Real-world Evidence Study on Cystistat

Study Overview
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Brief Summary
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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.

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

Official Title
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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)

Conditions
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Interstitial Cystitis and Bladder Pain Syndrome

Intervention / Treatment
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* Device: intravesical sodium hyaluronate (Cystistat®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment (PGA) | Responder rate as indicated by improvement on a seven-point Patient Global Assessment (PGA) scale where the patient is able to evaluate the overall change in her IC/BPS condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse. | Up to week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |