At a glance
ClinicalIndex Comparison Record- ✓Men with benign prostate hypertrophy requiring surgical treatment
- ✓Age up to 80 years
- ✓Documented, dated, written Informed Consent
- ✓Able to swallow 1 tablet one hour prior surgery per anesthesiologist agreement
- ✕Any unstable medical, psychiatric, or substance abuse disorder
- ✕History of previous prostatectomy
- ✕Patients suspect of prostate cancer
- ✕Hereditary degenerative retinal disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Vardenafil (Levitra, BAY38-9456) and Placebo for Prostatic Hypertrophy, Benign. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.