An observational study in Interstitial Cystitis and Bladder Pain Syndrome, sponsored by MEDA Pharma GmbH & Co. KG. Completed at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by MEDA Pharma GmbH & Co. KG (part of Viatris Inc.) · Observational
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.
Real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 74 is below the median of 100 across 63 observational studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →MEDA Pharma GmbH & Co. KG is the lead sponsor of 24 studies on the registry; none are open to participants now.
First submitted after MEDA Pharma GmbH & Co. KG became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
Approximately 74 female patients with IC/BPS will be included in the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cystistat will be instilled into the bladder according to the instructions for use and in line with the routine clinical practice.
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".).
Time frame: Up to week 12
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
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: Up to week 12 and additionally at Month 6
| Milestone | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Started | 73 |
| Completed | 68 |
| Not completed | 5 |
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".).
| percentage of participants (%) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Patient Global Assessment (PGA) | 90.1 (82.28 to 95.28) |
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
| score on a scale (change from baseline) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| End of treatment or latest week 12 | -13.8 ± 8.62 |
| Month 6 | -15.3 ± 9.15 |
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".
| units on a scale (change from baseline) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| End of treatment or latest week 12 | -42.0 ± 27.49 |
| Month 6 | -49.2 ± 29.69 |
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".
| units on a scale (change from baseline) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| End of treatment or latest week 12 | -39.3 ± 28.90 |
| Month 6 | -49.2 ± 30.48 |
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".
| units on a scale (change from baseline) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| End of treatment or latest week 12 | 17.1 ± 35.84 |
| Month 6 | 27.2 ± 33.27 |
Collected over 6 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution | 0/73 (0%) | 1/73 (1.4%) | 13/73 (17.8%) |
| Event | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| pyrexiaGeneral disorders | 1/73 |
| Event | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Condition AgravatedGeneral disorders | 3/73 |
| Urinary Tract InfectionInfections and infestations | 3/73 |
| Catheter Site PainGeneral disorders | 2/73 |
| Abdominal Pain LowerGastrointestinal disorders | 2/73 |
| DiarrhoeaGastrointestinal disorders | 2/73 |
| DysuriaRenal and urinary disorders | 2/73 |
| Renal ColicRenal and urinary disorders | 2/73 |
| Age, Continuous(Years) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Mean | 51.9 ± 17.15 |
| Sex: Female, Male(Participants) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Female | 72 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Ethnicity — Caucasian | 67 |
| Ethnicity — African | 1 |
| Ethnicity — Hispanic | 5 |
| Region of Enrollment(Participants) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Europe | 73 |
| Bladder Pain/ Interstitial Cystitis Symptom Score(score on a scale) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Mean | 29.3 ± 4.58 |
| Visual Analogue Scale (urinary urgency)(units on a scale) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Mean | 75.2 ± 21.70 |
| Visual Analogue Scale (bladder pain)(units on a scale) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Mean | 74.7 ± 18.70 |
| Visual Analogue Scale (quality of life)(units on a scale) | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Mean | 53.1 ± 28.90 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2022 to primary completion in Jul 2024, 21 months.
Results were first posted in Jan 2026, 1 year 5 months after primary completion.
Of 21 observational studies under Cystitis, Interstitial, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 69. This study's 21 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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