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
AU - Thornburg, Bartley
AU - Casalino, David
AU - Miller, Frank
AU - Hofer, Matthias
AU - Hamoui, Nabeel
AU - Mouli, Samdeep
N1 - Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/10
Y1 - 2018/10
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 (Q max ) ≤ 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 Q max 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), Q max (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 Q max (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 (Q max ) ≤ 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 Q max 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), Q max (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 Q max (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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U2 - 10.1016/j.urology.2018.07.012
DO - 10.1016/j.urology.2018.07.012
M3 - Article
C2 - 30036614
AN - SCOPUS:85053038241
VL - 120
SP - 205
EP - 210
JO - Urology
JF - Urology
SN - 0090-4295
ER -