BPH, Prostate Hyperplasia, Urinary Frequency/Urgency
Conditions
Keywords
BPH, Benign Prostatic Hypertrophy, MRI, Prostate, Lower Urinary Tract Symptoms, Nocturia, Incomplete bladder emptying
Brief summary
Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.
Interventions
DEVICEMRI Guided Transrectal Periuretheral Transitional Zone Ablation
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Sponsors
Medtronic
Prostate Laser Center, PLLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of lower urinary track symptoms (LUTS). 2. Prostate volume of 40 - 200 cc. 3. Men ≥ 45 years old. 4. IPSS ≥ 15. 5. BPH Impact Index ≥ 5.
Exclusion criteria
1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer. 2. Need to catheterize to relieve obstruction. 3. Daily use of incontinence materials/padding. 4. Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes. 5. Prior interventional or surgical treatment of BPH. 6. Penile prosthesis. 7. Artificial urinary sphincter or collagen bladder injection. 8. Urethral stricture. 9. Bleeding disorder/coagulopathy. 10. Inability to refrain from blood thinners in the peri-procedural period. 11. Inability or chooses not to provide informed consent. 12. Any serious medical condition which would make proceeding to treatment unsafe. 13. Significant contraindication to MRI or gadolinium contrast. 14. Hip replacement. 15. Lack of a rectum. 16. Life expectancy of less than two years. 17. Unable or unwilling to complete all required questionnaires and follow-up assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) Change | From baseline to 2 months | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). |
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | From baseline to 2 months | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 (delighted) to 6 (terrible) |
| BPH Impact Index Change | From baseline to 2 months | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) |
| Sexual Health Inventory of Men (SHIM) Score Change | From baseline to 2 months | This survey rates erectile function from 0 (no function) to 25 (full function) |
| Number of Adverse Events | Continuous until completion of the study at 2 years | We asked patients to self-report adverse events. |
Countries
United States
Participant flow
Recruitment details
All the procedures were performed between May 2017 and May 2018. All procedures were performed at a free-standing magnetic resonance imaging (MRI) center, and pre-procedure and post-procedure visits were completed in an outpatient office.
Participants by arm
| Arm | Count |
|---|---|
| FLA for BPH Active Treatment MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | FLA for BPH Active Treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 6.2 | — |
| Benign Prostatic Hyperplasia (BPH) Impact Index | 9.7 points STANDARD_DEVIATION 1.9 | — |
| International Prostate Symptom Score (IPSS) | 26.3 points STANDARD_DEVIATION 4.96 | — |
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) | 5.1 points STANDARD_DEVIATION 0.83 | — |
| Prostate volume | 69.3 cubic centimeters (cc) STANDARD_DEVIATION 31 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
| Sexual Health Inventory For Men (SHIM) | 20 points STANDARD_DEVIATION 6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Time frame: From baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | BPH Impact Index Change | -7.7 units on a scale | Standard Deviation 2 |
Primary
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Time frame: From baseline to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | BPH Impact Index Change | -6.9 units on a scale | Standard Deviation 2.1 |
Primary
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Time frame: From baseline to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | BPH Impact Index Change | -7.4 units on a scale | Standard Deviation 2.3 |
Primary
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Time frame: From baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | BPH Impact Index Change | -6.7 units on a scale | Standard Deviation 2.3 |
Primary
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Time frame: From baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Change | -17.5 units on a scale | Standard Deviation 4.1 |
Primary
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Time frame: From baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Change | -20.1 units on a scale | Standard Deviation 5.8 |
Primary
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Time frame: From baseline to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Change | -18.4 units on a scale | Standard Deviation 4.2 |
Primary
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Time frame: From baseline to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Change | -17.5 units on a scale | Standard Deviation 4.3 |
Primary
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 (delighted) to 6 (terrible)
Time frame: From baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | -3.7 units on a scale | Standard Deviation 1.3 |
Primary
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 (delighted) to 6 (terrible)
Time frame: From baseline to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | -3.4 units on a scale | Standard Deviation 0.8 |
Primary
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 (delighted) to 6 (terrible)
Time frame: From baseline to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | -3.1 units on a scale | Standard Deviation 1 |
Primary
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 (delighted) to 6 (terrible)
Time frame: From baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | -3.2 units on a scale | Standard Deviation 1.2 |
Primary
Number of Adverse Events
We asked patients to self-report adverse events.
Time frame: Continuous until completion of the study at 2 years
Population: Two patients experienced urinary tract infections, two patients developed retrograde ejaculation, and one patient had urinary retention after foley catheter removal, requiring catheter replacement and maintenance for 1 week. All adverse events were considered mild using the Society of Interventional Radiology Adverse Events Classification System.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | Number of Adverse Events | 4 Participants |
Primary
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Time frame: From baseline to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | Sexual Health Inventory of Men (SHIM) Score Change | 1.9 score on a scale | Standard Deviation 2.7 |
Primary
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Time frame: From baseline to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | Sexual Health Inventory of Men (SHIM) Score Change | 1.1 units on a scale | Standard Deviation 3.1 |
Primary
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Time frame: From baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | Sexual Health Inventory of Men (SHIM) Score Change | 0.8 units on a scale | Standard Deviation 3.3 |
Primary
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Time frame: From baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Focal Laser Ablation (FLA) for BPH Active Treatment | Sexual Health Inventory of Men (SHIM) Score Change | 2.8 units on a scale | Standard Deviation 3.3 |