Antimicrobial Lubricant Did Not Reduce Infection Rate in Transrectal Biopsy Patients in a Large Randomized Trial Due to Low Complication Rates.


Journal

European urology focus
ISSN: 2405-4569
Titre abrégé: Eur Urol Focus
Pays: Netherlands
ID NLM: 101665661

Informations de publication

Date de publication:
11 2019
Historique:
received: 13 04 2018
revised: 21 05 2018
accepted: 08 06 2018
pubmed: 27 6 2018
medline: 3 11 2020
entrez: 27 6 2018
Statut: ppublish

Résumé

Transrectal prostate biopsy (pbx) is the most frequent outpatient procedure in the urological field. Septic complications are a major health issue. To evaluate complication rates with or without an antimicrobial lubricant. A total of 1000 patients received pbx between 2013 and 2015. Information about complications was collected by a 3-wk questionnaire. Return rate was 73.2% (n=732). Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed. Multivariable analyses assessed the association between infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders. The use of an antimicrobial lubricant did not reduce infection rate. Overall complication rate was very low. Of all patients, 69.3% described the procedure as pain free. Fever ≥38.5°C was reported in overall 1.9% of patients. Urinary retention with catheterization occurred in 3.1%. Most common complications were hematospermia (47.4%), macrohematuria (23.8%), and rectal bleeding (7.4%). Readmission rate was 1% (n=7). In multivariable analyses, IPSS and previous infectious complications were associated with a higher risk of infectious complications. Our results stem from a large German single center and therefore are limited to this patient group. No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent. Low incidence of those complications may be the underlying cause. Severe morbidity at pbx is uncommon. Specifically, the rate of infection was very low. Severe complications at prostate biopsy are rare. Among participants, 69.3% had no pain. Fever was rare (1.9% of patients). Voiding issues with catheterization occurred in 3.1%. Most common complications were blood in the semen (47.4%), urine (23.8%), or stool (7.4%). Men with voiding issues or previous infectious complications had a higher risk of infectious complications.

Sections du résumé

BACKGROUND
Transrectal prostate biopsy (pbx) is the most frequent outpatient procedure in the urological field. Septic complications are a major health issue.
OBJECTIVE
To evaluate complication rates with or without an antimicrobial lubricant.
DESIGN, SETTING, AND PARTICIPANTS
A total of 1000 patients received pbx between 2013 and 2015. Information about complications was collected by a 3-wk questionnaire. Return rate was 73.2% (n=732).
INTERVENTION
Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Multivariable analyses assessed the association between infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders.
RESULTS AND LIMITATIONS
The use of an antimicrobial lubricant did not reduce infection rate. Overall complication rate was very low. Of all patients, 69.3% described the procedure as pain free. Fever ≥38.5°C was reported in overall 1.9% of patients. Urinary retention with catheterization occurred in 3.1%. Most common complications were hematospermia (47.4%), macrohematuria (23.8%), and rectal bleeding (7.4%). Readmission rate was 1% (n=7). In multivariable analyses, IPSS and previous infectious complications were associated with a higher risk of infectious complications. Our results stem from a large German single center and therefore are limited to this patient group.
CONCLUSIONS
No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent. Low incidence of those complications may be the underlying cause. Severe morbidity at pbx is uncommon. Specifically, the rate of infection was very low.
PATIENT SUMMARY
Severe complications at prostate biopsy are rare. Among participants, 69.3% had no pain. Fever was rare (1.9% of patients). Voiding issues with catheterization occurred in 3.1%. Most common complications were blood in the semen (47.4%), urine (23.8%), or stool (7.4%). Men with voiding issues or previous infectious complications had a higher risk of infectious complications.

Identifiants

pubmed: 29941389
pii: S2405-4569(18)30153-6
doi: 10.1016/j.euf.2018.06.005
pii:
doi:

Substances chimiques

Anti-Bacterial Agents 0
Lubricants 0

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

992-997

Informations de copyright

Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Auteurs

Georg Salomon (G)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Sandra Prues (S)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Judith Saul (J)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Lars Budäus (L)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Derya Tilki (D)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Meike Schneider (M)

Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.

Axel Haferkamp (A)

Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.

Markus Graefen (M)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Katharina Boehm (K)

Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany. Electronic address: katharina.boehm@unimedizin-mainz.de.

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