Prostatic urethral lift for subjects in urinary retention (PULSAR): 12‐Month results of a prospective controlled trial compared with real‐world outcomes

Abstract Objective To examine the safety and efficacy of prostatic urethral lift (PUL) in acute urinary retention (AUR) patients within a controlled (PULSAR) and real‐world setting (Real‐World Retrospective study). Materials and methods PULSAR was a 12‐month prospective study of PUL in AUR patients (n = 51) performed at six centres in the United Kingdom; enrolled BPH patients aged ≥50 years, with prostate volume of ≤100 cc. AUR was defined as being catheter dependent with at least one prior failed trial without catheter (TWOC) while on an alpha‐blocker. RWR consisted of 3226 consecutive PUL patients across 22 international sites treated between July 2017 and March 2020; 469 of whom were in urinary retention (RWRr), that is, catheter‐dependent at the time of their procedure. Symptom response, uroflow and catheter independence rates were compared between PULSAR and RWRr subjects. A logistical regression model was constructed to evaluate patient baseline and dynamic factors predicting success after the procedure. Results Seventy‐three percent of PULSAR subjects were catheter independent and free from surgical reintervention at 12 months post‐PUL. Success was associated with higher voiding efficiency during the perioperative period. Slightly higher catheter‐independent rates (80%) were seen in RWRr patients; variables that influenced success included age <70 years, lower baseline prostate‐specific antigen (PSA), lower baseline post‐void residual (PVR) and shorter pre‐procedural catheter duration. Logistic regression of the combined PULSAR and RWRr retention groups revealed that procedural age <70 years and higher bladder voiding efficiency (BVE) were associated with success. Conclusions Lower baseline PSA and PVR, younger age and shorter pre‐procedure catheter durations drove successful outcomes in AUR patients undergoing PUL. Post‐PUL voiding efficiencies may help ascertain long‐term response to treatment

Prostatic urethral lift for subjects in urinary retention (PULSAR): 12‐Month results of a prospective controlled trial compared with real‐world outcomes

Funder: NeoTract, Inc./TeleflexAbstractObjectiveTo examine the safety and efficacy of prostatic urethral lift (PUL) in acute urinary retention (AUR) patients within a controlled (PULSAR) and real‐world setting (Real‐World Retrospective study).Materials and methodsPULSAR was a 12‐month prospective study of PUL in AUR patients (n = 51) performed at six centres in the United Kingdom; enrolled BPH patients aged ≥50 years, with prostate volume of ≤100 cc. AUR was defined as being catheter dependent with at least one prior failed trial without catheter (TWOC) while on an alpha‐blocker. RWR consisted of 3226 consecutive PUL patients across 22 international sites treated between July 2017 and March 2020; 469 of whom were in urinary retention (RWRr), that is, catheter‐dependent at the time of their procedure. Symptom response, uroflow and catheter independence rates were compared between PULSAR and RWRr subjects. A logistical regression model was constructed to evaluate patient baseline and dynamic factors predicting success after the procedure.ResultsSeventy‐three percent of PULSAR subjects were catheter independent and free from surgical reintervention at 12 months post‐PUL. Success was associated with higher voiding efficiency during the perioperative period. Slightly higher catheter‐independent rates (80%) were seen in RWRr patients; variables that influenced success included age &lt;70 years, lower baseline prostate‐specific antigen (PSA), lower baseline post‐void residual (PVR) and shorter pre‐procedural catheter duration. Logistic regression of the combined PULSAR and RWRr retention groups revealed that procedural age &lt;70 years and higher bladder voiding efficiency (BVE) were associated with success.ConclusionsLower baseline PSA and PVR, younger age and shorter pre‐procedure catheter durations drove successful outcomes in AUR patients undergoing PUL. Post‐PUL voiding efficiencies may help ascertain long‐term response to treatment.</jats:sec

Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results

OBJECTIVE To report 12-month safety and effectiveness outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume prostates. METHODS One hundred and one men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent a robotic-assisted Aquablation procedure in a prospective multicenter international clinical trial. Functional and safety outcomes were assessed at 12 months postoperatively. RESULTS Mean prostate volume was 107 cc (range 80-150). Mean operative time was 37 minutes and mean Aquablation resection time was 8 minutes. The average length of hospital stay following the procedure was 1.6 days. Mean International Prostate Symptom Score improved from 23.2 at baseline to 6.2 at 12 months (P 100 at baseline). Antegrade ejaculation was maintained in 81% of sexually active men. No patient underwent a repeat procedure for BPH symptoms. There was a 2% de novo incontinence rate at 12 months, and 10 patients did require a transfusion postoperatively while 5 required take back fulgurations. At 12 months, prostate-specific antigen reduced from 7.1 ± 5.9 ng/mL at baseline to 4.4 ± 4.3 ng/mL. CONCLUSION The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80-150 cc) after 1 year of follow-up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands

Aquablation therapy in large prostates (80-150 cc) for lower urinary tract symptoms due to benign prostatic hyperplasia: WATER II 3-year trial results.

OBJECTIVE: The objective of this study is to determine if Aquablation therapy can maintain its effectiveness in treating men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with large-volume (80-150 cc) prostates at 3 years. SUBJECTS AND METHODS: One hundred one men with moderate-to-severe BPH symptoms and prostate volumes between 80 and 150 cc were enrolled in a prospective, nonrandomized, multicenter, international clinical trial in late 2017. Baseline, procedural, and follow-up parameters were recorded at baseline and scheduled postoperative visits. IPSS, Qmax, and treatment failure are reported at 3 years. RESULTS: The mean prostate volume was 107 cc (range 80-150). Mean IPSS improved from 23.2 at baseline to 6.5 at 3 years (16.3-point improvement, p &lt; 0.0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 3 years (improvement of 3.4 points, p &lt; 0.0001). Maximum urinary flow increased from 8.7 to 18.5 cc/s. At 3 year follow-up, 6% of treated patients needed BPH medication and an additional 3% required surgical retreatment for LUTS. CONCLUSIONS: Three-year follow-up demonstrates a sustained symptom reduction response along with low irreversible complications to Aquablation in men with LUTS due to BPH and prostates of 80-150 cc. Current treatment options available for men with prostates of this size have similar efficacy outcomes but are burdened with high rates of irreversible complications. There are now numerous clinical studies with Aquablation used in various prostates sizes, and it should be offered as an option to men with LUTS due to BPH