Cystoscopic RADA16 (PuraStat) for persistent severe haematuria secondary to radiation cystitis: an exploratory prospective two-centre study.

BACKGROUND AND

objectiveHaemorrhagic radiation cystitis is a challenging complication of pelvic radiotherapy, with limited high-quality evidence to guide management and no established standard of care. We explored the real-world potential and safety of intravesical RADA16 (PuraStat) for the treatment of persistent severe haematuria secondary to radiation cystitis.

methodsThis exploratory prospective observational study included consecutive 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 consecutive patients (mean age 79.6 yr; 90% male) were included. Nine of the ten patients had complete resolution of visible haematuria during follow-up. One patient reported minimal, self-limiting haematuria occurring intermittently, which had subsided by the one-year follow-up. 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 shows potential in relation to safety and feasibility for the treatment of haemorrhagic radiation cystitis. In the present exploratory study RADA16 was associated with resolution of haematuria in the majority of patients and elimination of unplanned hospital attendances although these findings must be interpreted with caution owing to the small sample size, short and variable follow-up, and lack of control group. However, these findings support further evaluation in larger, controlled studies to confirm efficacy, durability, and optimal treatment protocols. 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.