Cystoscopic RADA16 (PuraStat) for Persistent Severe Haematuria Secondary to Radiation Cystitis: A Prospective Two-centre Study

Background and Objective Haemorrhagic radiation cystitis is a challenging complication of pelvic radiotherapy, with limited high-quality evidence to guide management and no established standard of care. We evaluated the real-world efficacy and safety of intravesical RADA16 (PuraStat) for the treatment of persistent severe haematuria secondary to radiation cystitis. Methods This prospective observational study included patients with clinically significant haematuria following radiotherapy, treated with intravesical RADA16 across two NHS Trusts. The primary outcome was resolution of visible haematuria. Secondary outcomes included healthcare utilisation (hospital admissions, length of stay, emergency department attendances) and safety. Patients were followed for a minimum of 90 days. Key Findings and Limitations Ten patients (mean age 79.6 yr; 90% male) were included. Nine of ten patients had complete resolution of macroscopic haematuria during follow-up. One patient reported minimal, self-limiting haematuria occurring intermittently. No procedure-related adverse events were observed. Unplanned healthcare utilisation was reduced to zero in all patients following treatment. Follow-up cystoscopic assessment suggested improvement in bladder lesions. Limitations include the small sample size, single-arm design, and limited follow-up in some patients. Conclusions and Clinical Implications Intravesical RADA16 appears to be a safe and feasible treatment for haemorrhagic radiation cystitis and was associated with resolution of haematuria in the majority of patients and elimination of unplanned hospital attendances. These findings support further evaluation in larger, controlled studies to confirm efficacy, durability, and optimal treatment protocols. Patient Summary: We observed patients undergoing a new treatment for bleeding in the bladder that can occur after radiotherapy. Most patients stopped having visible bleeding after treatment, and none needed to return to hospital unexpectedly. This treatment may offer a simple and safe alternative to more invasive procedures, but larger studies are needed to confirm these results.