Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Standard

Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers. / Bagi, Per; Hannibalsen, Jane; Permild, Rikke; Stilling, Sine; Looms, Dagnia K.

I: Urologia Internationalis, Bind 86, Nr. 2, 27.01.2011, s. 179-84.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Bagi, P, Hannibalsen, J, Permild, R, Stilling, S & Looms, DK 2011, 'Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers', Urologia Internationalis, bind 86, nr. 2, s. 179-84. https://doi.org/10.1159/000321900

APA

Bagi, P., Hannibalsen, J., Permild, R., Stilling, S., & Looms, D. K. (2011). Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers. Urologia Internationalis, 86(2), 179-84. https://doi.org/10.1159/000321900

Vancouver

Bagi P, Hannibalsen J, Permild R, Stilling S, Looms DK. Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers. Urologia Internationalis. 2011 jan 27;86(2):179-84. https://doi.org/10.1159/000321900

Author

Bagi, Per ; Hannibalsen, Jane ; Permild, Rikke ; Stilling, Sine ; Looms, Dagnia K. / Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers. I: Urologia Internationalis. 2011 ; Bind 86, Nr. 2. s. 179-84.

Bibtex

@article{3b8bb8ab28a340a395e070ca36c9eb84,
title = "Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers",
abstract = "Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95{\%} confidence interval -0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3{\%} of catheterizations; p <0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. Conclusions: Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved.",
author = "Per Bagi and Jane Hannibalsen and Rikke Permild and Sine Stilling and Looms, {Dagnia K}",
note = "Copyright {\circledC} 2011 S. Karger AG, Basel.",
year = "2011",
month = "1",
day = "27",
doi = "10.1159/000321900",
language = "English",
volume = "86",
pages = "179--84",
journal = "Urologia Internationalis",
issn = "0042-1138",
publisher = "S Karger AG",
number = "2",

}

RIS

TY - JOUR

T1 - Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

AU - Bagi, Per

AU - Hannibalsen, Jane

AU - Permild, Rikke

AU - Stilling, Sine

AU - Looms, Dagnia K

N1 - Copyright © 2011 S. Karger AG, Basel.

PY - 2011/1/27

Y1 - 2011/1/27

N2 - Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p <0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. Conclusions: Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved.

AB - Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p <0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. Conclusions: Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved.

U2 - 10.1159/000321900

DO - 10.1159/000321900

M3 - Journal article

C2 - 21273758

VL - 86

SP - 179

EP - 184

JO - Urologia Internationalis

JF - Urologia Internationalis

SN - 0042-1138

IS - 2

ER -

ID: 34145945