Tests bladder rinse to prevent radiation-related bladder inflammation in bladder cancer
Tests a hyaluronic acid bladder instillation against saline in adults having radiotherapy for bladder cancer.
Plain-language title generated from the registry record
Registry title: Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
Key facts
- Where
- Goyang-si, South KoreaSee the site
Where in South Korea
- National Cancer Center - KoreaGoyang-si, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Center, Korea
- Trial code
- NCT07125924
- Record updated
- 15 August 2025
- Original description
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.Read full original descriptionShow less
Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial
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.
Inclusion: Pathologic confirmed Muscle-Invasive Urothelial Carcinoma I. Clinical stage: T2-T4a MIBC II. No or limited nodal involvement (N0 or partial N1, only isolated or regional) III. No distant metastasis (M0) IV. Transurethral resection of bladder tumor (TURBT): Maximal TURBT is available > Most tumors must be resected, and residual disease should be minimized; Preserved bladder function is required: patients must have normal bladder capacity and maintain adequate voiding function; Unifocal or localized tumor (except multifocal) VII. No extensive carcinoma in situ (CIS); Age ≥ 19; Karnofsky performance score (KPS) ≥ 70 or ECOG performance status 0~2; Patients who are candidates for bladder-preserving therapy, specifically those scheduled to undergo concurrent chemoradiotherapy (CCRT) instead of radical cystectomy; Patients scheduled to receive radiotherapy in combination with one or more of the following chemotherapeutic agents prior to study enrollment: Cisplatin-based chemotherapy (e.g. weekly cisplatin), Gemcitabine or 5-FU/mitomycin, in accordance with standard clinical practice; Written informed consent obtained from the patients prior to study participation.
Exclusion: Medically inoperable status or poor general condition (ECOG performance status > 2); History of active cystitis or recurrent urinary tract infections within the past 6 months; Known hypersensitivity to hyaluronic acid or related compounds; Any condition in which, in the investigator's judgment, administration of the study drug or procedure is deemed inappropriate; Present of distant metastasis (M1); Tumor invasion beyond the bladder wall into adjacent organs (T4b); Non-urothelial carcinoma (including histologic variant) or predominant of non-urothelial components in mixed histology; Pregnant or breastfeeding women, or women of childbearing potential who are unable or unwilling to use adequate contraception during the study period.