NCT07125924

Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer

Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy and safety of intravesical hyaluronic acid (HA) instillation therapy for the prevention of radiation-induced cystitis in patients undergoing radiotherapy for bladder cancer.

Detailed description

Study Design: Single-blind, Randomized, Controlled trial. * Primary endpoint \- To assess patient-reported outcomes (PROs) related to symptoms of radiation-induced cystitis in patients with bladder cancer undergoing radiotherapy. * Secondary endpoint * To evaluate tumor control rates in patients with bladder cancer undergoing radiotherapy. * To assess the incidence and severity of radiation-induced cystitis using RTOG/EORTC criteria, CTCAE grading, and cystoscopic findings. * To compare healthcare costs between the treatment group receiving intravesical hyaluronic acid instillation and the control group.

Conditions

• Bladder Cancer
• Radiation Cystitis

Interventions

Type	Name	Description
DEVICE	Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.)	Bladder instillation of Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) will be administered aseptically once weekly for a total of five times following each session of radiotherapy.
OTHER	Normal Saline (NS)	Normal saline will be instilled into the bladder following the same schedule as the intervention group, i.e., five times after each radiotherapy session.

Timeline

• Start date: 2025-08-22
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: South Korea