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A Prospective Single-Center 3 Year Study of the Efficacy and Safety of the GreenLight Laser HPS in Men with Clinical BPH
Gregg Eure
Eastern Virginia Medical School, Virginia Beach, VA

Introduction: To demonstrate safety and efficacy of treatment with the 532 nm KTP (120 watt) laser for patients with male lower urinary tract symptoms (LUTS) and clinical benign prostatic hyperplasia (BPH) in a prospective single surgeon study under a unified protocol.
Materials & Methods: A prospective, single-arm study with a single surgeon conducted in the US. Thirty-five consectutive patients were enrolled and 33 underwent treatment with the KTP 532 nm laser. The study included subjects aged ≥ 45 years who were indicated for surgical intervention for obstructive BPH. Subjects are followed at 3 months, 6 months, 1 year, and annually through 5 years. Mean age was 65.6+7.7 years.
All actively participating subjects have completed at least 2 years of follow-up. Length of stay was 3.9+4.4 hrs, length of catheterization 21.7+3.2 hrs, procedure time was 55.9+23.4 min, and total energy used 189+84.8 kJ. The table shows baseline and follow-up data with mean+SD.

Baseline3 mo6 mo12 mo24 mo
Qmax (ml/s)12.4+4.921.9+8.921.0+8.619.9+9.218.0+9.0
PVR (ml)109.8+81.360.6+51.369.0+52.762.7+36.664.7+38.7
TRUS (cc)67.2+31.534.7+22.8

Adverse events were all mild including urgency, dysuria, retrograde ejaculation and hematuria with the exception of 1 bladder neck contracture. Conclusions:
In this single-center prospective single arm study, the 532 nm KTP laser provided 17.2 point (72.3%) improvement in IPSS at 24 mo, with a commensurate QoL improvement, reduction in PVR and improvement in Qmax, while inducing a volume decrease of 48.4%. Observed AEs were as expected for surgical ablation of prostate tissue.

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