BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
NCT ID: NCT01533038
Last Updated: 2017-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2012-02-29
2016-01-31
Brief Summary
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Detailed Description
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Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Other medical condition or co-morbidity contraindicative for TURP or UroLift
50 Years
MALE
No
Sponsors
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NeoTract, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Francesco Montorsi, MD
Role: PRINCIPAL_INVESTIGATOR
University Vita Salute San Raffaele
Locations
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Herlev Hospital
Herlev, , Denmark
PAN Klinik
Cologne, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
Ludwigs-Maximilians Universität / Klinikum Großhadern
Munich, , Germany
University Hospital Tuebingen
Tübingen, , Germany
Frimley Park Hospital
Frimley, , United Kingdom
The Royal Hallamshire Hospital
Sheffield, , United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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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.
Other Identifiers
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CP12317
Identifier Type: -
Identifier Source: org_study_id