A clinical trial comparing BiVap (Richard Wolf®) saline vaporization of the prostate vs. Twister^TM Diode Laser System in the treatment of benign prostatic obstruction between prostate volume 90 to 150 ml

Abstract

Introduction To evaluate the efficacy, safety and postoperative outcomes of the BiVap and Twister systems with benign prostatic obstruction (BPO) in prostate volüm between 90–150 ml. Methods In total, we included 131 patients treated with BiVap system (n = 68) and Twister system (n = 63). Postoperative complications including urinary tract infection, transient hematuria, severe dysuria and fever >38° C, urinary incontinence and urethral stricture were also noted. All patients were evaluated at the postoperative 1st, 3rd, 6th and 12th month and preoperative and postoperative values of IPSS score, QoL score, total PSA, IIEF 15, PVR, Qmax and Qave were compared. Results Preoperative demographic characteristics were similar in the 2 groups. There was observed significant improvement for IPSS, Qmax, Qave, PVR, and QoL score by the postoperative first month compared to the preoperative values in both groups. Maximum improvement in the IPSS, Qmax, Qave, QoL score and PVR were achieved at postoperative 6, 3, 12, 3 and 12th months respectively in group 1. In group 2 maximum improvement in the same parameters were achieved at postoperative 6, 3, 6, 6 and 12th months, respectively. Conclusions BiVap and Twister systems are safe, effective, and useful technique, which can be used in the surgical treatment of BPO between 90–150 ml.

Devices and Procedures Regulation in Medical Practice: Is There a Need for More transparency?

“…Karakose 2 and Clements et al 3 through their contribution in this issue of SMJ brought out new advancing techniques and technology to deal with large size prostates causing urinary outflow obstruction. Benign growth of prostate is a common problem in elderly male population and without more research, in particular prevention we are just learning to add more cost to its management.…”