Publication
Title
Minimal device encrustation on vesair intravesical balloons in the treatment of stress urinary incontinence : analysis of balloons removed from women in the SOLECT trial
Author
Abstract
Introduction: Encrustation of urinary biomaterials is common; however, the incidence of surface deposition on the Vesair (R) intravesical pressure-attenuation balloon has not been previously reported. The purpose of this analysis is to determine the incidence and potential risk factors for encrustation of the Vesair intravesical balloon. Methods: The SOLECT trial is a prospective randomized controlled trial conducted at several European centers to evaluate the safety and efficacy of the Vesair balloon for the treatment of female stress urinary incontinence (SUI). Women included in the study demonstrated SUI symptoms for more than 12 months without complicating factors, such as history of recurrent urinary tract infections or nephrolithiasis. All balloons removed from women enrolled in the SOLECT trial were analyzed for surface characteristics and encrustation. Surface deposition severity was quantified and composition analyzed with infrared spectroscopy and scanning electron microscopy. Incidence of surface deposition was tabulated and risk factors analyzed. Results: One hundred and five balloons removed from 75 women were included in this analysis. Measurable stone deposition of less than 1.5 mm was found on four balloons (3.8%), surface granules were noted on 42 (40.0%), surface film on 11 (10.5%), and both granules and film on two (1.9%). Analysis identified calcium oxalate both in measurable encrustation deposits as well as those with surface granulation. Pooled analysis found that dwell time was a risk factor for calcium deposition. Conclusion: The rate of encrustation on the Vesair intravesical balloon is low and does not appear to increase the rate of adverse outcomes or reduce clinical efficacy.
Language
English
Source (journal)
Advances in therapy : the international journal of drug, device & diagnostic research. - Chester, 1984, currens
Publication
Chester : Springer , 2017
ISSN
0741-238X [print]
1865-8652 [online]
DOI
10.1007/S12325-017-0570-3
Volume/pages
34 :7 (2017) , p. 1686-1694
ISI
000405286200014
Pubmed ID
28597355
Full text (Publisher's DOI)
Full text (open access)
UAntwerpen
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Research group
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Publication type
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Affiliation
Publications with a UAntwerp address
External links
Web of Science
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Creation 17.08.2017
Last edited 28.01.2024
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