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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.
Results:
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. | Baseline | 3 mo | 6 mo | 12 mo | 24 mo | | IPSS | 23.8+4.7 | 7.8+4.5 | 5.0+3.2 | 6.1+4.6 | 6.6+4.5 | | QoL | 4.4+1.2 | 1.3+1.3 | 1.0+1.1 | 0.9+1.0 | 1.3+1.0 | | Qmax (ml/s) | 12.4+4.9 | 21.9+8.9 | 21.0+8.6 | 19.9+9.2 | 18.0+9.0 | | PVR (ml) | 109.8+81.3 | 60.6+51.3 | 69.0+52.7 | 62.7+36.6 | 64.7+38.7 | | TRUS (cc) | 67.2+31.5 | | 34.7+22.8 | | | | PSA | 2.5+1.6 | | 2.2+2.2 | 2.7+2.2 | 3.3+2.7 |
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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