Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT07495072

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, South Korea, 02447

Actively Recruiting

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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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