A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization (PVP)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)|
- Percentage of Participants With Treatment Success [ Time Frame: 6 months ] [ Designated as safety issue: No ]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%
- Treatment-related Complication [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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
- Percentage of Participants With Clinically-significant Improvement in Uroflow. [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: Yes ]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
- Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume. [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: Yes ]A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.
- Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Gross Hematuria [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
- Percentage of Participants With Treatment Success [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]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.
- Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity. [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
- Occurrence of Retrograde Ejaculation [ Time Frame: 5 Year Follow Up ] [ Designated as safety issue: Yes ]Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.
- Length of Hospital Stay (LOS) [ Time Frame: Peri-Operative Period ] [ Designated as safety issue: No ]Defined as the time from admission to the healthcare facility until discharge (in hours).
- Length of Catheterization (LOC) [ Time Frame: Recovery Period ] [ Designated as safety issue: No ]Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).
- Length of Procedure (LOP) [ Time Frame: Procedure ] [ Designated as safety issue: No ]Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).
- Length of Lasing (LOL) [ Time Frame: Procedure ] [ Designated as safety issue: No ]Total time the laser was on during the study procedure.
- Number of Fibers Used During Procedure [ Time Frame: Procedure ] [ Designated as safety issue: No ]
- Total Joules Used [ Time Frame: Procedure ] [ Designated as safety issue: No ]Total energy applied during the study procedure
|Study Start Date:||May 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Device: GreenLight HPS
Greenlight HPS laser system for treatment of BPH
Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having to urinate very often, a sudden strong feeling of having to urinate, having to get up at night to urinate, decreased and intermittent force of stream and the feeling of incomplete bladder emptying. These symptoms affect quality of life by interfering with normal daily activities and sleep patterns. When surgery is the best treatment option for the patient, the most common technique is a "transurethral resection of the prostate" (TURP). TURP involves removing the some of the extra tissue of the prostate gland. Even though TURP is a good treatment, there are concerns about the frequency of complications following treatment as well as the significant costs to patients, doctors, and insurance providers.
Photoselective vaporization of the prostate (PVP) is a relatively new technology that has similar benefits with fewer side effects than TURP. PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area. This technology has been used for more than a decade with over 200,000 procedures performed worldwide.
The focus of this study is to 1) document the long-term advantages of GreenLight HPS 120w and 2) to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time, may be done in an out-patient setting in healthy patients, allows for shorter catheterization time, may result in a rapid urinary flow rate with minimal side effects, and may allow a quick return to normal activities. This device has been approved by the United States Food and Drug Administration (FDA) for treatment of obstructive BPH.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465101
|United States, California|
|Los Angeles, California, United States, 90095|
|United States, Connecticut|
|Connecticut Clinical Reseach Center|
|Middlebury, Connecticut, United States, 06762|
|United States, Georgia|
|North Fulton Urology, P.C.|
|Roswell, Georgia, United States, 30076|
|United States, Michigan|
|Affiliates in Urology|
|Detroit, Michigan, United States, 48186|
|United States, New York|
|PC Group/Universtiy Urology Association|
|New York, New York, United States, 10016|
|United States, Ohio|
|Glickman Urological Institute|
|Cleveland, Ohio, United States, 44195|
|United States, Oklahoma|
|Oklahoma University Health Science Center_Urology|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|UT Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390-9110|
|United States, Virginia|
|Urology of Virginia|
|Virginia Beach, Virginia, United States, 23454|
|Principal Investigator:||Claus G Roehrborn, MD||UT Southwestern Medical Center at Dallas|