Real-world Evidence Study on Cystistat

Active, not recruiting

• Conditions: Interstitial Cystitis and Bladder Pain Syndrome

• Registration Number: NCT05544695
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-9-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - First prescription of Cystistat according to instructions for use.<br><br> - Female patients of any ethnic origin with clinical diagnosis of interstitial<br> cystitis (IC)/bladder pain syndrome (BPS). If in accordance with routine clinical<br> practice at the site, ESSIC diagnostic criteria will be used.<br><br> - Age: 18 years and older.<br><br> - At least 6 months duration of bladder pain/discomfort symptom(s), e.g. constant<br> bladder pain/discomfort or bladder pain/discomfort when voiding or as a burning<br> sensation between voids as the bladder fills with urine.<br><br> - At least one accompanying intermittent or persistent lower urinary tract symptom,<br> such as urinary frequency, urgency, or nocturia during the previous 6 months.<br><br> - Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) > 18 prior to first<br> treatment.<br><br> - Written informed consent.<br><br>Exclusion Criteria:<br><br> - Known hypersensitivity reactions to sodium hyaluronate.<br><br> - Pregnancy / planned pregnancy or breastfeeding during the course of this NIS.<br><br> - Known history of any GAG substitution therapy within the last 2 years.<br><br> - Known history of fulguration or resection of Hunner's lesions.<br><br> - Known diagnosis of recurrent urinary tract infection or overactive bladder.<br><br> - Any other conditions or diseases that can cause similar symptoms, using information<br> from medical history, physical examination findings, laboratory studies (e.g., urine<br> bacterial culture), and other previously performed procedures (e.g., urodynamics,<br> cystoscopy, laparoscopy, radiological studies).<br><br> - Patients are not able to fulfil study requirements according to physician's opinion.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Global Assessment (PGA)

Secondary Outcome Measures

Name	Time	Method
Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score;Assessment of Visual Analogue Scale (VAS) for bladder pain;Assessment of Visual Analogue Scale (VAS) for urinary urgency.;Assessment of Visual Analogue Scale (VAS) for quality of life (QoL)