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)

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 Overview

• Status: Completed
• Conditions: Prostatic Hypertrophy, Benign
• Intervention / Treatment: Drug: Vardenafil (Levitra, BAY38-9456); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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: 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.
PLACEBO_COMPARATOR: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here and search for Bayer Product information by EMA

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: April 16, 2007
• First Submitted That Met QC Criteria: April 16, 2007
• First Posted (ESTIMATE): April 17, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride
• Other Study ID Numbers: 12496; 2006-004633-15 (EUDRACT_NUMBER)