Actively Recruiting
Early vs Delayed Intravesical Blad-Care During BCG Therapy
Led by BLAD-HYA Group · Updated on 2026-03-27
56
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
B
BLAD-HYA Group
Lead Sponsor
E
Eulji University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early vs Delayed Intravesical Blad-Care During BCG Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 6519 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, South Korea, 02447
Actively Recruiting
Research Team
C
Chunwoo Lee, M.D., Ph.D.
CONTACT
J
Jinsung Park, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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