Clinical trial NCT00461123: Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Hypertrophy, Benign
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
timeFrame: baseline and up to 3 months after surgery
Secondary outcomes:
measure: 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)
timeFrame: baseline and up to 3 months after surgery
measure: Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
timeFrame: baseline and up to 3 months after surgery
measure: 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)
timeFrame: baseline and up to 3 months after surgery
measure: Duration of Surgery
timeFrame: on the day of surgery, without any further allowable time window
Other outcomes:
Locations:
city: Heidelberg
country: Germany
state: Baden-Württemberg
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: