Interstitial Cystitis and Bladder Pain SyndromeIC/BPSNCT05544695

Real-world Evidence Study on Cystistat

An observational study of Interstitial Cystitis and Bladder Pain Syndrome, run by MEDA Pharma GmbH & Co. KG at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Interstitial Cystitis and Bladder Pain Syndrome
What is being tested?: intravesical sodium hyaluronate (Cystistat®)
Type of treatment: Medical device
How many people: 74 participants
Where: 1 siteAustria
Study dates: 21 Oct 2022to 29 Jul 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna

Other trials in Austria

About this study

Official title: 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)

Read the 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
Being tested: intravesical sodium hyaluronate (Cystistat®)
Medical subject headings: Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Global Assessment (PGA)
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".).
Measured: Up to week 12

Secondary outcomes (4)

Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score
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
Measured: Up to week 12 and additionally at Month 6
Assessment of Visual Analogue Scale (VAS) for Bladder Pain
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".
Measured: Up to week 12 and additionally at Month 6
Assessment of Visual Analogue Scale (VAS) for Urinary Urgency.
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".
Measured: Up to week 12 and additionally at Month 6
Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL)
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".
Measured: Up to week 12 and additionally at Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202229 Jul 2024

First posted16 Sep 2022
Study start21 Oct 2022
Primary completion29 Jul 2024
Study completion29 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Interstitial Cystitis and Bladder Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05544695
Sponsor's protocol ID: CYST-SLZ-7001
Acronym: IC/BPS
Status last verified: Nov 2025
First submitted: 13 Sep 2022
Last updated: 9 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
Not yet recruitingPhase 1
Mirogabalin Plus EBMP for IC/BPS
Bladder Pain Syndrome, Educational Behavioral Intervention

All Interstitial Cystitis and Bladder Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05544695
Acronym / sponsor ID: IC/BPS / CYST-SLZ-7001
Conditions: Interstitial Cystitis and Bladder Pain Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
Study start: 21 Oct 2022 (actual)
Primary completion: 29 Jul 2024 (actual)
Study completion: 29 Jul 2024 (actual)
First posted: 16 Sep 2022 (actual)
Results: Posted 9 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Approximately 74 female patients with IC/BPS will be included in the study

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	–

Primary outcome

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".).

4 secondary outcomes

Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score
Time frame: 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
Assessment of Visual Analogue Scale (VAS) for Urinary Urgency.
Time frame: 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

Results and safety

Results posted to the registry on 9 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm: Cystistat® 40 mg/50 mL Solution	73	68

Primary outcome: Patient Global Assessment (PGA)

Time frame: Up to week 12. Number (90% Confidence Interval). Unit: percentage of participants (%)

Measure	Single Arm: Cystistat® 40 mg/50 mL Solution n = 71
Value	90.1 (82.28 to 95.28)

Population analysed: Full analysis set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm: Cystistat® 40 mg/50 mL Solution	1 of 73 (1.4%)	13 of 73 (17.8%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Interstitial Cystitis and Bladder Pain Syndrome

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
Not yet recruitingPhase 1
Mirogabalin Plus EBMP for IC/BPS
Bladder Pain Syndrome, Educational Behavioral Intervention

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Cystitis and Bladder Pain Syndrome, run by MEDA Pharma GmbH & Co. KG at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Global Assessment (PGA) (time frame: Up to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05544695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.