Prostatic Urethral Lift in Subject With Acute Urinary Retention

NeoTract

Status: Completed

Conditions: Acute Urinary Retention; Benign Prostatic Hyperplasia

Treatments: Device: UroLift System Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03194737

CP00004

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

UroLift System procedure

Experimental group

Description:

All eligible,enroled subjects will undergo a UroLift procedure.

Treatment:

Device: UroLift System Procedure

Retrospective Arm

No Intervention group

Description:

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