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OpenTrials
Completed

NCT Number: NCT05544695

Real-world Evidence Study on Cystistat

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.

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Key information

Conditions

Interstitial Cystitis and Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medical University of Vienna

Vienna, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intravesical sodium hyaluronate (Cystistat®)

Device

Cystistat will be instilled into the bladder according to the instructions for use and in line with the routine clinical practice.

Primary outcomes

  1. Patient Global Assessment (PGA)

    Time frame: Up to week 12

    For the primary analysis, a responder was defined as a participant who had an improvement on the PGA scale (i.e., PGA evaluated as markedly improved, moderately improved, or slightly improved. In case of slightly improved, participants were considered as responder only if the question "Did therapy have a positive effect on your life, and would you undergo this treatment again?" is answered with "Yes".).

Secondary outcomes

  1. Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score

    Time frame: Up to week 12 and additionally at Month 6

    The Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) is a validated questionnaire for the measurement of IC/BPS symptoms. It contains 8 questions and the total score ranges from 0 to 38, with higher scores indicating a worse situation

  2. Assessment of Visual Analogue Scale (VAS) for Bladder Pain

    Time frame: Up to week 12 and additionally at Month 6

    Patients will be asked to assess their bladder pain on the VAS using the question "How was your bladder pain over the last 3 days?". The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = "no pain" and 100 = "worst possible pain".

  3. Assessment of Visual Analogue Scale (VAS) for Urinary Urgency.

    Time frame: Up to week 12 and additionally at Month 6

    Patients will be asked to assess their urinary urgency on the VAS using the question "How intense was urinary urgency over the last 3 days?". The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = "no urgency" and 100 = "worst possible urgency".

  4. Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL)

    Time frame: Up to week 12 and additionally at Month 6

    Patients will be asked to assess QoL on the VAS using the question "How good or bad would you rate your overall health condition throughout the last 3 days?". The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = "the worst health you can imagine" and 100 = "the best health you can imagine".

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study 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)

Acronym: IC/BPS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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