Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study

Riad Salem*, John Hairston, Elias Hohlastos, Ahsun Riaz, Joseph Kallini, Ahmed Gabr, Rehan Ali, Kimberly Jenkins, Jennifer Karp, Kush R Desai, Bartley Garver Thornburg, David Casalino, Frank H Miller, Matthias Dominikus Hofer, Nabeel Hamoui, Samdeep K Mouli

*Corresponding author for this work

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Objective: To evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Methods: A prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results: 45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P <.0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P <.0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P <.0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P <.0001), QoL (2.4 ± 1.6, P <.0001) and Qmax (15.3 ± 12.3, P <.0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P <.0001) and QoL (2.3 ± 1.7, P <.0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P <.0001) and QoL (2.6 ± 1.6, P <.0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P =.057, 3 months 127 ± 114, P =.34, 6 months 112±116, P =.002 and 1 year 109±116 P =.025. Median decreases in TV and CG were 18% (CI: 13-27) (P = 0.0001) and 27% (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. Conclusion: This prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.

Original languageEnglish (US)
Pages (from-to)205-210
Number of pages6
JournalUrology
Volume120
DOIs
StatePublished - Oct 1 2018

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Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Prostate
Arteries
Equipment and Supplies
Quality of Life
Reproductive Health
Hemospermia
Safety
Dysuria
Residual Volume
Hematuria

ASJC Scopus subject areas

  • Urology

Cite this

@article{5bb7c232eb764a7aa9acc4f68f6a1abc,
title = "Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study",
abstract = "Objective: To evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Methods: A prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results: 45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P <.0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P <.0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P <.0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P <.0001), QoL (2.4 ± 1.6, P <.0001) and Qmax (15.3 ± 12.3, P <.0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P <.0001) and QoL (2.3 ± 1.7, P <.0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P <.0001) and QoL (2.6 ± 1.6, P <.0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P =.057, 3 months 127 ± 114, P =.34, 6 months 112±116, P =.002 and 1 year 109±116 P =.025. Median decreases in TV and CG were 18{\%} (CI: 13-27) (P = 0.0001) and 27{\%} (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. Conclusion: This prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.",
author = "Riad Salem and John Hairston and Elias Hohlastos and Ahsun Riaz and Joseph Kallini and Ahmed Gabr and Rehan Ali and Kimberly Jenkins and Jennifer Karp and Desai, {Kush R} and Thornburg, {Bartley Garver} and David Casalino and Miller, {Frank H} and Hofer, {Matthias Dominikus} and Nabeel Hamoui and Mouli, {Samdeep K}",
year = "2018",
month = "10",
day = "1",
doi = "10.1016/j.urology.2018.07.012",
language = "English (US)",
volume = "120",
pages = "205--210",
journal = "Urology",
issn = "0090-4295",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

T2 - Results From a Prospective FDA-Approved Investigational Device Exemption Study

AU - Salem, Riad

AU - Hairston, John

AU - Hohlastos, Elias

AU - Riaz, Ahsun

AU - Kallini, Joseph

AU - Gabr, Ahmed

AU - Ali, Rehan

AU - Jenkins, Kimberly

AU - Karp, Jennifer

AU - Desai, Kush R

AU - Thornburg, Bartley Garver

AU - Casalino, David

AU - Miller, Frank H

AU - Hofer, Matthias Dominikus

AU - Hamoui, Nabeel

AU - Mouli, Samdeep K

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Objective: To evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Methods: A prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results: 45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P <.0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P <.0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P <.0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P <.0001), QoL (2.4 ± 1.6, P <.0001) and Qmax (15.3 ± 12.3, P <.0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P <.0001) and QoL (2.3 ± 1.7, P <.0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P <.0001) and QoL (2.6 ± 1.6, P <.0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P =.057, 3 months 127 ± 114, P =.34, 6 months 112±116, P =.002 and 1 year 109±116 P =.025. Median decreases in TV and CG were 18% (CI: 13-27) (P = 0.0001) and 27% (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. Conclusion: This prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.

AB - Objective: To evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Methods: A prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results: 45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P <.0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P <.0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P <.0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P <.0001), QoL (2.4 ± 1.6, P <.0001) and Qmax (15.3 ± 12.3, P <.0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P <.0001) and QoL (2.3 ± 1.7, P <.0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P <.0001) and QoL (2.6 ± 1.6, P <.0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P =.057, 3 months 127 ± 114, P =.34, 6 months 112±116, P =.002 and 1 year 109±116 P =.025. Median decreases in TV and CG were 18% (CI: 13-27) (P = 0.0001) and 27% (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. Conclusion: This prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.

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