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 language | English (US) |
|---|---|
| Pages (from-to) | 205-210 |
| Number of pages | 6 |
| Journal | Urology |
| Volume | 120 |
| DOIs | |
| State | Published - Oct 1 2018 |
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ASJC Scopus subject areas
- Urology
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Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia : Results From a Prospective FDA-Approved Investigational Device Exemption Study. / Salem, Riad; Hairston, John; Hohlastos, Elias; Riaz, Ahsun; Kallini, Joseph; Gabr, Ahmed; Ali, Rehan; Jenkins, Kimberly; Karp, Jennifer; Desai, Kush R; Thornburg, Bartley Garver; Casalino, David; Miller, Frank H; Hofer, Matthias Dominikus; Hamoui, Nabeel; Mouli, Samdeep K.
In: Urology, Vol. 120, 01.10.2018, p. 205-210.Research output: Contribution to journal › Article
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.
UR - http://www.scopus.com/inward/record.url?scp=85053038241&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85053038241&partnerID=8YFLogxK
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 -