Real-world Evidence Study on Cystistat

NCT05544695 | Completed Results

• 1 other identifier: CYST-SLZ-7001
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis and Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Patient Global Assessment (PGA)

  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".).

  Up to week 12

Secondary Outcomes (4)

• Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score

  Up to week 12 and additionally at Month 6

• Assessment of Visual Analogue Scale (VAS) for Bladder Pain

  Up to week 12 and additionally at Month 6

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

  Up to week 12 and additionally at Month 6

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

  Up to week 12 and additionally at Month 6

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (IC)/bladder pain syndrome (BPS).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 74 female patients with IC/BPS will be included in the study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Christine Kolb
• Organization: MEDA Pharma GmbH & Co. KG (A Viatris Company)

christine.kolb@viatris.com

+49 6172 888

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: October 21, 2022
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: January 9, 2026
• Results First Posted: January 9, 2026

Record last verified: 2025-11

Locations

AU (1)