Real-world Evidence Study on Cystistat

Last updated: August 23, 2024
Sponsor: MEDA Pharma GmbH & Co. KG
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Gynecological Infections

Urinary Incontinence

Bladder Disorders

Treatment

intravesical sodium hyaluronate (Cystistat®)

Clinical Study ID

NCT05544695
CYST-SLZ-7001
  • Ages > 18
  • Female

Study 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.

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

Total Participants: 74
Treatment Group(s): 1
Primary Treatment: intravesical sodium hyaluronate (Cystistat®)
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
March 31, 2025

Study Description

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

Connect with a study center

  • Medical University of Vienna

    Vienna,
    Austria

    Site Not Available

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