Early vs Delayed Intravesical Blad-Care During BCG Therapy

Recruiting now · Not applicable

Conditions studied: Urinary Bladder Neoplasms, BCG-Induced Cystitis

In brief

Intravesical Bacillus Calmette-Guérin (BCG) therapy is the standard adjuvant treatment for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC). However, BCG therapy frequently induces local bladder irritation symptoms including urinary frequency, urgency, dysuria, hematuria, and suprapubic pain, which may reduce quality of life and lead to treatment interruption. Blad-Care™ is an intravesical therapy containing hyaluronic acid and chondroitin sulfate, key components of the urothelial glycosaminoglycan (GAG) layer. Restoration of the GAG layer may protect the bladder mucosa and reduce inflammation-induced bladder irritation symptoms. This prospective randomized study aims to determine whether early administration of intravesical Blad-Care during BCG induction improves BCG-induced bladder toxicity compared with delayed administration after completion of BCG induction therapy.

Key facts

Study ID

NCT07495072

Run by

BLAD-HYA Group

People needed

56

Starts

2025-11-03

Expected to finish

2027-06-01

Last updated by the study team

2026-03-27

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Kyung Hee University Hospital — Seoul, Dongdaemun-gu, South Korea (enrolling)

Full record on ClinicalTrials.gov

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