Long term (5 year) results from the largest, prospective, randomized, controlled study of the minimally invasive prostatic urethral lift (PUL) (original) (raw)
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Journal of Endourology
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.
Prospective multi-center study elucidating patient experience after prostatic urethral lift
The Canadian journal of urology, 2014
The prostatic urethral Lift (PUL) procedure offers a novel treatment for men with lower urinary tract obstructive symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Most patients who seek LUTS/BPH treatment choose the intervention that offers the expectations of a significant improvement in quality of life and the least chance of short or long term morbidity. We report the results of a prospective, non-randomized study designed to further characterize the perioperative subject experience with the PUL procedure. The PUL procedure employs permanent implants to mechanically pull the prostatic lateral lobes apart. Subjects were ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥ 12, peak flow rate ≤ 12 mL, and prostate volume between 30 cc and 80 cc. Subject experience through 1 month was characterized by validated instruments designed to assess quality of recovery, work productivity, activity impairment, symptom response, quality of life, flow rate and sexua...
24-MONTH Durability After Crossover to the Prostatic Urethral Lift from Randomised, Blinded Sham
BJU International, 2016
To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. Patients and Methods In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift â system) into the prostatic lateral lobes. Patients were followed for 3 months after the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. Results At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P < 0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. Conclusions The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.
International Urology and Nephrology, 2020
Background Prostatic urethral lift (PUL), is a relatively new minimally invasive procedure for treatment of benign prostatic hyperplasia (BPH).This article is a systematic review and meta-analysis of all the articles published including follow-up of at least 24 months to analyze sustainability of results. Methods We performed a critical review in according to the preferred reporting items for systematic review and metaanalysis (PRISMA) guidelines. From a total 768 published articles that matched our search terms, 5 studies with minimum follow-up of 24 months were selected for comparison and data analyzed in terms of baseline characteristics, functional, and sexual health outcomes. Results Included in the analyses are five studies with a minimum follow-up of 24 months. A total of 386 patients underwent PUL and 322 patients (83.4%) are available for follow-up at 24 months. The randomized studies are grouped as group A and non-randomized studies as group B. At 24 months, the mean reduction in International Prostate Symptom Score (IPSS) from baseline was 9.1 in group A and 10.4 in group B. The mean improvement in peak flow rate (Q max) was 3.7 mL/s in group A and 3 mL/s in group B, and quality of life (QoL) improved by 2.2 in both groups. Conclusion PUL is a well-tolerated, minimally invasive therapy for BPH that provides favorable and durable symptomatic, sexual health, and functional outcomes up to 24 months. Longer follow-up and randomized studies comparing to current standards are required to further confirm the long-term sustainability of PUL.
The Canadian journal of urology, 2017
Benign prostatic hypertrophy (BPH) affects an estimated 60% of men over the age of 50 and 90% of men over the age of 80. The prostatic urethral lift (PUL) is a safe and effective office-based procedure that is used worldwide for the treatment of BPH in men who are dissatisfied with medications due to side effects or lack of efficacy or don't want to have a transurethral resection of the prostate due to the side effects and invasiveness of the procedure. In 2012 Barkin et al, published the standard technique for the delivery of the Urolift implant. The objective of this article is to describe the current state of the art advanced techniques for the delivery of the UroLift implant.
The Journal of Urology, 2013
Purpose: We report the first multicenter randomized blinded trial of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Materials and Methods: Men at least 50 years old with AUASI (American Urological Association Symptom Index) 13 or greater, a maximum flow rate 12 ml per second or less and a prostate 30 to 80 cc were randomized 2:1 between prostatic urethral lift and sham. In the prostatic urethral lift group small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking the prostatic urethral lift. The primary end point was comparison of AUASI reduction at 3 months. The prostatic urethral lift arm subjects were followed to 1 year and assessed for lower urinary tract symptoms, peak urinary flow rate, quality of life and sexual function. Results: A total of 206 men were randomized (prostatic urethral lift 140 vs sham 66). The prostatic urethral lift and sham AUASI was reduced by 11.1 AE 7.67 and 5.9 AE 7.66, respectively (p ¼ 0.003), thus meeting the primary end point. Prostatic urethral lift subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively, p <0.001. Peak urinary flow rate increased 4.4 ml per second at 3 months and was sustained at 4.0 ml per second at 12 months, p <0.001.