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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.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute Urinary Retention Benign Prostatic Hyperplasia Device: UroLift System Procedure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostatic Urethral Lift in Subject With Acute Urinary Retention
Actual Study Start Date : March 24, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: UroLift System procedure
All eligible,enroled subjects will undergo a UroLift procedure.
 Device: UroLift System Procedure
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Other Name: Prostatic UroLift (PUL)
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Assess catheter free rate at follow-up [ Time Frame: 3 days (± 1 day) from index procedure to 12 months ]
    Assess days free from catheter

  2. 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

  3. Need for further clean intermittent self-catheterisation (CISC) [ Time Frame: 3 days (± 1 day) from index procedure to 12 months ]
    CISC evaluation

  4. 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)

  5. 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

  6. 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

  7. 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

  8. Duration of pre-index procedure catheter [ Time Frame: Screening ]
    Summarise length of catherisation prior to index procedure (days)

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194737


Locations
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United Kingdom
Freeman Hospital
High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
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
Sponsors and Collaborators
NeoTract, Inc.
Investigators
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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
More Information
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Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT03194737     History of Changes
Other Study ID Numbers: CP00004
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by NeoTract, Inc.:
Benign prostatic hyperplasia
BPH
Urinary retention
prostate
hypertrophy
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Urinary Retention
Hyperplasia
Pathologic Processes
 Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases