Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT05544695
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05544695
Study Brief:
Protocol Section:
NCT05544695