Early vs Delayed Intravesical Blad-Care During BCG Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorBLAD-HYA Group

About this trial

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 criteria

Qualifiers

Adults aged ≥19 years

Histologically confirmed non-muscle-invasive bladder cancer

Candidates for intravesical BCG therapy

Negative urine culture prior to BCG therapy

Disqualifiers

Hypersensitivity to components of Blad-Care

Contraindication to BCG therapy

Neurogenic bladder or significant urinary tract abnormalities

Severe renal dysfunction

Trial design

Treatments tested in this trial

  • Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)

Treatment groups

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators

BLAD-HYA Group

Lead sponsor

Kyung Hee University Hospital

Sponsor institution

Eulji University

Collaborator