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

Forsvall, Andreas LU orcid ; Fisher, Jane LU ; Wagenius, Magnus LU ; Broman, Christian ; Korkocic, Dejan ; Bratt, Ola and Linder, Adam LU (2021) In Scandinavian Journal of Urology 55(3). p.235-241
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... (More)

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 non-inferior. 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.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
biopsy core length, biopsy quality, post-biopsy infection, Prostate biopsy, transrectal prostate biopsy
in
Scandinavian Journal of Urology
volume
55
issue
3
pages
7 pages
publisher
Taylor & Francis
external identifiers
  • pmid:33999764
  • scopus:85106054538
ISSN
2168-1805
DOI
10.1080/21681805.2021.1921024
language
English
LU publication?
yes
id
137b7b12-276b-417a-8c4e-cf410d9a82df
date added to LUP
2022-01-31 18:26:59
date last changed
2024-06-30 01:50:30
@article{137b7b12-276b-417a-8c4e-cf410d9a82df,
  abstract     = {{<p>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 non-inferior. 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.</p>}},
  author       = {{Forsvall, Andreas and Fisher, Jane and Wagenius, Magnus and Broman, Christian and Korkocic, Dejan and Bratt, Ola and Linder, Adam}},
  issn         = {{2168-1805}},
  keywords     = {{biopsy core length; biopsy quality; post-biopsy infection; Prostate biopsy; transrectal prostate biopsy}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{235--241}},
  publisher    = {{Taylor & Francis}},
  series       = {{Scandinavian Journal of Urology}},
  title        = {{Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle–a randomized controlled non-inferiority trial}},
  url          = {{http://dx.doi.org/10.1080/21681805.2021.1921024}},
  doi          = {{10.1080/21681805.2021.1921024}},
  volume       = {{55}},
  year         = {{2021}},
}