Prostatic Urethral Lift in Subject With Acute Urinary Retention
NCT ID: NCT03194737
Last Updated: 2021-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2018-03-24
2020-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UroLift System procedure
All eligible,enroled subjects will undergo a UroLift procedure.
UroLift System Procedure
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Retrospective Arm
Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015
No interventions assigned to this group
Interventions
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UroLift System Procedure
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of symptomatic BPH
3. Age ≥ 50 years
4. Prostate volume ≤ 100 cc per ultrasound (US)
5. Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
Exclusion Criteria
2. Previous BPH surgical procedure
3. Previous pelvic surgery
4. Urethral conditions that prevents insertion and delivery of device system into bladder
5. Retention volume of \>1500 mL
6. Has not had prostate cancer excluded
7. History of prostate or bladder cancer
8. Biopsy of the prostate within the 6 weeks prior to Index Procedure
9. History of neurogenic or atonic bladder
10. Acute or chronic renal failure
11. Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
12. Known bladder stones within the prior 3 months or treatment within 12 months
13. Prostatitis requiring treatment (antibiotics) within the last year
14. Other co-morbidities that could impact the study results
* severe cardiac arrhythmias uncontrolled by medications or pacemaker
* congestive heart failure New York Heart Association (NYHA) III or IV
* history of uncontrolled diabetes mellitus
* significant respiratory disease in which hospitalisation may be required
* known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
15. Life expectancy estimated to be less than 5 years
16. Desire to maintain fertility post procedure
17. Unable or unwilling to complete all required questionnaires and follow up assessments
18. Unable or unwilling to sign informed consent form
19. Currently enroled in any other clinical research trial that has not completed the primary endpoint
50 Years
MALE
No
Sponsors
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NeoTract, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Barber
Role: PRINCIPAL_INVESTIGATOR
Frimley Park Hospital
Oliver Kayes
Role: PRINCIPAL_INVESTIGATOR
St James's University Hosptial
Mark Rochester
Role: PRINCIPAL_INVESTIGATOR
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Toby Page
Role: PRINCIPAL_INVESTIGATOR
Freeman Health System
Rajesh Kavia
Role: PRINCIPAL_INVESTIGATOR
Central Middlesex Hospital
Nikesh Thiruchelvam
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospitals NHS Foundation Trust
Locations
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Freeman Hospital
High Heaton, Newcastle Upon Tyne, United Kingdom
Frimley Park Hospital
Frimley, Surrey, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
St. James's University Hospital
Leeds, , United Kingdom
Central Middlesex Hospital
London, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CP00004
Identifier Type: -
Identifier Source: org_study_id
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