An all-in-one device managed small recurrent bladder tumours in clinic under local anaesthesia

Design

Prospective open-label single-arm first-in-human study (with preclinical porcine work)

Population

18 adults with recurrent Ta/T1 NMIBC lesions ≤10 mm

Primary outcome

Proportion of histologically evaluable biopsies

Effect

134/145 (92%) evaluable; patient-level yield 89%; no device-related adverse events; median pain 0.5/10

Recurrent non-muscle-invasive bladder cancer often means repeated transurethral resection under anaesthesia. This Swedish first-in-human study tested Multi4, an instrument used through a flexible cystoscope that combines local anaesthetic injection, diathermy biopsy, coagulation and tissue retrieval, in 18 adults with recurrent Ta/T1 lesions of 10 mm or less, after testing in pigs.

Of 145 biopsies, 134 (92%) were histologically evaluable, meeting the primary endpoint; diagnostic yield per patient was 89%. There were no device-related adverse events or complications, no conversions to theatre, and median pain was 0.5 out of 10. Estimated cost per procedure was 73% to 89% lower than transurethral resection.

This is early feasibility work in a small, selected group, and the device is not available in India. The direction — managing small recurrences in clinic — matters for overloaded theatre lists.

• Consider office-based fulguration or biopsy for small, low-grade recurrences where available and appropriate.
• Keep transurethral resection for larger, high-grade or T1 recurrences needing full staging.
• Treat this device as investigational; it is not available in India.
• Maintain cystoscopic surveillance schedules according to risk group.

Why it matters

It points to a way of taking small recurrences out of the operating theatre.

Don't overread it

Eighteen patients in a single-arm feasibility study; oncological outcomes were not measured.

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