystistat (IC/BPS)

December 17, 2025 updated by: MEDA Pharma GmbH & Co. KG

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)

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 Overview

Status

Completed

Conditions

Interstitial Cystitis and Bladder Pain Syndrome

Intervention / Treatment

Device: intravesical sodium hyaluronate (Cystistat®)

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Vienna, Austria
    - Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Approximately 74 female patients with IC/BPS will be included in the study

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Assessment (PGA) Time Frame: Up to week 12	For the primary analysis, a responder was defined as a participant who had an improvement on the PGA scale (i.e., PGA evaluated as markedly improved, moderately improved, or slightly improved. In case of slightly improved, participants were considered as responder only if the question "Did therapy have a positive effect on your life, and would you undergo this treatment again?" is answered with "Yes".).	Up to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score Time Frame: Up to week 12 and additionally at Month 6	The Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) is a validated questionnaire for the measurement of IC/BPS symptoms. It contains 8 questions and the total score ranges from 0 to 38, with higher scores indicating a worse situation	Up to week 12 and additionally at Month 6
Assessment of Visual Analogue Scale (VAS) for Bladder Pain Time Frame: Up to week 12 and additionally at Month 6	Patients will be asked to assess their bladder pain on the VAS using the question "How was your bladder pain over the last 3 days?". The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = "no pain" and 100 = "worst possible pain".	Up to week 12 and additionally at Month 6
Assessment of Visual Analogue Scale (VAS) for Urinary Urgency. Time Frame: Up to week 12 and additionally at Month 6	Patients will be asked to assess their urinary urgency on the VAS using the question "How intense was urinary urgency over the last 3 days?". The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = "no urgency" and 100 = "worst possible urgency".	Up to week 12 and additionally at Month 6
Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL) Time Frame: Up to week 12 and additionally at Month 6	Patients will be asked to assess QoL on the VAS using the question "How good or bad would you rate your overall health condition throughout the last 3 days?". The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = "the worst health you can imagine" and 100 = "the best health you can imagine".	Up to week 12 and additionally at Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEDA Pharma GmbH & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2022

Primary Completion (Actual)

July 29, 2024

Study Completion (Actual)

July 29, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria