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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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".). | Up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to week 12 and additionally at Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
Female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (IC)/bladder pain syndrome (BPS).
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Approximately 74 female patients with IC/BPS will be included in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria |
One patient did not receive study treatment due to withdrawal of consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Cystistat® 40 mg/50 mL Solution | All participants received treatment per standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Cystistat® 40 mg/50 mL Solution | All participants received treatment per standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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".). | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants (%) | Up to week 12 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: Cystistat® 40 mg/50 mL Solution | Per standard of care | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pyrexia | General disorders | Systematic Assessment | non-related SAE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter Site Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Kolb | MEDA Pharma GmbH & Co. KG (A Viatris Company) | +49 6172 888 | 2511 | christine.kolb@viatris.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2022 | Sep 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2023 | Sep 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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". | 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". | 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". | Up to week 12 and additionally at Month 6 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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. | Full analysis set | Mean | Standard Deviation | score on a scale |
|
| Visual Analogue Scale (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". | Full analysis set | Mean | Standard Deviation | units on a scale |
|
| Visual Analogue Scale (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". | Full analysis set | Mean | Standard Deviation | units on a scale |
|
| Visual Analogue Scale (quality of life) | 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". | Full analysis set | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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 | Full analysis set | Posted | Mean | Standard Deviation | score on a scale (change from baseline) | Up to week 12 and additionally at Month 6 |
|
|
|
| Secondary | 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". | Full analysis set | Posted | Mean | Standard Deviation | units on a scale (change from baseline) | Up to week 12 and additionally at Month 6 |
|
|
|
| Secondary | 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". | Full analysis set | Posted | Mean | Standard Deviation | units on a scale (change from baseline) | Up to week 12 and additionally at Month 6 |
|
|
|
| Secondary | 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". | Full anaylsis set | Posted | Mean | Standard Deviation | units on a scale (change from baseline) | Up to week 12 and additionally at Month 6 |
|
|
|
| 73 |
| 1 |
| 73 |
| 13 |
| 73 |
| Abdominal Pain Lower | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Condition Agravated | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |