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Prostatic Urethral Lift in Subject With Acute Urinary Retention

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ClinicalTrials.gov Identifier: NCT03194737
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE March 24, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
The primary clinical outcome measure will be successful trial without catheter [ Time Frame: 3 days (± 1 day) from index procedure ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
The primary clinical outcome measure will be successful trial without catheter [ Time Frame: 3 days (± 1 day) ]
Success is defined as a spontaneous voided volume of >100 mL associated with a post void residual volume by ultrasound <250 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation.
Change History Complete list of historical versions of study NCT03194737 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
Rate of serious adverse events (SAEs) related to BPH intervention [ Time Frame: Through 3 months ]
Adverse events will be coded using MedDRA and Common Terminology Criteria for Adverse Events (CTCAE) severity grades and will be presented by System Organ Class (SOC) and preferred term.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Secondary success will include subjects that fail the initial TWOC, but are able to void in subsequent TWOC. [ Time Frame: 6 weeks, 3, 6 and 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: January 3, 2019)
  • Assess catheter free rate at follow-up [ Time Frame: 3 days (± 1 day) from index procedure to 12 months ]
    Assess days free from catheter
  • Number of subjects who failed initial attempt but are able to void in subsequent TWOC [ Time Frame: 3 days (± 1 day) from index procedure to 12 months ]
    Failed initial TWOC
  • Need for further clean intermittent self-catheterisation (CISC) [ Time Frame: 3 days (± 1 day) from index procedure to 12 months ]
    CISC evaluation
  • Mean IPSS scores over follow-up [ Time Frame: 3 days (± 1 day) from index procedure, 6 weeks, 3, 6 and 12 months ]
    Calculate mean IPSS scores over follow-up (range score 0 to 35) Mild (symptom score less than of equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35)
  • Peak flow rate evaluation [ Time Frame: 3 days (± 1 day) from index procedure, 6 weeks, 3, 6 and 12 months ]
    Calculate peak flow rate (mL/sec) over follow-up
  • Post void residual (PVR) (mL) volume [ Time Frame: 3 days (± 1 day) from index procedure, 6 weeks, 3, 6 and 12 months ]
    PVR volume over follow-up
  • Subjects free from alternative surgical procedure for BPH [ Time Frame: 3 days (± 1 day) from index procedure to 12 months ]
    Evaluate number of non-UroLift interventions during follow-up
  • Duration of pre-index procedure catheter [ Time Frame: Screening ]
    Summarise length of catherisation prior to index procedure (days)
  • Rate of adverse events [ Time Frame: Procedure to 12 months ]
    Adverse events will be summarised by overall adverse events (AEs), severe AEs (grade 3 or higher on CTCAE scale, AEs related to device and/or procedure, serious adverse events (SAEs) and SAEs related to device and/or procedure. Adverse events will be coded using MedDRA and Common Terminology Criteria for Adverse Events (CTCAE) severity grades and will be presented by System Organ Class (SOC) and preferred term.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostatic Urethral Lift in Subject With Acute Urinary Retention
Official Title  ICMJE Prostatic Urethral Lift in Subject With Acute Urinary Retention
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Urinary Retention
  • Benign Prostatic Hyperplasia
Intervention  ICMJE Device: UroLift System Procedure
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Other Name: Prostatic UroLift (PUL)
Study Arms  ICMJE
  • Experimental: UroLift System procedure
    All eligible,enroled subjects will undergo a UroLift procedure.
    Intervention: Device: UroLift System Procedure
  • No Intervention: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

UroLift System Procedure Arm

Inclusion Criteria:

  1. Male gender
  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:

  1. An obstructive or protruding median lobe of the prostate
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03194737
Other Study ID Numbers  ICMJE CP00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NeoTract, Inc.
Study Sponsor  ICMJE NeoTract, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neil Barber Frimley Park Hospital
Principal Investigator: Oliver Kayes St James's University Hosptial
Principal Investigator: Mark Rochester Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Principal Investigator: Toby Page Freeman Health System
Principal Investigator: Rajesh Kavia Central Middlesex Hospital
Principal Investigator: Nikesh Thiruchelvam Cambridge University Hospitals NHS Foundation Trust
PRS Account NeoTract, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP