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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)
DrugIntravesical instillation of a sterile solution containing sodium hyaluronate and chondroitin sulfate designed to restore the urothelial glycosaminoglycan (GAG) layer.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Group A (Early Blad-Care Administration)Experimental treatment 1 intervention
Group B: Group B (Delayed Blad-Care Administration)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the combined Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI) score
The ICSI and ICPI are validated scales to assess bladder symptoms and related problems. The combined score ranges from 0 to 31, where higher scores indicate worse symptoms and greater impact on quality of life.
Time frame
Baseline (Week 0), after 3rd BCG instillation (Week 3), after 6th BCG instillation (Week 6), and 2 months after completion of BCG therapy (Week 14).Secondary outcomes
1
Change from Baseline in Visual Analogue Scale (VAS) Score for Suprapubic Pain
The Visual Analogue Scale (VAS) is used to measure the intensity of suprapubic pain experienced by the patient. It consists of a 10 cm (or 100 mm) horizontal line, where the left end represents "no pain" (score of 0) and the right end represents "worst imaginable pain" (score of 10). Patients mark a point on the line that corresponds to their pain level. Higher scores indicate greater pain intensity. The study evaluates the reduction in pain levels by comparing the mean change in VAS scores between the two groups (Group A vs. Group B) at each follow-up point compared to the baseline.
Time frame
Baseline (Week 0), after 3rd BCG instillation (Week 3), after 6th BCG instillation (Week 6), and 2 months after completion of BCG therapy (Week 14).2
Incidence and Severity of Hematuria
Hematuria severity is assessed using a graded scale to evaluate the safety and local side effects of BCG and Blad-Care™ therapy. Hematuria will be graded according to CTCAE version 5.0.
Time frame
From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).3
Incidence of Treatment-Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of Blad-Care™ when administered concurrently with or sequentially after BCG therapy. Adverse events include, but are not limited to, bladder irritation, urinary tract infection, severe hematuria, and systemic BCG infection. All adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence and severity of these events will be compared between Group A and Group B.
Time frame
From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).4
BCG Treatment Completion Rate
The BCG completion rate is defined as the percentage of participants who successfully receive all six planned weekly intravesical instillations of BCG therapy. A "completed" treatment is defined as receiving the full dose of BCG without permanent discontinuation due to treatment-related adverse events, disease progression, or patient withdrawal. This measure evaluates the tolerability of the combined treatment (Group A) compared to the sequential treatment (Group B). A higher rate indicates better clinical compliance and tolerability of the assigned regimen.
Time frame
From the date of the first BCG instillation (Week 1) through the date of the sixth BCG instillation (Week 6).Sponsors and contacts
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BLAD-HYA Group
Lead sponsor
Kyung Hee University Hospital
Sponsor institution
Eulji University
Collaborator
Source ClinicalTrials.gov