Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Freeman Hospital
High Heaton, Newcastle Upon Tyne, United Kingdom
Frimley Park Hospital
Frimley, Surrey, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
St. James's University Hospital
Leeds, United Kingdom
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.
Time frame: 3 days (± 1 day) from index procedure
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
Time frame: Through 3 months
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Central Middlesex Hospital
London, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom