Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study

Gregg Eure, Steven Gange, Peter Walter, Ansar Khan, Charles Chabert, Thomas Mueller, Paul Cozzi, Manish Patel, Sheldon Freedman, Peter Chin, Steven Ochs, Andrew Hirsh, Michael Trotter, Douglas Grier, Gregg Eure, Steven Gange, Peter Walter, Ansar Khan, Charles Chabert, Thomas Mueller, Paul Cozzi, Manish Patel, Sheldon Freedman, Peter Chin, Steven Ochs, Andrew Hirsh, Michael Trotter, Douglas Grier

Abstract

Introduction: This study expands results from recent prostatic urethral lift (PUL) clinical trials by examining outcomes within a large unconstrained multicenter data set. Methods: Retrospective chart review and analysis of 1413 consecutive patients who received PUL in North America and Australia was performed. International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax) were evaluated at 1, 3, 6, 12, and 24 months post-procedure for all nonurinary retention subjects (Group A) and retention subjects (Group B). Within Group A outcomes were further analyzed using paired t-tests and 95% mean confidence intervals under the following parameters: IPSS baseline ≥13, age, prostate size, site of service, prostate cancer treatment, and diabetic status. Adverse events, surgical interventions, and catheterization rates were summarized in detail. Results: Compared with the randomized controlled prosatic urethral lift (L.I.F.T.) study, subjects in this retrospective study were older and less symptomatic. After PUL, mean IPSS for Group A improved significantly from baseline by at least 8.1 points throughout follow-up. No significant differences were observed between Group A and B follow-up symptom scores. Within Group A, subjects with an IPSS baseline ≥13 behaved similarly to L.I.F.T. subjects. Age, prostate volume, site of service, prior cancer treatment, and diabetic status did not significantly affect PUL outcomes. When completed in a clinic office, PUL resulted in less side effects and catheter placement compared to other sites of service. Previous prostate cancer treatment did not elevate adverse events of high concern such as incontinence and infection. Conclusion: PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.

Keywords: BPH; LUTS; PUL; benign prostatic hyperplasia; lower urinary tract symptoms; prostatic urethral lift; real world; retrospective study.

Conflict of interest statement

G.E., P.C., S.G., D.G., A.H., T.M., and P.W. are NeoTract/Teleflex, Inc., consultants.

Figures

FIG. 1.
FIG. 1.
PUL procedure depicting implant delivery sequence and the result effect on a prostate obstructed by BPH. The implant is delivered into the encroaching lateral lobes of a prostate (A) by introducing the device under cystoscopic guidance (B), compressing the lobe with the delivery device, deploying a needle through the prostatic lobe and capsule (C), retracting the needle, tightening tension on the monofilament connector, and securing implant with a urethral end-piece (D). Additional implants are delivered as required (E) to maintain an expanded urethral lumen (F). BPH, benign prostatic hyperplasia; PUL = prostatic urethral lift. (Images copyrighted and printed with permission by NeoTract, Inc.)
FIG. 2.
FIG. 2.
IPSS response to PUL in RWR subjects compared with pivotal clinical study (L.I.F.T.) subjects. IPSS = International Prostate Symptom Score; RWR = real-world retrospective.
FIG. 3.
FIG. 3.
Prostate volume distribution within the RWR total study population.
FIG. 4.
FIG. 4.
IPSS improvement in RWR subjects with prostate volumes less than or greater than or equal to 30 cc.
FIG. 5.
FIG. 5.
IPSS improvement for RWR prostate cancer therapy subjects in response to PUL.

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