Back to resultsProstatic Urethral Lift in Subject With Acute Urinary Retention
Primary Purpose
Acute Urinary Retention, Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
UroLift System Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Acute Urinary Retention focused on measuring Benign prostatic hyperplasia, BPH, Urinary retention, prostate, hypertrophy
Eligibility Criteria
UroLift System Procedure Arm
Inclusion Criteria:
- Male gender
- Diagnosis of symptomatic BPH
- Age ≥ 50 years
- Prostate volume ≤ 100 cc per ultrasound (US)
- Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
Exclusion Criteria:
- An obstructive or protruding median lobe of the prostate
- Previous BPH surgical procedure
- Previous pelvic surgery
- Urethral conditions that prevents insertion and delivery of device system into bladder
- Retention volume of >1500 mL
- Has not had prostate cancer excluded
- History of prostate or bladder cancer
- Biopsy of the prostate within the 6 weeks prior to Index Procedure
- History of neurogenic or atonic bladder
- Acute or chronic renal failure
- Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
- Known bladder stones within the prior 3 months or treatment within 12 months
- Prostatitis requiring treatment (antibiotics) within the last year
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)
- Life expectancy estimated to be less than 5 years
- Desire to maintain fertility post procedure
- Unable or unwilling to complete all required questionnaires and follow up assessments
- Unable or unwilling to sign informed consent form
- Currently enroled in any other clinical research trial that has not completed the primary endpoint
Sites / Locations
- Freeman Hospital
- Frimley Park Hospital
- Addenbrooke's Hospital
- St. James's University Hospital
- Central Middlesex Hospital
- Norfolk and Norwich University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
UroLift System procedure
Retrospective Arm
Arm Description
All eligible,enroled subjects will undergo a UroLift procedure.
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
Outcomes
Primary Outcome Measures
Successful Trial Without Catheter Peri-procedurally
Success is defined as a spontaneous voided volume of ≥100 mL associated with a post void residual volume by ultrasound <300 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation.
Secondary Outcome Measures
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03194737
Brief Title
Prostatic Urethral Lift in Subject With Acute Urinary Retention
Official Title
Prostatic Urethral Lift in Subject With Acute Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 24, 2018 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
March 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoTract, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
Detailed Description
The study is a multi-centre, prospective evaluation of PUL and retrospective review of invasive surgery as potential comparator. The study is intended to be conducted at up to 5 different centres in the United Kingdom to enrol up to 50 subjects. Subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Urinary Retention, Benign Prostatic Hyperplasia
Keywords
Benign prostatic hyperplasia, BPH, Urinary retention, prostate, hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UroLift System procedure
Arm Type
Experimental
Arm Description
All eligible,enroled subjects will undergo a UroLift procedure.
Arm Title
Retrospective Arm
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
UroLift System Procedure
Other Intervention Name(s)
Prostatic UroLift (PUL)
Intervention Description
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Primary Outcome Measure Information:
Title
Successful Trial Without Catheter Peri-procedurally
Description
Success is defined as a spontaneous voided volume of ≥100 mL associated with a post void residual volume by ultrasound <300 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation.
Time Frame
3 days (± 1 day) from index procedure
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
Description
Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device
Time Frame
Through 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
UroLift System Procedure Arm
Inclusion Criteria:
Male gender
Diagnosis of symptomatic BPH
Age ≥ 50 years
Prostate volume ≤ 100 cc per ultrasound (US)
Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
Exclusion Criteria:
An obstructive or protruding median lobe of the prostate
Previous BPH surgical procedure
Previous pelvic surgery
Urethral conditions that prevents insertion and delivery of device system into bladder
Retention volume of >1500 mL
Has not had prostate cancer excluded
History of prostate or bladder cancer
Biopsy of the prostate within the 6 weeks prior to Index Procedure
History of neurogenic or atonic bladder
Acute or chronic renal failure
Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
Known bladder stones within the prior 3 months or treatment within 12 months
Prostatitis requiring treatment (antibiotics) within the last year
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)
Life expectancy estimated to be less than 5 years
Desire to maintain fertility post procedure
Unable or unwilling to complete all required questionnaires and follow up assessments
Unable or unwilling to sign informed consent form
Currently enroled in any other clinical research trial that has not completed the primary endpoint
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Barber
Organizational Affiliation
Frimley Park Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Kayes
Organizational Affiliation
St James's University Hosptial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Rochester
Organizational Affiliation
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Toby Page
Organizational Affiliation
Freeman Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajesh Kavia
Organizational Affiliation
Central Middlesex Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikesh Thiruchelvam
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freeman Hospital
City
High Heaton
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
State/Province
Surrey
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
St. James's University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Central Middlesex Hospital
City
London
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prostatic Urethral Lift in Subject With Acute Urinary Retention
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