Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle – a randomized controlled non-inferiority trial

Abstract

Background: Transrectal prostate biopsy (TRbx) carries an increasing risk of infection. The Forsvall Needle Prototype (FNP) is a novel biopsy needle that reduces bacterial load brought across the rectum and may therefore reduce infection risk. The objective of this study was to compare biopsy length, quality and patient experience for the FNP Version 2 (FNP2) versus a standard Tru-Cut needle. Methods: We conducted a randomized, parallel-group, non-inferiority trial with twenty consecutive patients eligible for TRbx. Participants were randomized to undergo TRbx using either FNP2 or a standard Tru-Cut needle. The primary outcome was difference in mean biopsy lengths measured by the pathologist. FNP2 biopsy lengths 1.35 mm of the standard needle length were considered noninferior. Secondary outcomes were biopsy length in the needle chamber and immediately after removal, biopsy quality, biopsy fragmentation, patient discomfort/pain, and complications (immediate and after 14 and 30 days). Results: Mean pathologist-measured FNP2 biopsy length was non-inferior compared to the standard Tru-Cut needle (0.02 mm longer, 95%CI-0.73 to 0.76 mm). Biopsy length in the needle chamber and immediately after removal were also non-inferior. Biopsy quality and patient discomfort were not significantly different for the FNP2 and the standard Tru-Cut needle. Biopsy fragmentation was more common in the FNP2 group. Conclusions: The FNP2 biopsy needle is non-inferior to the Tru-Cut needle in terms of biopsy length and not significantly different in terms of biopsy quality and patient experience. Future studies will evaluate the Forsvall needle design's effect on post-biopsy infection risk.

Evaluation of the Forsvall biopsy needle in anex vivomodel of transrectal prostate biopsy – a novel needle design with the objective to reduce the risk of post-biopsy infection

“…In conclusion, we have shown that a smooth, forcedclosed needle design significantly reduces bacterial transfer across the rectal wall in TRbx and is therefore likely to reduce the risk of infectious complications in TRbx. A clinical trial evaluating the quality of prostate specimens obtained by the Forsvall needle has been completed [15] and its ability to reduce infectious complications will be studied further in a prospective, randomized multicentre trial.…”

PI-RADS v2.1 evaluation of prostate “nodule in nodule” variants: clinical, imaging, and pathological features

“…1 . The nodules determined by mpMRI scanning were biopsied through the rectum under ultrasound guidance by experienced urologists using the same method as described in previous studies [ 13 , 14 ].

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