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Effect of imipramine on urethral opening pressure: A randomized, double-blind, placebo-controlled crossover study in healthy women

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Standard

Effect of imipramine on urethral opening pressure : A randomized, double-blind, placebo-controlled crossover study in healthy women. / Kornholt, Jonatan; Sonne, David Peick; Riis, Troels; Sonne, Jesper; Klarskov, Niels.

I: Neurourology and Urodynamics, Bind 38, Nr. 4, 2019, s. 1076-1080.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Kornholt, J, Sonne, DP, Riis, T, Sonne, J & Klarskov, N 2019, 'Effect of imipramine on urethral opening pressure: A randomized, double-blind, placebo-controlled crossover study in healthy women', Neurourology and Urodynamics, bind 38, nr. 4, s. 1076-1080. https://doi.org/10.1002/nau.23955

APA

Kornholt, J., Sonne, D. P., Riis, T., Sonne, J., & Klarskov, N. (2019). Effect of imipramine on urethral opening pressure: A randomized, double-blind, placebo-controlled crossover study in healthy women. Neurourology and Urodynamics, 38(4), 1076-1080. https://doi.org/10.1002/nau.23955

Vancouver

Kornholt J, Sonne DP, Riis T, Sonne J, Klarskov N. Effect of imipramine on urethral opening pressure: A randomized, double-blind, placebo-controlled crossover study in healthy women. Neurourology and Urodynamics. 2019;38(4):1076-1080. https://doi.org/10.1002/nau.23955

Author

Kornholt, Jonatan ; Sonne, David Peick ; Riis, Troels ; Sonne, Jesper ; Klarskov, Niels. / Effect of imipramine on urethral opening pressure : A randomized, double-blind, placebo-controlled crossover study in healthy women. I: Neurourology and Urodynamics. 2019 ; Bind 38, Nr. 4. s. 1076-1080.

Bibtex

@article{1f99cff29a934c85af2652b7f9ebea2b,
title = "Effect of imipramine on urethral opening pressure: A randomized, double-blind, placebo-controlled crossover study in healthy women",
abstract = "AIMS: In two open-label trials, imipramine alleviated symptoms in patients with stress urinary incontinence and is therefore used off-label for this indication. However, it has never been confirmed that imipramine increases urethral pressure in a placebo-controlled setting. The purpose of this study was to investigate whether imipramine increases the opening urethral pressure compared to placebo in healthy women using urethral pressure reflectometry.METHODS: A randomized, double-blind, placebo-controlled, crossover study in 16 healthy women. Opening urethral pressure was measured predose and 1 hour after a single dose of 50 mg imipramine or placebo. The washout period was minimum of 1 week. The study was approved by the local ethics committee, conducted according to the Good Clinical Practice guidelines, and registered on ClinicalTrials.gov and EudraCT before recruitment of subjects. Funding was provided by the clinical department.RESULTS: There were no dropouts and no serious adverse events. There were 13 adverse drug reactions related to imipramine in seven subjects, one adverse event related to placebo, and two adverse events related to the measurements with urethral pressure reflectometry. Imipramine compared to placebo increased opening urethral pressure in the resting condition with 6.5 cmH2 O (95% confidence interval [CI]: -0.5, 13.5), P = 0.07, and in the squeeze condition with 7.9 cmH 2 O (95% CI: -0.3, 16.1), P = 0.06.CONCLUSIONS: In conclusion, the increase in opening urethral pressure after imipramine treatment compared to placebo was neither statistically significant nor clinically relevant, and we do therefore not recommend the off-label use of imipramine for the treatment of stress urinary incontinence.",
author = "Jonatan Kornholt and Sonne, {David Peick} and Troels Riis and Jesper Sonne and Niels Klarskov",
note = "{\textcopyright} 2019 Wiley Periodicals, Inc.",
year = "2019",
doi = "10.1002/nau.23955",
language = "English",
volume = "38",
pages = "1076--1080",
journal = "Neurourology and Urodynamics",
issn = "0733-2467",
publisher = "JohnWiley & Sons, Inc.",
number = "4",

}

RIS

TY - JOUR

T1 - Effect of imipramine on urethral opening pressure

T2 - A randomized, double-blind, placebo-controlled crossover study in healthy women

AU - Kornholt, Jonatan

AU - Sonne, David Peick

AU - Riis, Troels

AU - Sonne, Jesper

AU - Klarskov, Niels

N1 - © 2019 Wiley Periodicals, Inc.

PY - 2019

Y1 - 2019

N2 - AIMS: In two open-label trials, imipramine alleviated symptoms in patients with stress urinary incontinence and is therefore used off-label for this indication. However, it has never been confirmed that imipramine increases urethral pressure in a placebo-controlled setting. The purpose of this study was to investigate whether imipramine increases the opening urethral pressure compared to placebo in healthy women using urethral pressure reflectometry.METHODS: A randomized, double-blind, placebo-controlled, crossover study in 16 healthy women. Opening urethral pressure was measured predose and 1 hour after a single dose of 50 mg imipramine or placebo. The washout period was minimum of 1 week. The study was approved by the local ethics committee, conducted according to the Good Clinical Practice guidelines, and registered on ClinicalTrials.gov and EudraCT before recruitment of subjects. Funding was provided by the clinical department.RESULTS: There were no dropouts and no serious adverse events. There were 13 adverse drug reactions related to imipramine in seven subjects, one adverse event related to placebo, and two adverse events related to the measurements with urethral pressure reflectometry. Imipramine compared to placebo increased opening urethral pressure in the resting condition with 6.5 cmH2 O (95% confidence interval [CI]: -0.5, 13.5), P = 0.07, and in the squeeze condition with 7.9 cmH 2 O (95% CI: -0.3, 16.1), P = 0.06.CONCLUSIONS: In conclusion, the increase in opening urethral pressure after imipramine treatment compared to placebo was neither statistically significant nor clinically relevant, and we do therefore not recommend the off-label use of imipramine for the treatment of stress urinary incontinence.

AB - AIMS: In two open-label trials, imipramine alleviated symptoms in patients with stress urinary incontinence and is therefore used off-label for this indication. However, it has never been confirmed that imipramine increases urethral pressure in a placebo-controlled setting. The purpose of this study was to investigate whether imipramine increases the opening urethral pressure compared to placebo in healthy women using urethral pressure reflectometry.METHODS: A randomized, double-blind, placebo-controlled, crossover study in 16 healthy women. Opening urethral pressure was measured predose and 1 hour after a single dose of 50 mg imipramine or placebo. The washout period was minimum of 1 week. The study was approved by the local ethics committee, conducted according to the Good Clinical Practice guidelines, and registered on ClinicalTrials.gov and EudraCT before recruitment of subjects. Funding was provided by the clinical department.RESULTS: There were no dropouts and no serious adverse events. There were 13 adverse drug reactions related to imipramine in seven subjects, one adverse event related to placebo, and two adverse events related to the measurements with urethral pressure reflectometry. Imipramine compared to placebo increased opening urethral pressure in the resting condition with 6.5 cmH2 O (95% confidence interval [CI]: -0.5, 13.5), P = 0.07, and in the squeeze condition with 7.9 cmH 2 O (95% CI: -0.3, 16.1), P = 0.06.CONCLUSIONS: In conclusion, the increase in opening urethral pressure after imipramine treatment compared to placebo was neither statistically significant nor clinically relevant, and we do therefore not recommend the off-label use of imipramine for the treatment of stress urinary incontinence.

U2 - 10.1002/nau.23955

DO - 10.1002/nau.23955

M3 - Journal article

C2 - 30843263

VL - 38

SP - 1076

EP - 1080

JO - Neurourology and Urodynamics

JF - Neurourology and Urodynamics

SN - 0733-2467

IS - 4

ER -

ID: 224386986