Early vs Delayed Intravesical Blad-Care During BCG Therapy

NCT07495072 | Recruiting

• 2 other identifiers: EMC-KHMC-URO-2025KHUH 2025-11-064-002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyaluronic Acid; BCG-induced Cystitis; BCG-related Bladder Pain; Non-Muscle Invasive Bladder Cancer (NMIBC); Interstitial Cystitis

Outcome Measures

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.

  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 (6)

• Change from Baseline in Visual Analogue Scale (VAS) Score for Suprapubic Pain

  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).

• Incidence and Severity of Hematuria

  From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).

• BCG Treatment Completion Rate

  From the date of the first BCG instillation (Week 1) through the date of the sixth BCG instillation (Week 6).

• Incidence of Initiation of Additional Medications for Lower Urinary Tract Symptoms (LUTS)

  From the first BCG instillation (Week 1) through 2 months after completion of BCG therapy (Week 14).

Study Arms (2)

Group A (Early Blad-Care Administration)

EXPERIMENTAL

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).

Drug: Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)

Group B (Delayed Blad-Care Administration)

ACTIVE COMPARATOR

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.

Drug: Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)

Interventions

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

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

Also known as: Sodium Hyaluronate and Chondroitin Sulfate, Blad-Care, HA-CS combination, GAG layer replenisher

Group A (Early Blad-Care Administration); Group B (Delayed Blad-Care Administration)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hypersensitivity to components of Blad-Care
• Contraindication to BCG therapy
• Neurogenic bladder or significant urinary tract abnormalities
• Severe renal dysfunction
• Any condition considered unsuitable for study participation by the investigator

Sponsors & Collaborators

• BLAD-HYA Group: lead
• Eulji University: collaborator

Study Sites (1)

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, 02447, South Korea

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Cystitis, Interstitial

Interventions

Hyaluronic Acid; Chondroitin Sulfates; chondroitin sulfate, sodium hyaluronate drug combination

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Cystitis

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Chondroitin

Study Officials

• Chunwoo Lee

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunwoo Lee, M.D., Ph.D.

CONTACT

+8229588897; lcw200@hanmail.net

Jinsung Park, M.D., Ph.D.

CONTACT

+8229588896; jspark.uro@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study where both investigators and participants are aware of the assigned administration schedule due to the nature of the sequential vs. concurrent treatment timing.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Department of Urology

Model Details: This is a multicenter, prospective, randomized, open-label study to determine the optimal intravesical instillation schedule of Blad-Care™ for alleviating BCG-induced local side effects in patients with non-muscle invasive bladder cancer (NMIBC). Participants are randomized 1:1 into two parallel groups: Group A (Early Blad-Care Administration): Participants receive 6 weekly BCG instillations. For the final 3 weeks (Weeks 4-6), Blad-Care™ is administered immediately after each BCG dose. Group B (Delayed Blad-Care Administration): Participants receive 6 weekly BCG instillations alone. Following the BCG course, Blad-Care™ is administered once a week for 3 consecutive weeks (Weeks 7-9). The primary goal is to compare the symptom relief efficacy of these two schedules using the sum of ICSI and ICPI scores. Assessments are conducted at four time points: baseline, after the 3rd BCG, after the 6th BCG, and 2 months post-BCG therapy.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 27, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)