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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Prostatic Hypertrophy, Benign

Intervention / Treatment
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* Drug: Vardenafil (Levitra, BAY38-9456)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with benign prostate hypertrophy requiring surgical treatment Age up to 80 years Documented, dated, written Informed Consent Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery Exclusion Criteria: Any unstable medical, psychiatric, or substance abuse disorder History of previous prostatectomy Patients suspect of prostate cancer Hereditary degenerative retinal disorder History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment Any cardiovascular condition History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months Uncontrolled atrial fibrillation/flutter at screening Severe chronic or acute liver disease Chronic hematological disease which may lead to priapism Bleeding disorder Significant active peptic ulceration Resting hypotension History of positive test for Hepatitis B surface antigen or Hepatitis C Symptomatic postural hypotension within 6 months of Visit 1 Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well Subjects who are taking nitrates or nitric oxide donors Subjects who are taking androgens or anti-androgens Subjects who are taking potent inhibitors of cytochrome P4503A4 Subjects who have received any investigational drug within 30 days of Visit 1 Using of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate Use of inhibitors of 5-alpha reductase after ablation of prostate Subjects with serum creatinine clearance <30.0 mL/min Elevation of Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >3 times the upper limit of normal Subjects with known hypersensitivity to Vardenafil Subjects who are illiterate or unable to understand subject diaries Subjects who would be non-compliant with the study visit schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vardenafil (Levitra, BAY38-9456)<br>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: Vardenafil (Levitra, BAY38-9456)<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow. | baseline and up to 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst). | baseline and up to 3 months after surgery | 
| Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine. | baseline and up to 3 months after surgery | 
| Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary. | baseline and up to 3 months after surgery | 
| Duration of Surgery | Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery. | on the day of surgery, without any further allowable time window |