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Completed

NCT Number: NCT03194737

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).

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Key information

Conditions

Acute Urinary Retention Benign Prostatic Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypertrophy Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Freeman Hospital, High Heaton, Newcastle Upon Tyne, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UroLift System Procedure

Device

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

Other names: Prostatic UroLift (PUL)

Primary outcomes

  1. Successful Trial Without Catheter Peri-procedurally

    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 outcomes

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

    Time frame: Through 3 months

    Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device

Sponsors and collaborators

Lead sponsor

NeoTract, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 21, 2017
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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