Prostatic Urethral Lift in Subject With Acute Urinary Retention

NCT03194737 | Completed Results FDA Device

• 1 other identifier: CP00004
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 6

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).

Conditions

Acute Urinary Retention; Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia; BPH; Urinary retention; prostate; hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention

  Through 3 months

Study Arms (2)

UroLift System procedure

EXPERIMENTAL

All eligible,enroled subjects will undergo a UroLift procedure.

Device: UroLift System Procedure

Retrospective Arm

NO INTERVENTION

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

Interventions

UroLift System Procedure DEVICE

Minimally invasive procedure in patients with acute urinary retention secondary to BPH.

Also known as: Prostatic UroLift (PUL)

UroLift System procedure

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoTract, Inc.: lead

Study Sites (6)

Freeman Hospital

High Heaton, Newcastle Upon Tyne, NE7 7DN, United Kingdom

Location

Frimley Park Hospital

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

St. James's University Hospital

Leeds, United Kingdom

Location

Central Middlesex Hospital

London, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention; Hypertrophy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Data Retrospectively collected from the invasive Benign prostatic hyperplasia (BPH) surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) was not directly comparable to the prospective UroLIFT system outcomes because of inherent standard of care differences between interventions, standard of care at sites and recording in medical records

Results Point of Contact

• Title: Emily Friedland, Director, Global Clinical Operations
• Organization: Teleflex/NeoTract

emily.friedland@teleflex.com

925.387.6014

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: March 24, 2018
• Primary Completion: January 21, 2019
• Study Completion: March 3, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)