ArticleBJU international2026
First-in-human outpatient management of recurrent NMIBC with the Multi4 instrument.
Article in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectivesTo evaluate the feasibility, safety and diagnostic performance of outpatient management of recurrent non-muscle-invasive bladder cancer (NMIBC) under local anaesthesia using the Multi4 instrument, a series of preclinical studies were performed followed by a first-in-human clinical investigation. NMIBC is associated with frequent recurrence, requiring repeated transurethral resection of the bladder (TUR-B) under anaesthesia, resulting in substantial healthcare burden. The Multi4 instrument integrates local anaesthesia injection, diathermy biopsy, coagulation and automated tissue retrieval. The primary objective was to determine whether Multi4 provides histologically evaluable biopsies in an outpatient setting, and secondary objectives included safety, usability, patient-reported outcomes and health-economic impact.
methodsPreclinical in vivo evaluation was performed in 13 pigs to assess safety, biopsy quality, coagulation efficacy and perforation risk. A prospective, open-label, single-arm clinical investigation enrolled 18 adults with recurrent Ta/T1 NMIBC (≤10 mm lesions). Procedures were performed under local anaesthesia using flexible cystoscopy. The primary endpoint was the proportion of evaluable biopsies. Secondary endpoints included adverse events, usability, pain (0-10 scale), EQ-5D and cost comparison versus standard TUR-B. Diagnostic yield was also assessed at the patient level.
resultsA total of 550 porcine biopsies demonstrated immediate haemostasis and preserved tissue architecture suitable for histological assessment. Perforation occurred after 7-11 sequential biopsies at the same location, indicating a wide safety margin. Clinically, 134/145 biopsies (92%) were evaluable and the primary endpoint was met. Diagnostic yield per patient was 89%. No device-related adverse events or Clavien-Dindo complications occurred. All procedures were completed under local anaesthesia without conversion to standard TUR-B or use of additional instruments. The median pain score was 0.5/10. Estimated per-procedure cost reduction was 73-89% versus TUR-B.
conclusionsMulti4 enables feasible and safe outpatient biopsy and lesion management of small recurrent NMIBC under local anaesthesia with substantially reduced resource use while maintaining diagnostic reliability.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.