Clinical trial NCT03194737: Prostatic Urethral Lift in Subject With Acute Urinary Retention
Official title: Prostatic Urethral Lift in Subject With Acute Urinary Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Urinary Retention
Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
BPH
Urinary retention
prostate
hypertrophy
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 101
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Successful Trial Without Catheter Peri-procedurally
timeFrame: 3 days (± 1 day) from index procedure
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
timeFrame: Through 3 months
Other outcomes:
Locations:
city: High Heaton
country: United Kingdom
facility: Freeman Hospital
state: Newcastle Upon Tyne
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Surrey
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
city: London
country: United Kingdom
facility: Central Middlesex Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
Study officials:
affiliation: Frimley Park Hospital
name: Neil Barber
role: PRINCIPAL_INVESTIGATOR
affiliation: St James's University Hosptial
name: Oliver Kayes
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Mark Rochester
role: PRINCIPAL_INVESTIGATOR
affiliation: Freeman Health System
name: Toby Page
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Middlesex Hospital
name: Rajesh Kavia
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Nikesh Thiruchelvam
role: PRINCIPAL_INVESTIGATOR
References: