Prostatic Urethral Lift in Subject With Acute Urinary Retention

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prostatic Urethral Lift in Subject With Acute Urinary Retention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194737
• Other study ID #: CP00004
• Status: Completed
• Phase: N/A
• Start date: March 24, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: May 2021
• Source: NeoTract, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 3, 2020
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Urinary Retention
• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Retention

Intervention

Device:
• UroLift System Procedure
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Frimley Park Hospital	Frimley	Surrey
United Kingdom	Freeman Hospital	High Heaton	Newcastle Upon Tyne
United Kingdom	St. James's University Hospital	Leeds
United Kingdom	Central Middlesex Hospital	London
United Kingdom	Norfolk and Norwich University Hospital	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
NeoTract, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention	Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device	Through 3 months