Trial Outcomes & Findings for A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization (NCT NCT00465101)

Last Updated: 2015-10-28

Results Overview

Treatment success is determined on a per patient basis and is defined as \[(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS\] greater than or equal to 50%

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

6 months

Results posted on

2015-10-28

Participant Flow

This study enrolled patients at least 45 years of age with symptomatic/obstructive BPH for at least 3 months and requiring surgical intervention. Enrollment occurred at 10 academic and private medical centers in the US. The last patient follow up visit was completed in August 2012. The last site close-out visit was completed January 2013.

Participant milestones

Participant milestones
Measure	GreenLight HPS Laser System GreenLight HPS Laser System therapy for patients with BPH.
Overall Study STARTED	150
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	59

Reasons for withdrawal

Reasons for withdrawal
Measure	GreenLight HPS Laser System GreenLight HPS Laser System therapy for patients with BPH.
Overall Study Aborted Proc./Treatment Not Attempted	3
Overall Study Change in health precluded follow up	4
Overall Study Did not meet study criteria	4
Overall Study Lost to Follow-up	5
Overall Study Other	6
Overall Study Pt. Insurance not accepted at center	2
Overall Study Patient postponed procedure	1
Overall Study Site closed due to IRB expiration	1
Overall Study Unable to obtain IRB approval	1
Overall Study Death	3
Overall Study Withdrawal by Subject	25
Overall Study Physician Decision	1
Overall Study Withdrew consent prior to procedure	3

Baseline Characteristics

A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GreenLight HPS Laser System n=150 Participants GreenLight HPS Laser System therapy for patients with BPH.
Age, Continuous	66.3 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants
Height (cm)	178.5 cm STANDARD_DEVIATION 7.0 • n=5 Participants
Weight (kg)	87.3 kg STANDARD_DEVIATION 14.8 • n=5 Participants
Smoker	10 participants n=5 Participants
Previous BPH Treatment	134 participants n=5 Participants
Average Duration of Obstructive Symptoms (months)	74.9 months STANDARD_DEVIATION 60.2 • n=5 Participants
Peak Flow Rate (ml/sec)	10.7 ml/sec STANDARD_DEVIATION 5.4 • n=5 Participants
Post-void Residual Volume (ml)	112.5 ml STANDARD_DEVIATION 115.5 • n=5 Participants
Serum Prostate Specific Antigen (PSA) level (ng/ml)	2.5 ng/ml STANDARD_DEVIATION 2.1 • n=5 Participants
Prostate Volume (cc)	58.5 cc STANDARD_DEVIATION 28.4 • n=5 Participants
International Prostate Symptom Score (IPSS) at Baseline	22.9 Scores on a scale STANDARD_DEVIATION 5.8 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who received the study treatment and for whom the outcome measure is available.

Treatment success is determined on a per patient basis and is defined as \[(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS\] greater than or equal to 50%

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=119 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Percentage of Participants With Treatment Success	84.9 percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Participants who received the study treatment.

Treatment-related events include the following: * Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization * Perforation / injury of adjacent organ(s) * Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal * Hematuria requiring transfusion * Urinary retention requiring corrective intervention * De novo erectile dysfuction (ED) * Transfusion secondary to procedure-related anemia * Post procedure incontinence secondary to damage to the external urinary sphincter * Any other treatment-related injury requiring intervention

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=135 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Treatment-related Complication	11.1 percentage of subjects with complication Interval 6.5 to 17.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months post-treatment

Population: Participants who received the study treatment and for whom the outcome measure is available.

A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=117 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Percentage of Participants With Clinically-significant Improvement in Uroflow.	70.9 percentage of patients improved Interval 61.8 to 79.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months post-treatment

Population: Participants who received the study treatment and for whom the outcome measure is available.

A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=117 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.	42.7 percentage of patients improved Interval 33.6 to 52.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 years

Population: Participants who received the study treatment and for whom the outcome measure is available.

Participant response to the question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Values range from 0 ("Delighted") to 6 ("Terrible") with higher values indicating worse outcomes.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=136 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months n=131 Participants	6 Months n=119 Participants	1 Year n=117 Participants	2 Years n=103 Participants	3 Years n=97 Participants	4 Years n=59 Participants	5 Years n=4 Participants
Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.	4.4 Score on a scale Standard Deviation 1.1	1.6 Score on a scale Standard Deviation 1.4	1.3 Score on a scale Standard Deviation 1.2	1.3 Score on a scale Standard Deviation 1.2	1.3 Score on a scale Standard Deviation 1.2	1.3 Score on a scale Standard Deviation 1.3	1.2 Score on a scale Standard Deviation 1.2	0.8 Score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 91 days

Population: Participants who received the study treatment

Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=136 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months n=136 Participants	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Gross Hematuria	1.5 Percentage of subjects	2.2 Percentage of subjects	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 Years

Population: Participants who received the study treatment and for whom the outcome measure is available.

Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=136 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months n=131 Participants	6 Months n=119 Participants	1 Year n=117 Participants	2 Years n=103 Participants	3 Years n=97 Participants	4 Years n=59 Participants	5 Years n=4 Participants
Percentage of Participants With Treatment Success	0 Percent of subjects w/ treatment success Interval 0.0 to 0.0	72.5 Percent of subjects w/ treatment success Interval 64.0 to 80.0	84.9 Percent of subjects w/ treatment success Interval 77.2 to 90.8	77.8 Percent of subjects w/ treatment success Interval 69.2 to 84.9	79.6 Percent of subjects w/ treatment success Interval 70.5 to 86.9	75.3 Percent of subjects w/ treatment success Interval 65.5 to 83.5	74.6 Percent of subjects w/ treatment success Interval 61.6 to 85.0	100.0 Percent of subjects w/ treatment success Interval 39.8 to 100.0

SECONDARY outcome

Timeframe: Up to five years

Population: Participants who received the study treatment and for whom the outcome measure is available.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=126 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.	9.5 days Standard Deviation 9.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 Year Follow Up

Population: Participants who received the study treatment

Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=136 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Occurrence of Retrograde Ejaculation	43.3 percentage of subjects with RE Interval 34.1 to 52.0	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Peri-Operative Period

Population: Participants who received the study treatment and for whom the outcome measure is available.

Defined as the time from admission to the healthcare facility until discharge (in hours).

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=135 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Length of Hospital Stay (LOS)	5.2 hours Standard Deviation 7.1	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Recovery Period

Population: Participants who received the study treatment and for whom the outcome measure is available.

Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=124 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Length of Catheterization (LOC)	21.9 hours Standard Deviation 22.9	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Procedure

Population: Participants who received the study treatment and for whom the outcome measure is available.

Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=136 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Length of Procedure (LOP)	53.9 minutes Standard Deviation 21.5	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Procedure

Population: Participants who received the study treatment and for whom the outcome measure is available.

Total time the laser was on during the study procedure.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=135 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Length of Lasing (LOL)	34.1 minutes Standard Deviation 17.5	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Procedure

Population: Participants who received the study treatment and for whom the outcome is available.

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=136 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Number of Fibers Used During Procedure	1.2 number of fibers used Standard Deviation 0.5	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Procedure

Population: Participants who received the study treatment and for whom the outcome measure is available.

Total energy applied during the study procedure

Outcome measures

Outcome measures
Measure	GreenLight HPS Laser System n=135 Participants GreenLight HPS Laser System therapy for patients with BPH.	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Total Joules Used	190.6 kilojoules (kJ) Standard Deviation 94.4	—	—	—	—	—	—	—

Adverse Events

GreenLight HPS Laser System

Serious events: 35 serious events

Other events: 97 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GreenLight HPS Laser System n=136 participants at risk GreenLight HPS Laser System therapy for patients with BPH.
General disorders Allergic Reaction / Hypersensitivity	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Infections and infestations Infection (other than UTI)	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Perforation - Prostate	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Injury - Other	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Musculoskeletal and connective tissue disorders Pain / Discomfort - Leg	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Pain / Discomfort - Other	2.9% 4/136 • Number of events 4 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Bladder Neck Contracture / Outlet Obstruct	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Hematuria - Gross	0.74% 1/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Retention	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Vascular disorders Deep Venous Thrombosis	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Other: Death	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Prostate Cancer	2.2% 3/136 • Number of events 3 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Renal Failure - Acute	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Cardiac disorders Other: Atrial Arrhythmia	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Musculoskeletal and connective tissue disorders Other: Hernia	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Blood and lymphatic system disorders Other: Lymphoma	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Cardiac disorders Other: Cardiomyopathy	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Vascular disorders Other: Coronary Artery Disease	1.5% 2/136 • Number of events 3 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Musculoskeletal and connective tissue disorders Other: Multiple Myeloma	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Musculoskeletal and connective tissue disorders Other: Rotator Cuff Tear	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Respiratory, thoracic and mediastinal disorders Other: Sleep Apnea	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Blood and lymphatic system disorders Other: Epistaxis	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Vascular disorders Other: Stroke	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Musculoskeletal and connective tissue disorders Other: Knee Replacement	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Metabolism and nutrition disorders Other: Obesity - Worsening	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Other	3.7% 5/136 • Number of events 8 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).

Other adverse events

Other adverse events
Measure	GreenLight HPS Laser System n=136 participants at risk GreenLight HPS Laser System therapy for patients with BPH.
Renal and urinary disorders Dysuria	22.1% 30/136 • Number of events 31 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Retrograde Ejaculation - De Novo	22.1% 30/136 • Number of events 30 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Urgency	17.6% 24/136 • Number of events 24 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Retrograde Ejaculation	16.9% 23/136 • Number of events 23 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Frequency	10.3% 14/136 • Number of events 15 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Tract Infection (UTI)	6.6% 9/136 • Number of events 9 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Hematuria	11.0% 15/136 • Number of events 15 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Hematuria - Gross	6.6% 9/136 • Number of events 10 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Erectile Dysfunction - De Novo	5.9% 8/136 • Number of events 8 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Incontinence - De Novo	7.4% 10/136 • Number of events 10 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Pain / Discomfort - Other	4.4% 6/136 • Number of events 6 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Allergic Reaction / Hypersensitivity Reaction	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Bladder Neck Contracture / Outlet Obstruct	2.9% 4/136 • Number of events 6 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Prostatitis	3.7% 5/136 • Number of events 5 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Retention - Acute	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Gastrointestinal disorders Nausea	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urinary Retention	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Erectile Dysfunction - Worsening	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Perforation - Prostate	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Sloughing	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Urethral Stricture	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Gastrointestinal disorders Vomiting	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Nocturia	2.9% 4/136 • Number of events 4 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Urinary Dribbling	4.4% 6/136 • Number of events 7 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Cardiac disorders Other: Hypertension	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Bladder Spasm	2.2% 3/136 • Number of events 3 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Lack of Sensation During Ejaculation	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Overactive Bladder	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Skin and subcutaneous tissue disorders Other: Paraphimosis	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Urethral Burning at Foley Catheter Site	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Urine Flow Decreased Force	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Bladder Pressure	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Clot Retention	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Renal and urinary disorders Other: Decrease Sense of Emptying Bladder	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Reproductive system and breast disorders Other: Sexual Dysfunction	0.74% 1/136 • Number of events 1 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
General disorders Other	1.5% 2/136 • Number of events 2 • Through study completion; planned to be 5 years. All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).

Additional Information

Mara M. LaRock, Senior Manager, Clinical Franchise Lead

American Medical Systems

Phone: 952-930-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place