Local analgesia during flexible cystoscopy in male patients : A non-inferiority study comparing Xylocaine® gel to Instillagel® Lido
Copyright © 2016 Elsevier Masson SAS. All rights reserved..
INTRODUCTION: Local anesthesia using urethral gel has been proven to reduce discomfort of male patients during flexible cystoscopy. This study was a non-inferiority study between two lidocain-containing urethral gel (Instillagel® Lido and Xylocaine® gel).
METHODS: A prospective single center study was conducted between June 2014 and November 2014. Male patients seen in the office and in whom a flexible cystoscopy was planned were included in the present study and received urethral instillation of either Xylocaine® gel or Instillagel® Lido at least 5minutes before flexible cystoscopy. No other anesthetic agent was used. Primary endpoint was pain during the procedure, assessed through visual analog scale (VAS) from 0 to 10.
RESULTS: Four hundred and sixty-one men were included: 233 in the Instillagel® Lido group and 228 in the Xylocaine® gel group. Indications of flexible cystoscopy non-muscle invasive bladder cancer follow-up in 44 % of cases, hematuria work-up in 21 % of cases and lower urinary tract symptoms work-up in 35 %. Patients' age was comparable betwwen both groups: 64.5 years (±1.1) in the Instillagel® Lido group and 66.2 years (±1.1) in the Xylocaine® gel group (P=0.29). The mean VAS was 0.8 (±0.1) in the Instillagel® Lido group and 0.6 (±0.1) in the Xylocaine® gel group (P=0.10). The non-inferiority criterion was reached (P<0.001) as the average difference in VAS between the two groups was 0.2 with a confidence interval not comprising 1 (CI 97.5 %: -0.47; 0.07).
CONCLUSION: In this prospective study, Instillagel® Lido was not inferior to Xylocaine® gel for local analgesia during flexible cystoscopy in male patients.
LEVEL OF EVIDENCE: 4.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
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| Enthalten in: |
Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie - 26(2016), 11-12 vom: 20. Sept., Seite 651-655 |
| Sprache: |
Französisch |
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| Weiterer Titel: |
Anesthésie locale pour fibroscopie chez l’homme : étude de non-infériorité comparant le Xylocaine® gel à l’Instillagel® Lido |
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| Beteiligte Personen: |
Peyronnet, B [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 07.07.2017 Date Revised 07.07.2017 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.purol.2016.09.049 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM265073707 |
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| 245 | 1 | 0 | |a Local analgesia during flexible cystoscopy in male patients |b A non-inferiority study comparing Xylocaine® gel to Instillagel® Lido |
| 246 | 3 | 3 | |a Anesthésie locale pour fibroscopie chez l’homme : étude de non-infériorité comparant le Xylocaine® gel à l’Instillagel® Lido |
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| 500 | |a Date Revised 07.07.2017 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2016 Elsevier Masson SAS. All rights reserved. | ||
| 520 | |a INTRODUCTION: Local anesthesia using urethral gel has been proven to reduce discomfort of male patients during flexible cystoscopy. This study was a non-inferiority study between two lidocain-containing urethral gel (Instillagel® Lido and Xylocaine® gel) | ||
| 520 | |a METHODS: A prospective single center study was conducted between June 2014 and November 2014. Male patients seen in the office and in whom a flexible cystoscopy was planned were included in the present study and received urethral instillation of either Xylocaine® gel or Instillagel® Lido at least 5minutes before flexible cystoscopy. No other anesthetic agent was used. Primary endpoint was pain during the procedure, assessed through visual analog scale (VAS) from 0 to 10 | ||
| 520 | |a RESULTS: Four hundred and sixty-one men were included: 233 in the Instillagel® Lido group and 228 in the Xylocaine® gel group. Indications of flexible cystoscopy non-muscle invasive bladder cancer follow-up in 44 % of cases, hematuria work-up in 21 % of cases and lower urinary tract symptoms work-up in 35 %. Patients' age was comparable betwwen both groups: 64.5 years (±1.1) in the Instillagel® Lido group and 66.2 years (±1.1) in the Xylocaine® gel group (P=0.29). The mean VAS was 0.8 (±0.1) in the Instillagel® Lido group and 0.6 (±0.1) in the Xylocaine® gel group (P=0.10). The non-inferiority criterion was reached (P<0.001) as the average difference in VAS between the two groups was 0.2 with a confidence interval not comprising 1 (CI 97.5 %: -0.47; 0.07) | ||
| 520 | |a CONCLUSION: In this prospective study, Instillagel® Lido was not inferior to Xylocaine® gel for local analgesia during flexible cystoscopy in male patients | ||
| 520 | |a LEVEL OF EVIDENCE: 4 | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anesthesia | |
| 650 | 4 | |a Anesthésie | |
| 650 | 4 | |a Cystoscopie | |
| 650 | 4 | |a Cystoscopy | |
| 650 | 4 | |a Gel | |
| 650 | 4 | |a Homme | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Urethra | |
| 650 | 4 | |a Urètre | |
| 650 | 7 | |a Anesthetics, Local |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
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| 650 | 7 | |a chlorhexidine gluconate, lidocaine drug combination |2 NLM | |
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| 700 | 1 | |a Phé, V |e verfasserin |4 aut | |
| 700 | 1 | |a Rouprêt, M |e verfasserin |4 aut | |
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