Prostatic Urethral Lift in Subject With Acute Urinary Retention

Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Acute Urinary Retention
• Intervention / Treatment: Device: UroLift System Procedure

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: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom
    • Addenbrooke's Hospital
  • Leeds, United Kingdom
    • St. James's University Hospital
  • London, United Kingdom
    • Central Middlesex Hospital
  • Norwich, United Kingdom
    • Norfolk and Norwich University Hospital
  • Newcastle Upon Tyne
    • High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Freeman Hospital
  • Surrey
    • Frimley, Surrey, United Kingdom, GU16 7UJ
      • Frimley Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days (± 1 day) from index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through 3 months

Collaborators and Investigators

• Sponsor: NeoTract, Inc.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2018
• Primary Completion (Actual): January 21, 2019
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Urinary retention; prostate; BPH; Benign prostatic hyperplasia; hypertrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Prostatic Diseases; Urination Disorders; Prostatic Hyperplasia; Hyperplasia; Urinary Retention
• Other Study ID Numbers: CP00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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