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Early vs Delayed Intravesical Blad-Care During BCG Therapy

NCT07495072 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-27

No results posted yet for this study

Summary

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

  • Urinary Bladder Neoplasms
  • BCG-Induced Cystitis

Interventions

DRUG

Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)

Intravesical instillation of a sterile solution containing sodium hyaluronate and chondroitin sulfate designed to restore the urothelial glycosaminoglycan (GAG) layer.

Sponsors & Collaborators

  • Eulji University

    collaborator OTHER

  • BLAD-HYA Group

    lead OTHER

Principal Investigators

  • Chunwoo Lee · Kyung Hee University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07495072 on ClinicalTrials.gov