Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial.

Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking. To assess the noninferiority of PVP compared with transurethral resection of the prostate (TURP) on urinary symptoms and the superiority of PVP over TURP on length of hospital stay. A multicenter randomized controlled trial was conducted. Patients underwent monopolar TURP or PVP with the GreenLight HPS 120-W laser. International Prostate Symptom Score (IPSS), Euro-QOL questionnaire, uroflowmetry, Danish Prostate Symptom Score Sexual Function Questionnaire, sexual satisfaction, and adverse events were collected at 1, 3, 6, and 12 mo. The two groups were compared using the 95% confidence interval (CI) of median difference for testing noninferiority of the IPSS at 12 mo and the student t test for testing the difference in length of hospital stay. A total of 139 patients (70 vs 69 men in each group) were randomized. Median IPSS scores at 12-mo follow-up were 5 (interquartile range [IQR]: 3-8) for TURP versus 6 (IQR: 3-9) for PVP, and the 95% CI of the difference of the median was equal to -2 to 3. Because the upper limit of the 95% CI was >2 (the noninferiority margin), the hypothesis of noninferiority could not be considered demonstrated. Median length of stay was significantly shorter in the PVP group than in the TURP group, with a median of 1 (IQR: 1-2) versus 2.5 (IQR: 2-3.5), respectively (p<0.0001). Uroflowmetry parameters and complications were comparable in both groups. Sexual outcomes were slightly better in the PVP group without reaching statistical significance. The present study failed to demonstrate the noninferiority of 120-W GreenLight PVP versus TURP on prostate symptoms at 1 yr but showed that PVP was associated with a shorter length of stay in the hospital. NCT01043588.

Lukacs B ，Loeffler J ，Bruyère F ，Blanchet P ，Gelet A ，Coloby P ，De la Taille A ，Lemaire P ，Baron JC ，Cornu JN ，Aout M ，Rousseau H ，Vicaut E ，REVAPRO Study Group ... -  《-》

GreenLight HPS 120-W laser vaporization versus transurethral resection of the prostate for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: a randomized clinical trial with 2-year follow-up.

High-level evidence to support the use of photoselective vaporization of the prostate (PVP) is limited. Assess the efficacy and safety of GreenLight HPS 120-W laser PVP compared with transurethral resection of the prostate (TURP). A randomized clinical trial was performed with 50 patients having lower urinary tract symptoms due to benign prostatic hyperplasia in each treatment arm. Random allocation to PVP or TURP. International Prostate Symptom Score (IPSS), quality of life (QoL), and changes in maximum flow rate (Qmax) were the main end points. Patients were evaluated at a follow-up time of 2 yr. Five patients were lost to follow-up. A last observation carried forward analysis was done. Both laser PVP and TURP resulted in the same IPPS reduction at 2 yr (-15.7 and -14.9, respectively; p=0.48) and in the same gain in Qmax (+14.5 ml/s and +13.1 ml/s, respectively; p=0.65). QoL was equivalent for both treatment modalities. These results were independent of prostate size, American Society of Anesthesiologists risk category, and prior indwelling catheter. No statistically significant differences were detected between arms in terms of complication rates. In the laser PVP group, three patients were readmitted to the hospital and two developed a urethral stricture. In the TURP group, two patients were readmitted, six developed a urethral stricture, and two developed bladder neck sclerosis. In-hospital stay and time to catheter removal were significantly shorter with PVP. Limitations are the potential lack of power to detect differences in the complications between groups and the lack of blindness due to the nature of the intervention. GreenLight HPS 120-W laser PVP is as effective as TURP for symptom reduction and improvement of QoL. No differences were seen in the response of storage and voiding symptoms. Laser PVP and TURP have the same complication rate. Length of stay is shorter for laser PVP group.

Capitán C ，Blázquez C ，Martin MD ，Hernández V ，de la Peña E ，Llorente C ... -  《-》

A randomized trial of photoselective vaporization of the prostate using the 80-W potassium-titanyl-phosphate laser vs transurethral prostatectomy, with a 1-year follow-up.

Bouchier-Hayes DM ，Van Appledorn S ，Bugeja P ，Crowe H ，Challacombe B ，Costello AJ ... -  《-》

GreenLight HPS™ 120-W laser vaporization vs transurethral resection of the prostate (<60 mL): a 2-year randomized double-blind prospective urodynamic investigation.

What's known on the subject? and What does the study add? Photovaporization of the prostate (PVP) is now challenging TURP as the standard treatment for lower LUTS caused by BPH. The learning curve for PVP is short and the main advantages of this method over TURP are a shorter period of hospitalization, a shorter period of postoperative vesical catheterization, lower levels of retrograde ejaculation, rare development of dilutional hyponatraemia syndrome, the lack of a need for postoperative vesical irrigation as a result of extremely low indices of postoperative haematuria, and the lack of a need to suspend anticoagulant medication for the surgery. Traditionally, comparisons of the effectiveness of TURP vs PVP have involved parameters such as peak flow urinary rate and post-void residual urine volume measurements, and have employed questionnaires such as the IPSS and the International Index of Erectile Function instruments. However, studies evaluating detailed urodynamic parameters remain scarce and non-comparative The present study compared postoperative, medium-term urodynamic parameters among patients receiving TURP and high-power PVP. We consider the present study to be distinctive because it involved a double-blind, detailed functional analysis of the vesical emptying stage over the course of 2 years, and did not simply comprise an evaluation of clinical parameters and uroflowmetrics. We saw a reduction of infravesical obstruction, as shown by the significant reduction of ≥20 cm H(2)O in the mean micturition pressure for the groups studied, as well as a significant reduction in bladder outlet obstruction index. Thus, the present data show that high-power PVP can achieve and maintain the same results as TURP over a period of 24 months regarding an aspect that is particularly important for maintaining vesical health (i.e. detrusor pressure during the evacuation of the bladder). Such urodynamic data describing the functional outcome of PVP are currently missing from the literature. To assess the impact of GreenLight HPS™ 120-W (American Medical System Incorporation, Minnetonka, MN, USA) laser photovaporization of the prostate (PVP) compared to transurethral resection of the prostate (TURP) on urodynamic results, voiding function and sexual function. In total, 20 men with intermediate/severe lower urinary tract symptoms as a result of benign prostatic hyperplasia (BPH) were randomly selected and equally divided into two groups: TURP and PVP. Urodynamic evaluation was performed and International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 and International Consultation on Incontinence Questionnaire - Short Form questionnaires were completed. The results were assessed at 2 years. Mean IPSS scores were reduced in both groups, although they did not differ between the TURP and PVP groups. There was no significant change in International Index of Erectile Function-5 scores. Half of the patients in the PVP group developed urge urinary incontinence with spontaneous resolution. The urodynamic parameters analyzed showed an improvement for both groups, although the values in the TURP group values were not significantly different from those in the PVP group. Bladder storage symptoms may represent a major concern, although they are of limited duration in patients undergoing PVP. High-power PVP can achieve and maintain the same results as TURP over a period of 24 months.

Pereira-Correia JA ，de Moraes Sousa KD ，Santos JB ，de Morais Perpétuo D ，Lopes-da-Silva LF ，Krambeck RL ，Muller VJ ，Vaz FP ... -  《-》

A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study.

The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Qmax, prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Qmax, and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1(st) yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement.

Thomas JA ，Tubaro A ，Barber N ，d'Ancona F ，Muir G ，Witzsch U ，Grimm MO ，Benejam J ，Stolzenburg JU ，Riddick A ，Pahernik S ，Roelink H ，Ameye F ，Saussine C ，Bruyère F ，Loidl W ，Larner T ，Gogoi NK ，Hindley R ，Muschter R ，Thorpe A ，Shrotri N ，Graham S ，Hamann M ，Miller K ，Schostak M ，Capitán C ，Knispel H ，Bachmann A ... -  《-》