IC/BPS: Real-world Evidence Study on Cystistat
Study Details
Study Description
Brief 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. It is indicated for the temporary replacement of the GAG layer in the bladder.
Condition or Disease | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- Patient Global Assessment (PGA) [End of treatment or latest at week 12]
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.
Secondary Outcome Measures
- Assessment of BPIC-SS [To be completed prior to the first treatment, at end of treatment or latest at week 12, and approximately at month 6.]
Bladder Pain/ Interstitial Cystitis Symptom Score
- Assessment of VAS [To be completed prior to first treatment, at end of treatment or latest at week 12, and at month 6]
Visual Analogue Scale (VAS) for bladder pain, urinary urgency, and quality of life (QoL)
Eligibility Criteria
Criteria
Inclusion Criteria:
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First prescription of Cystistat according to instructions for use.
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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.
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Age: 18 years and older.
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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.
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At least one accompanying intermittent or persistent lower urinary tract symptom, such as urinary frequency, urgency, or nocturia during the previous 6 months.
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Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) > 18 prior to first treatment.
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Written informed consent.
Exclusion Criteria:
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Known hypersensitivity reactions to sodium hyaluronate.
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Pregnancy / planned pregnancy or breastfeeding during the course of this NIS.
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Known history of any GAG substitution therapy within the last 2 years.
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Known history of fulguration or resection of Hunner's lesions.
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Known diagnosis of recurrent urinary tract infection or overactive bladder.
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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).
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Patients are not able to fulfil study requirements according to physician's opinion.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- MEDA Pharma GmbH & Co. KG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CYST-SLZ-7001