The role of PuraStat ^® in radiation-induced haematuria: A novel approach? A scoping review of clinical evidence

Background: Radiation-induced haemorrhagic cystitis (RIHC) is a challenging complication of pelvic radiotherapy, characterised by refractory haematuria and limited effective treatments. PuraStat, a self-assembling peptide hydrogel with haemostatic properties, has shown efficacy in managing gastrointestinal bleeding, including radiation proctopathy. This scoping review evaluates its potential as a novel therapy for RIHC. Objective: To map and evaluate existing clinical evidence on the use of PuraStat in managing radiation-induced haematuria. Methods: A scoping review was conducted using the PRISMA-ScR framework. Literature was searched for studies on PuraStat in RIHC, radiation proctopathy, or analogous bleeding conditions, supplemented by mechanistic evidence, these studies were screened and data from relevant studies collated and analysed. Results: Direct evidence for PuraStat in RIHC is limited, but studies in radiation proctopathy demonstrate reduced bleeding and improved clinical outcomes. Its mechanism – forming a haemostatic mesh upon blood contact – suggests applicability to bladder mucosa. Observational data and ongoing trials indicate promise, though randomised controlled trials (RCTs) are lacking. Conclusion: PuraStat offers a promising, minimally invasive option for RIHC. Further research, including RCTs, is needed to confirm efficacy, safety, and optimal administration protocols.