Early versus delayed Blad‑Care (hyaluronic acid + chondroitin) during BCG therapy
Official title: Optimal Timing of Intravesical GAG Restoration Therapy for BCG-Induced Bladder Toxicity in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Randomized Study
Run by BLAD-HYA Group · NCT07495072 · Data updated 2026-11-12
This trial will test whether giving Blad‑Care (hyaluronic acid and chondroitin sulfate) early during BCG treatment reduces bladder irritation in adults with non‑muscle‑invasive bladder cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | BLAD-HYA Group Academic / other |
| Locations | 1 site (Seoul, Dongdaemun-gu) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07495072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥19 years) with histologically confirmed non‑muscle‑invasive bladder cancer who are candidates for intravesical BCG, have a negative urine culture, and can provide written informed consent.
✕Probably not a fit
Patients with hypersensitivity to Blad‑Care components, contraindications to BCG, neurogenic bladder or major urinary tract abnormalities, severe renal dysfunction, or other investigator‑determined exclusions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with non‑muscle‑invasive bladder cancer receiving intravesical BCG are randomized to receive intravesical Blad‑Care either early during BCG induction or delayed after induction. Blad‑Care contains hyaluronic acid and chondroitin sulfate intended to restore the bladder glycosaminoglycan (GAG) layer and protect the urothelium. The study prospectively compares bladder irritation symptoms, adverse events, and BCG treatment adherence between the two timing strategies. The multicenter trial at Korean sites seeks to identify whether early administration reduces BCG‑induced cystitis without compromising oncologic therapy.
Why it matters
Potential benefit: If successful, early Blad‑Care could reduce BCG‑related urinary pain and urgency, improve quality of life, and help patients complete their BCG treatment.
How similar studies have gone: Previous small studies of GAG‑replacement therapies have shown symptom improvement in chemical cystitis, but evidence for benefit specifically during BCG therapy is limited and the optimal timing is unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥19 years * Histologically confirmed non-muscle-invasive bladder cancer * Candidates for intravesical BCG therapy * Negative urine culture prior to BCG therapy * Ability to provide written informed consent Exclusion Criteria: * Hypersensitivity to components of Blad-Care * Contraindication to BCG therapy * Neurogenic bladder or significant urinary tract abnormalities * Severe renal dysfunction * Any condition considered unsuitable for study participation by the investigator
Where it's running
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Kyung Hee University Hospital
Seoul, Dongdaemun-gu, South Korea Recruiting
Study contacts
- Principal investigator: Chunwoo Lee — Kyung Hee University Hospital
- Study coordinator: Chunwoo Lee, M.D., Ph.D.
- Email: lcw200@hanmail.net
- Phone: +8229588897
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.