Clinical trial NCT05544695: Real-world Evidence Study on Cystistat
Official title: Real-world Evidence Observational Study to Evaluate Performance and Safety of Intravesical Sodium Hyaluronate (Cystistat®) in the Treatment of Patients With Interstitial Cystitis (IC) / Bladder Pain Syndrome (BPS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Interstitial Cystitis and Bladder Pain Syndrome
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 74 female patients with IC/BPS will be included in the study

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.

Detailed description: Real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.

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.

Primary outcomes:
measure: Patient Global Assessment (PGA)
timeFrame: Up to week 12
Secondary outcomes:
measure: Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score
timeFrame: Up to week 12 and additionally at Month 6
measure: Assessment of Visual Analogue Scale (VAS) for bladder pain
timeFrame: Up to week 12 and additionally at Month 6
measure: Assessment of Visual Analogue Scale (VAS) for urinary urgency.
timeFrame: Up to week 12 and additionally at Month 6
measure: Assessment of Visual Analogue Scale (VAS) for quality of life (QoL)
timeFrame: Up to week 12 and additionally at Month 6
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: