CP00004 PULSAR Study
Research type
Research Study
Full title
Prostatic Urethral Lift in Subjects with Acute Urinary Retention Study (PULSAR Study)
IRAS ID
228068
Contact name
Oliver Kayes
Contact email
Sponsor organisation
Teleflex
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 16 days
Research summary
The study is a multi-center, consecutive, prospective feasibility study of the UroLift® System in acute urinary retention (AR) patients. A retrospective dataset of similar patients that underwent an invasive procedure to treat AR will be analysed against UroLift data. A maximum of 50 subjects undergoing UroLift will be enrolled across three study centres in Great Britain, with each site contributing at least 10 subjects. This feasibility study is the first to assess patients undergoing Prostatic UroLift (PUL) with AR and will determine if a larger, quantitative study should be conducted and its optimal methodology. By evaluating results pertaining to study design, endpoint, conduct of trial, site performance, subject compliance, and inclusion criteria specifically, a robust safety and effectiveness study can follow. Clinical improvements will be assessed post-procedure, at 6 weeks, and at months 3, 6, and 12 post-index procedure.
The UroLift System is manufactured by NeoTract, Inc. and consists of a delivery system and a UroLift Implant comprised of a nitinol Capsular Tab (CT) that rests on the outer capsule of the prostate and a stainless steel Urethral End-Piece (UE) that rests on the urethral wall. The CT and UE are connected by a length of Polyethylene Terephthalate (PET) monofilament suture. During the Prostatic Urethral Lift procedure, customised transprostatic implants are placed to hold open the obstructing prostatic lobes and expand the urethral lumen. The UroLift System is inserted transurethrally through a rigid sheath under cystoscopic visualisation. When the targeted area of the encroaching lateral prostatic lobe is located, the lobe is displaced by applying an outward pressure away from the urethra such that the obstructive lobe is compressed and the prostatic fossa enlarged. By applying this force, the effect of lifting the lobe can be tested before delivering an implant. A 19 gauge needle is then deployed from the tip of the delivery device extending from the intraluminal urethral wall through the prostatic capsular surface. The CT is then delivered through the hollow bore of the needle. As the needle is retracted, the CT engages the capsular prostatic surface and settles into a stable position, tension is applied, and the UE is secured onto the monofilament apposed to the urethral wall. Because the fibromuscular capsule is less compliant than the peri-urethral tissue, the CT holds firmly in place while the UE holds the lobe in its displaced position thus expanding the urethral lumen.
REC name
Wales REC 6
REC reference
17/WA/0242
Date of REC Opinion
31 Jul 2017
REC opinion
Further Information Favourable Opinion