NCT01218672

Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH

A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH).

Detailed description

The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to TURP.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Photoselective Vaporization of the Prostate	GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin. GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator.
DEVICE	Transurethral Resection of the Prostate	Monopolar and bipolar loop TURP Systems The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2010-10-11
• Last updated: 2020-09-03
• Results posted: 2020-09-03

Locations

29 sites across 9 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom