NCT00461123

Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy

A Randomized, Double-blind, Parallel Group Prospective Pilot Study to Assess the Effect of Vardenafil on Clinical Outcome and on Procedure Duration After Green Light Laser-ablation of the Prostate Gland for Therapy of Benign Prostate Hypertrophy (BPH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.

Conditions

• Prostatic Hypertrophy, Benign

Interventions

Type	Name	Description
DRUG	Vardenafil (Levitra, BAY38-9456)	One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
DRUG	Placebo	One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-04-17
• Last updated: 2014-12-19
• Results posted: 2010-01-21

Locations

1 site across 1 country: Germany