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Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities
PURPOSE: This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. MATERIALS AND METHODS:...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8831058/ https://www.ncbi.nlm.nih.gov/pubmed/35154313 http://dx.doi.org/10.1155/2022/7367851 |
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author | Cambio, Angelo J. Roach, Richard M. Arnold, Paul Cambio, Joseph Gluck, Clifford D. Heron, Sean P. |
author_facet | Cambio, Angelo J. Roach, Richard M. Arnold, Paul Cambio, Joseph Gluck, Clifford D. Heron, Sean P. |
author_sort | Cambio, Angelo J. |
collection | PubMed |
description | PURPOSE: This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. MATERIALS AND METHODS: The Spanner was placed for 3 cycles of 30 days in catheter-dependent men with comorbid conditions, confirmed detrusor contractility, and catheter-associated discomfort. At each visit, postvoid residual, maximum flow rate, international prostate symptom score, quality of life, and adverse events were assessed. Voiding success was defined as PVR ≤ 150 ml at all visits. RESULTS: One hundred seven men were enrolled at 8 US sites; 82/107 (76.6%) completed the trial, and 79/107 (73.8%) successfully maintained PVR ≤ 150 ml for the trial duration. Patients were 77.1 ± 10.6 years old; 63/107 (58.9%) were dependent on Foley and 40/107 (37.4%) on intermittent catheterization for 36.0 ± 39.3 days and 30.2 ± 45.8 days, respectively. 25/107 (23.4%) discontinuations were primarily due to voluntary patient withdrawal 9/107 (8.4%), investigator-initiated withdrawal 8/107 (7.5%), or lack of effectiveness 4/107 (3.7%). During Spanner use, the mean Q(max) was 11.2 ± 6.6, mean IPSS was 7.5 ± 6.4, and mean QOL was 2.0 ± 1.6. The most prevalent device-related adverse events were asymptomatic bacteriuria 25/107 (23.4%), discomfort 10/107 (9.4%), and urinary urgency 8/107 (7.5%). No device-related serious AEs were reported. CONCLUSIONS: This study demonstrates that catheter-dependent men with sufficient bladder contractility can achieve volitional voiding and successful bladder drainage using The Spanner Temporary Prostatic Stent for extended periods of time. |
format | Online Article Text |
id | pubmed-8831058 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-88310582022-02-11 Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities Cambio, Angelo J. Roach, Richard M. Arnold, Paul Cambio, Joseph Gluck, Clifford D. Heron, Sean P. Adv Urol Research Article PURPOSE: This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. MATERIALS AND METHODS: The Spanner was placed for 3 cycles of 30 days in catheter-dependent men with comorbid conditions, confirmed detrusor contractility, and catheter-associated discomfort. At each visit, postvoid residual, maximum flow rate, international prostate symptom score, quality of life, and adverse events were assessed. Voiding success was defined as PVR ≤ 150 ml at all visits. RESULTS: One hundred seven men were enrolled at 8 US sites; 82/107 (76.6%) completed the trial, and 79/107 (73.8%) successfully maintained PVR ≤ 150 ml for the trial duration. Patients were 77.1 ± 10.6 years old; 63/107 (58.9%) were dependent on Foley and 40/107 (37.4%) on intermittent catheterization for 36.0 ± 39.3 days and 30.2 ± 45.8 days, respectively. 25/107 (23.4%) discontinuations were primarily due to voluntary patient withdrawal 9/107 (8.4%), investigator-initiated withdrawal 8/107 (7.5%), or lack of effectiveness 4/107 (3.7%). During Spanner use, the mean Q(max) was 11.2 ± 6.6, mean IPSS was 7.5 ± 6.4, and mean QOL was 2.0 ± 1.6. The most prevalent device-related adverse events were asymptomatic bacteriuria 25/107 (23.4%), discomfort 10/107 (9.4%), and urinary urgency 8/107 (7.5%). No device-related serious AEs were reported. CONCLUSIONS: This study demonstrates that catheter-dependent men with sufficient bladder contractility can achieve volitional voiding and successful bladder drainage using The Spanner Temporary Prostatic Stent for extended periods of time. Hindawi 2022-02-03 /pmc/articles/PMC8831058/ /pubmed/35154313 http://dx.doi.org/10.1155/2022/7367851 Text en Copyright © 2022 Angelo J. Cambio et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Cambio, Angelo J. Roach, Richard M. Arnold, Paul Cambio, Joseph Gluck, Clifford D. Heron, Sean P. Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
title | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
title_full | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
title_fullStr | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
title_full_unstemmed | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
title_short | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
title_sort | extended use of the spanner® temporary prostatic stent in catheter-dependent men with comorbidities |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8831058/ https://www.ncbi.nlm.nih.gov/pubmed/35154313 http://dx.doi.org/10.1155/2022/7367851 |
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