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Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study
Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760566/ https://www.ncbi.nlm.nih.gov/pubmed/30542055 http://dx.doi.org/10.1038/s41391-018-0118-x |
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author | Rukstalis, Daniel Grier, Douglas Stroup, Sean P. Tutrone, Ronald deSouza, Euclid Freedman, Sheldon David, Richard Kamientsky, Jed Eure, Gregg |
author_facet | Rukstalis, Daniel Grier, Douglas Stroup, Sean P. Tutrone, Ronald deSouza, Euclid Freedman, Sheldon David, Richard Kamientsky, Jed Eure, Gregg |
author_sort | Rukstalis, Daniel |
collection | PubMed |
description | Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73–94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66–89%) reported being “much” or “very much better,” and 89% (CI 76–95%) would recommend the procedure. Compared to LL subjects, OML subjects’ symptoms improved at least as much at every time point (OML range 13.5–15.9, LL range 9.9–11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63–81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30–51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively. |
format | Online Article Text |
id | pubmed-6760566 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-67605662019-09-26 Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study Rukstalis, Daniel Grier, Douglas Stroup, Sean P. Tutrone, Ronald deSouza, Euclid Freedman, Sheldon David, Richard Kamientsky, Jed Eure, Gregg Prostate Cancer Prostatic Dis Article Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73–94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66–89%) reported being “much” or “very much better,” and 89% (CI 76–95%) would recommend the procedure. Compared to LL subjects, OML subjects’ symptoms improved at least as much at every time point (OML range 13.5–15.9, LL range 9.9–11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63–81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30–51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively. Nature Publishing Group UK 2018-12-12 2019 /pmc/articles/PMC6760566/ /pubmed/30542055 http://dx.doi.org/10.1038/s41391-018-0118-x Text en © The Author(s) 2018 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Article Rukstalis, Daniel Grier, Douglas Stroup, Sean P. Tutrone, Ronald deSouza, Euclid Freedman, Sheldon David, Richard Kamientsky, Jed Eure, Gregg Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study |
title | Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study |
title_full | Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study |
title_fullStr | Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study |
title_full_unstemmed | Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study |
title_short | Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study |
title_sort | prostatic urethral lift (pul) for obstructive median lobes: 12 month results of the medlift study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760566/ https://www.ncbi.nlm.nih.gov/pubmed/30542055 http://dx.doi.org/10.1038/s41391-018-0118-x |
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