Real-world Evidence Study on Cystistat

Launched by MEDA PHARMA GMBH & CO. KG · Sep 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Cystistat for women with interstitial cystitis (IC) or bladder pain syndrome (BPS). Cystistat is a special solution that helps temporarily restore a protective layer in the bladder, which can get damaged and lead to pain and discomfort. The trial aims to confirm that Cystistat is safe and effective for patients over time.

To participate in this study, you must be a woman aged 18 or older who has been diagnosed with IC or BPS and has experienced bladder pain or discomfort for at least six months. You’ll need to have specific symptoms, like frequent urination or urgency, and you must be giving your written consent to join. However, some people won't qualify, such as those who are pregnant or breastfeeding, have had certain bladder surgeries recently, or have other conditions that could cause similar symptoms. If you decide to participate, you’ll be monitored to ensure that the treatment remains safe and beneficial for you throughout the study.

Gender

FEMALE

Eligibility criteria

• 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.