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

BACKGROUND: Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized controlled trial was conducted. INTERVENTION: Patients underwent monopolar TURP or PVP with the GreenLight HPS 120-W laser. MEASUREMENTS: 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. RESULTS AND LIMITATIONS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: NCT01043588.

[Comparison of two methods of local anaesthesia prior to transrectal ultrasound-guided prostate biopsies]. / Comparaison de deux méthodes d'anesthésie locale avant biopsies transrectales echo-guidées de prostate.

OBJECTIVE: To compare the analgesic efficacy of rectal administration of Lidocaïne gel with Lidocaïne periprostatic infiltration prior to transrectal ultrasound-guided prostate biopsies. MATERIAL AND METHODS: Between July 2002 and July 2003, candidates to prostate biopsies were randomised into two groups. In group 1, 15 ml 2% Lidocaïne gel was administered intra-rectally 10 minutes prior to biopsies and patients included in group 2 received 10 ml of 1% Lidocaïne in two périprostatique equivalent injections, 4 minutes prior to prostate biopsies. Pain was assessed with a Visual Analog Scale, during anaesthesia (VAS 1), during the biopsies procedure (VAS 2) and 30 minutes after them (VAS 3). RESULTS: 308 patients were included in this trial with 156 patients in group 1 and 152 in group 2. Group 1 experienced statistically less pain for VAS 1 (0.1 versus 1.4, p < 0.0001) and VAS 3 (0.8 versus 1.4, p < 0.001) but no significative difference could be demonstrated for VAS 2 (1.8 versus 2.0). No major complication was noted. CONCLUSION: Rectal administration of Lidocaïne gel and infiltration of Lidocaïne lead to a comparable level of anaesthesia during prostatic biopsies procedure. However, the Lidocaïne gel, being both safe and simple, tends to maintain a better comfort of the patient 30 minutes after the end of the biopsies.

Local anesthesia before transrectal ultrasound guided prostate biopsy: comparison of 2 methods in a prospective, randomized clinical trial.

PURPOSE: We compared the analgesic efficacy of the rectal administration of lidocaine gel and lidocaine periprostatic infiltration prior to transrectal ultrasound guided prostatic biopsies. MATERIALS AND METHODS: A total of 328 consecutive men undergoing biopsy were entered into this study. The 166 patients randomized to group 1 received 15 cc 2% lidocaine gel administered intrarectally 10 minutes before prostate biopsy and the 162 in group 2 received 10 cc 1% lidocaine under ultrasound guidance as 2 periprostatic injections of 5 cc 5 minutes prior to biopsy. A self-administered visual analogue scale (VAS) was used to assess the pain score during anesthesia (VAS 1), during biopsy (VAS 2) and 30 minutes later (VAS 3). RESULTS: The patients in group 1 experienced statistically less pain than those in group 2 for mean VAS 1 (0.1 vs 1.4, p <0.0001) and mean VAS 3 (0.8 vs 1.4, p <0.001) but no statistically significant difference was noted for mean VAS 2 (2.0 vs 2.6, p = 0.04). No major morbidity was reported with either anesthesia. CONCLUSIONS: We are quite convinced of the necessity of local anesthesia to decrease pain during transrectal prostate ultrasound guided biopsy. Rectal administration of lidocaine gel is safe, simple and effective even when no difference regarding pain is noted vs lidocaine periprostatic infiltration during the biopsy procedure.