Phase
Condition
Gynecological Infections
Urinary Incontinence
Bladder Disorders
Treatment
intravesical sodium hyaluronate (Cystistat®)
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
First prescription of Cystistat according to instructions for use.
Female patients of any ethnic origin with clinical diagnosis of interstitialcystitis (IC)/bladder pain syndrome (BPS). If in accordance with routine clinicalpractice 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. constantbladder pain/discomfort or bladder pain/discomfort when voiding or as a burningsensation 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 firsttreatment.
Written informed consent.
Exclusion
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 informationfrom medical history, physical examination findings, laboratory studies (e.g., urinebacterial 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.
Study Design
Study Description
Connect with a study center
Medical University of Vienna
Vienna,
AustriaSite Not Available
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