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Optimal Timing of Intravesical GAG Restoration Therapy for BCG-Induced Bladder Toxicity in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Kyung Hee University Hospital
RECRUITING
Seoul
Contact Information
Primary
Chunwoo Lee, M.D., Ph.D.
lcw200@hanmail.net
+8229588897
Backup
Jinsung Park, M.D., Ph.D.
jspark.uro@gmail.com
+8229588896
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 56
Treatments
Experimental: Group A (Early Blad-Care Administration)
Patients receive intravesical BCG once weekly for six weeks. Beginning with the fourth BCG instillation, intravesical Blad-Care is administered immediately after BCG instillation for three consecutive weeks (weeks 4-6).
Active_comparator: Group B (Delayed Blad-Care Administration)
Patients receive intravesical BCG once weekly for six weeks. Blad-Care is administered after completion of the BCG induction course and repeated weekly for three consecutive weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Eulji University
Leads: BLAD-HYA Group

This content was sourced from clinicaltrials.gov