Prostatic Urethral Lift in Subject With Acute Urinary Retention

Not Applicable

Completed

• Conditions: Acute Urinary Retention; Benign Prostatic Hyperplasia
• Interventions: Device: UroLift System Procedure

• Registration Number: NCT03194737
• Lead Sponsor: NeoTract, Inc.

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.

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Study Start: 2018-03-24
• Primary Completion: 2019-01-21
• Study Completion: 2020-03-03
• Status Verified: 2021-05
• Results First Submitted: 2021-05-06
• Results First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Results First Posted: 2021-07-16
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UroLift System procedure	UroLift System Procedure	All eligible,enroled subjects will undergo a UroLift procedure.

Primary Outcome Measures

Name	Time	Method
Successful Trial Without Catheter Peri-procedurally	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 Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention	Through 3 months	Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device

Trial Locations

Locations (6)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Central Middlesex Hospital; 🇬🇧 London, United Kingdom

St. James's University Hospital; 🇬🇧 Leeds, United Kingdom

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

Freeman Hospital; 🇬🇧 High Heaton, Newcastle Upon Tyne, United Kingdom

Frimley Park Hospital; 🇬🇧 Frimley, Surrey, United Kingdom