Trial Outcomes & Findings for Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy (NCT NCT00461123)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

baseline and up to 3 months after surgery

Results posted on

2014-12-19

Participant Flow

Enrollment started on 19 March 2007 and the last study visit occurred on 02 June 2008. The study was conducted at one center, a university clinic in Germany.

Number of subjects enrolled, randomized and exposed to at least one dose (safety population): 50. Number of subjects who had undergone surgery, whose type of surgery (Greenlight(TM) laser-ablation) had not changed, energy consumption during surgery reported and who had taken the second dose on the day of surgery (intent-to-treat population): 44

Participant milestones

Participant milestones
Measure	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 GreenlightTM laser ablation of prostate commences.	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 GreenlightTM laser ablation of prostate commences
Overall Study STARTED	25	25
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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 GreenlightTM laser ablation of prostate commences.	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 GreenlightTM laser ablation of prostate commences
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	3	2
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vardenafil (Levitra, BAY38-9456) n=25 Participants 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 GreenlightTM laser ablation of prostate commences.	Placebo n=25 Participants 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 GreenlightTM laser ablation of prostate commences	Total n=50 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 7.5 • n=5 Participants	65.9 years STANDARD_DEVIATION 7.9 • n=7 Participants	65.9 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and up to 3 months after surgery

Population: The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of peak urinary flow; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study, as displayed under Participants Flow.

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.

Outcome measures

Outcome measures
Measure	Vardenafil (Levitra, BAY38-9456) n=19 Participants 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 GreenlightTM laser ablation of prostate commences.	Placebo n=18 Participants 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 GreenlightTM laser ablation of prostate commences
Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF) Day +90 or LOCF mean	23.1 milliliter per second (mL/s) Standard Deviation 10.60	25.7 milliliter per second (mL/s) Standard Deviation 7.90
Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF) baseline mean	8.3 milliliter per second (mL/s) Standard Deviation 4.08	9.4 milliliter per second (mL/s) Standard Deviation 5.69

SECONDARY outcome

Timeframe: baseline and up to 3 months after surgery

Population: The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of International Prostate Symptom Score (IPSS) total score; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study.

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).

Outcome measures

Outcome measures
Measure	Vardenafil (Levitra, BAY38-9456) n=20 Participants 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 GreenlightTM laser ablation of prostate commences.	Placebo n=19 Participants 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 GreenlightTM laser ablation of prostate commences
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 mean	19.1 scores on a scale Standard Deviation 5.92	19.7 scores on a scale Standard Deviation 5.83
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) Day +90 or LOCF mean	6.9 scores on a scale Standard Deviation 4.25	6.7 scores on a scale Standard Deviation 6.03

SECONDARY outcome

Timeframe: baseline and up to 3 months after surgery

Population: The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of post-void residual (PVR) volume; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study.

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.

Outcome measures

Outcome measures
Measure	Vardenafil (Levitra, BAY38-9456) n=18 Participants 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 GreenlightTM laser ablation of prostate commences.	Placebo n=17 Participants 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 GreenlightTM laser ablation of prostate commences
Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF) baseline mean	139.3 milliliter (mL) Standard Deviation 116.43	117.4 milliliter (mL) Standard Deviation 81.42
Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF) Day +90 or LOCF mean	18.7 milliliter (mL) Standard Deviation 23.55	22.5 milliliter (mL) Standard Deviation 18.34

SECONDARY outcome

Timeframe: baseline and up to 3 months after surgery

Population: The intent-to-treat (ITT) population includes participants with baseline and post-baseline documentation of number of incontinence episodes per week; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study.

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.

Outcome measures

Outcome measures
Measure	Vardenafil (Levitra, BAY38-9456) n=17 Participants 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 GreenlightTM laser ablation of prostate commences.	Placebo n=18 Participants 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 GreenlightTM laser ablation of prostate commences
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 mean	8.4 urinary incontinence episodes Standard Deviation 25.71	0.0 urinary incontinence episodes Standard Deviation 0.00
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) Day +90 or LOCF mean	7.1 urinary incontinence episodes Standard Deviation 13.42	0.4 urinary incontinence episodes Standard Deviation 1.42

SECONDARY outcome

Timeframe: on the day of surgery, without any further allowable time window

Population: The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of duration of surgery; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study.

Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.

Outcome measures

Outcome measures
Measure	Vardenafil (Levitra, BAY38-9456) n=23 Participants 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 GreenlightTM laser ablation of prostate commences.	Placebo n=21 Participants 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 GreenlightTM laser ablation of prostate commences
Duration of Surgery	75.1 minutes Standard Deviation 36.5	72.5 minutes Standard Deviation 25.8

Adverse Events

Vardenafil (Levitra, BAY38-9456)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vardenafil (Levitra, BAY38-9456) n=25 participants at risk 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 GreenlightTM laser ablation of prostate commences.	Placebo n=25 participants at risk 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 GreenlightTM laser ablation of prostate commences
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/25	4.0% 1/25
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	4.0% 1/25	0.00% 0/25
Renal and urinary disorders Urinary retention	0.00% 0/25	4.0% 1/25

Other adverse events

Other adverse events
Measure	Vardenafil (Levitra, BAY38-9456) n=25 participants at risk 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 GreenlightTM laser ablation of prostate commences.	Placebo n=25 participants at risk 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 GreenlightTM laser ablation of prostate commences
General disorders Pyrexia	4.0% 1/25	0.00% 0/25
Infections and infestations Urinary tract infection	0.00% 0/25	4.0% 1/25
Renal and urinary disorders Urinary retention	0.00% 0/25	4.0% 1/25
Vascular disorders Flushing	4.0% 1/25	0.00% 0/25

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place