IC/BPS: Real-world Evidence Study on Cystistat

Sponsor
MEDA Pharma GmbH & Co. KG (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05544695
Collaborator
(none)
74
15.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: intravesical sodium hyaluronate (Cystistat®)

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
74 participants
Observational Model:
Other
Time Perspective:
Prospective
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).
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Patient Global Assessment (PGA) [End of treatment or latest at week 12]

    Responder rate as indicated by improvement on a seven-point Patient Global Assessment (PGA) scale where the patient is able to evaluate the overall change in her IC/BPS condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse.

Secondary Outcome Measures

  1. Assessment of BPIC-SS [To be completed prior to the first treatment, at end of treatment or latest at week 12, and approximately at month 6.]

    Bladder Pain/ Interstitial Cystitis Symptom Score

  2. Assessment of VAS [To be completed prior to first treatment, at end of treatment or latest at week 12, and at month 6]

    Visual Analogue Scale (VAS) for bladder pain, urinary urgency, and quality of life (QoL)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • MEDA Pharma GmbH & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT05544695
Other Study ID Numbers:
  • CYST-SLZ-7001
First Posted:
Sep 16, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2022