Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
enlarged prostate
Brief summary
This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.
Interventions
DEVICEGreenlight XPS Laser
Treatment of BPH with Greenlight XPS laser
DEVICEBiVAP Saline Vaporization of the prostate
treatment of BPH with BiVAP Saline Vaporization
Sponsors
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
Brooklyn Urology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male over the age of 18 years * present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention * subjects must read, understand and sign the Informed Consent * AUA ≥ 15 * Qmax \< 15mL/sec * Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months * Prostate volume ≥ 30g
Exclusion criteria
* PVR \> 300ml * Current urine retention * Previous surgical or invasive treatments (TURP, TUMT, TUNA) * PSA ≥ 4 (must have negative biopsy within last 12 months) * Neurogenic bladder * Obstruction due to urethral stricture * Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in American Urological Association Symptom Score | Baseline and 12 months | The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms |
| Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax) | baseline and 12 months | maximum urinary flow rate was measures using uroflow device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Months in Post Void Residual Volume | baseline and 12 months | post void residual was measured using a bladder scan device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Greenlight XPS Laser Greenlight XPS Laser of the prostate
Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser | 31 |
| BiVAP Saline Vaporization BiVAP Saline Vaporization of the prostate
BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization | 35 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
Baseline characteristics
| Characteristic | Greenlight XPS Laser | BiVAP Saline Vaporization | Total |
|---|---|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 8.1 | 65.5 years STANDARD_DEVIATION 10 | 67.4 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 31 Participants | 35 Participants | 66 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 31 Participants | 35 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 35 |
| other Total, other adverse events | 2 / 31 | 4 / 35 |
| serious Total, serious adverse events | 0 / 31 | 0 / 35 |
Outcome results
Primary
Change From Baseline in American Urological Association Symptom Score
The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms
Time frame: Baseline and 12 months
Population: All people who completed the study and had data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greenlight XPS Laser | Change From Baseline in American Urological Association Symptom Score | -14.7 units on a scale | Standard Deviation 9 |
| BiVAP Saline Vaporization | Change From Baseline in American Urological Association Symptom Score | -10.5 units on a scale | Standard Deviation 8.6 |
Primary
Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)
maximum urinary flow rate was measures using uroflow device
Time frame: baseline and 12 months
Population: all participants who completed the study and have available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greenlight XPS Laser | Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax) | 5.9 ml/sec | Standard Deviation 8.6 |
| BiVAP Saline Vaporization | Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax) | 2.3 ml/sec | Standard Deviation 8.3 |
Secondary
Change From Baseline to 12 Months in Post Void Residual Volume
post void residual was measured using a bladder scan device
Time frame: baseline and 12 months
Population: all participants who completed the study and have available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Greenlight XPS Laser | Change From Baseline to 12 Months in Post Void Residual Volume | -61.9 ml | Standard Deviation 104 |
| BiVAP Saline Vaporization | Change From Baseline to 12 Months in Post Void Residual Volume | -36.7 ml | Standard Deviation 122.2 |