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NCT07495072Recruiting

Early vs Delayed Intravesical Blad-Care During BCG Therapy

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
56 (estimated)
First submitted
13 Mar 2026
Start date
Nov 2025
Primary completion date
Dec 2026
Lead sponsor
BLAD-HYA Group
NCT number
NCT07495072

What you commit to

  • Study type: Interventional
  • Planned participants: 56
  • From Nov 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to BCG therapy

Other illness

  • Hypersensitivity to components of Blad-Care
  • Any condition considered unsuitable for study participation by the investigator

Other

  • Neurogenic bladder or significant urinary tract abnormalities
  • Severe renal dysfunction

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kyung Hee University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.