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Tissue response to applied loading using different designs of penile compression clamps

Tissue response to applied loading using different designs of penile compression clamps
Tissue response to applied loading using different designs of penile compression clamps
Background: penile compression devices (PCD) or clamps are applied to compress the urethra and prevent urinary incontinence (UI). PCDs are more secure and less likely to leak than pads, allowing men the opportunity to participate in short-term, vigorous activities. However, they are uncomfortable, can cause pressure ulcers (PU) and affect penile blood flow. No objective assessment of tissue health has been undertaken to assess and compare different PCD designs and to provide guidance on safe use.

Objective: this study was designed to evaluate existing PCDs in terms of their physiological response and potential for pressure-induced injury.

Design, setting and participants: six men with post-prostatectomy UI tested four selected PCDs at effective pressures, in a random order, in a controlled laboratory setting.

Outcome measurements and statistical analysis: using objective methods for assessing skin injury, PCDs were measured in situ for their effects on circulatory impedance, interface pressures and inflammatory response.

Results and limitations: there was evidence for PCD-induced circulatory impedance in most test conditions. Interface pressures varied considerably between both PCDs and participants, with a mean value of 137.4±69.7 mmHg. In some cases, penile skin was noted to be sensitive to loading with elevated concentration of the cytokine IL-1α after 10 mins wear, indicating an inflammatory response. IL-1α levels were restored to baseline 40 mins following PCD removal.

Conclusion: skin health measures indicated tissue and blood flow compromise during the 50 mins of testing using all PCDs. Although there was an elevation in pro-inflammatory cytokines, PCDs did not cause sustained irritation and skin health measures recovered 40 mins after PCD removal. This research indicates that application of a clamp for one hour with an equal clamp free time before reapplication is likely to be safe. Longer periods are often recommended by manufacturers but have yet to be tested.
1179-1470
235-243
Lemmens, Joseph Mh
3dd930fa-c49b-4153-be26-37759369944b
Broadbridge, Jackie
7dbea295-7135-4260-af4d-c5c76e2553c4
Macaulay, Margaret
505970d3-1e67-4c1f-8291-3a950d336c6b
Rees, Rowland W
4180ed50-e1eb-4f41-90e8-9e9ccb0aba18
Archer, Matt
c08e9a9c-d1bc-420d-91ab-924781043ab2
Drake, Marcus J
60d630c3-0d89-4513-94b6-72671bd28b94
Moore, Katherine N
a579bf99-6450-4185-98fa-bf15c8478eef
Bader, Dan L
9884d4f6-2607-4d48-bf0c-62bdcc0d1dbf
Fader, Mandy
c318f942-2ddb-462a-9183-8b678faf7277
Lemmens, Joseph Mh
3dd930fa-c49b-4153-be26-37759369944b
Broadbridge, Jackie
7dbea295-7135-4260-af4d-c5c76e2553c4
Macaulay, Margaret
505970d3-1e67-4c1f-8291-3a950d336c6b
Rees, Rowland W
4180ed50-e1eb-4f41-90e8-9e9ccb0aba18
Archer, Matt
c08e9a9c-d1bc-420d-91ab-924781043ab2
Drake, Marcus J
60d630c3-0d89-4513-94b6-72671bd28b94
Moore, Katherine N
a579bf99-6450-4185-98fa-bf15c8478eef
Bader, Dan L
9884d4f6-2607-4d48-bf0c-62bdcc0d1dbf
Fader, Mandy
c318f942-2ddb-462a-9183-8b678faf7277

Lemmens, Joseph Mh, Broadbridge, Jackie, Macaulay, Margaret, Rees, Rowland W, Archer, Matt, Drake, Marcus J, Moore, Katherine N, Bader, Dan L and Fader, Mandy (2019) Tissue response to applied loading using different designs of penile compression clamps. Medical Devices Evidence and Research, 12, 235-243. (doi:10.2147/MDER.S188888).

Record type: Article

Abstract

Background: penile compression devices (PCD) or clamps are applied to compress the urethra and prevent urinary incontinence (UI). PCDs are more secure and less likely to leak than pads, allowing men the opportunity to participate in short-term, vigorous activities. However, they are uncomfortable, can cause pressure ulcers (PU) and affect penile blood flow. No objective assessment of tissue health has been undertaken to assess and compare different PCD designs and to provide guidance on safe use.

Objective: this study was designed to evaluate existing PCDs in terms of their physiological response and potential for pressure-induced injury.

Design, setting and participants: six men with post-prostatectomy UI tested four selected PCDs at effective pressures, in a random order, in a controlled laboratory setting.

Outcome measurements and statistical analysis: using objective methods for assessing skin injury, PCDs were measured in situ for their effects on circulatory impedance, interface pressures and inflammatory response.

Results and limitations: there was evidence for PCD-induced circulatory impedance in most test conditions. Interface pressures varied considerably between both PCDs and participants, with a mean value of 137.4±69.7 mmHg. In some cases, penile skin was noted to be sensitive to loading with elevated concentration of the cytokine IL-1α after 10 mins wear, indicating an inflammatory response. IL-1α levels were restored to baseline 40 mins following PCD removal.

Conclusion: skin health measures indicated tissue and blood flow compromise during the 50 mins of testing using all PCDs. Although there was an elevation in pro-inflammatory cytokines, PCDs did not cause sustained irritation and skin health measures recovered 40 mins after PCD removal. This research indicates that application of a clamp for one hour with an equal clamp free time before reapplication is likely to be safe. Longer periods are often recommended by manufacturers but have yet to be tested.

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Accepted/In Press date: 22 March 2019
Published date: 17 June 2019

Identifiers

Local EPrints ID: 432145
URI: http://eprints.soton.ac.uk/id/eprint/432145
ISSN: 1179-1470
PURE UUID: c29def53-5650-4444-a08b-89198c4b6adc
ORCID for Margaret Macaulay: ORCID iD orcid.org/0000-0003-1737-4589
ORCID for Dan L Bader: ORCID iD orcid.org/0000-0002-1208-3507

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Date deposited: 03 Jul 2019 16:30
Last modified: 07 Oct 2020 02:17

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Contributors

Author: Joseph Mh Lemmens
Author: Rowland W Rees
Author: Matt Archer
Author: Marcus J Drake
Author: Katherine N Moore
Author: Dan L Bader ORCID iD
Author: Mandy Fader

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