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The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.
The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects.
Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UroLift System | Active Comparator | UroLift System procedure |
|
| Transurethral Resection of the Prostate | Active Comparator | Transurethral Resection of the Prostate surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroLift System | Device | The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met |
| Month 12 |
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Inclusion Criteria:
• Men >50 years old with moderate-severe BPH
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Montorsi, MD | University Vita Salute San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Denmark | ||||
| PAN Klinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25937539 | Derived | Sonksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | UroLift System | UroLift System procedure UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. |
| FG001 | Transurethral Resection of the Prostate | Transurethral Resection of the Prostate surgery Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UroLift System | UroLift System procedure UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met |
| Posted | Number | % Responders of Participants | Month 12 |
|
SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UroLift System | UroLift System procedure UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weak urinary stream | Gastrointestinal disorders | Meddra version 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder spasm | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | NeoTract | 925-401-0641 | ehergenreter@neotract.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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|
| Transurethral Resection of the Prostate | Procedure | Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck. |
|
| Cologne |
| 50667 |
| Germany |
| University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Ludwigs-Maximilians Universität / Klinikum Großhadern | Munich | 81377 | Germany |
| University Hospital Tuebingen | Tübingen | Germany |
| Frimley Park Hospital | Frimley | GU16 7UJ | United Kingdom |
| The Royal Hallamshire Hospital | Sheffield | United Kingdom |
| City Hospitals Sunderland NHS Foundation Trust | Sunderland | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| BG001 | Transurethral Resection of the Prostate | Transurethral Resection of the Prostate surgery Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Transurethral Resection of the Prostate | Transurethral Resection of the Prostate surgery Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck. |
|
|
| 2 |
| 45 |
| 33 |
| 45 |
| EG001 | Transurethral Resection of the Prostate | Transurethral Resection of the Prostate surgery Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck. | 4 | 35 | 28 | 35 |
| Blood clot in urine | Gastrointestinal disorders | Meddra | Systematic Assessment |
|
| Urge incontinence | Gastrointestinal disorders | meddra | Systematic Assessment |
|
| Urethral Stricture | Gastrointestinal disorders | Meddra | Systematic Assessment |
|
| Epididymitis | Gastrointestinal disorders | Meddra | Systematic Assessment |
|
| Incomplete Bladder Empyting | Gastrointestinal disorders | Meddra | Systematic Assessment |
|
| Bladder Tamponade | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Blood clot in urine | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysuria | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Epidymitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erectile Dysfunction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hemaeturia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Incomplete bladder empyting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Infection , urinary tract | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lower urinary tract symptoms | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nocturia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain, Abdominal | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain, Groin | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pelvic Pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Post-void dribble | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Prostatic greenlight laser vaporization | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Prosthesis calcification | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Residual urine volume increase | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Retrograde Ejaculation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Stone, urinary bladder | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Urge Incontinence | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Urinary Frequency | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Urinary urgency | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Weak urinary stream | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
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| D052801 |
| Male Urogenital Diseases |
| D013514 | Surgical Procedures, Operative |