Phase 4
N=150
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00465101 ↗Enrolled (actual)
150
Serious AEs
25.7%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Participants With Treatment Success — 84.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- GreenLight HPS (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- American Medical Systems
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Success |
0; 72.5; 84.9; 77.8; 79.6; 75.3 | — |
| SECONDARY Treatment-related Complication |
11.1 | — |
| SECONDARY Percentage of Participants With Clinically-significant Improvement in Uroflow. |
70.9 | — |
| SECONDARY Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume. |
42.7 | — |
| SECONDARY Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. |
4.4; 1.6; 1.3; 1.3; 1.3; 1.3 | — |
| SECONDARY Gross Hematuria |
1.5; 2.2 | — |
| SECONDARY Percentage of Participants With Treatment Success |
0; 72.5; 84.9; 77.8; 79.6; 75.3 | — |
| SECONDARY Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity. |
9.5 | — |
| SECONDARY Occurrence of Retrograde Ejaculation |
43.3 | — |
Summary
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
Eligibility Criteria
Inclusion Criteria
- All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score >14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study
Exclusion Criteria
- American Society of Anesthesiologists (ASA) classification of physical status > III
- An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods
- A myocardial infarction or coronary artery stent placement within 6 months of the treatment
- Neurogenic lower urinary dysfunction
- A post-void residual (PVR) volume ≥ 400 mL
- Pre-existing urinary incontinence
- Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function
- Pre-existing damage of external urinary sphincter
- Presence of cystolithiasis, urethral stricture, or bladder neck contracture
- Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc
- Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated
- Immunocompromised subjects
- Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease
- Desire to preserve antegrade ejaculation
- Calcification of prostate tissue, usually after severe prostatitis
- Deemed unfit for laser vaporization as determined by the attending physician
- Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements
Data sourced from ClinicalTrials.gov (NCT00465101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.