No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Editorial Comment on "Efficacy and safety of prostatic urethral lift according to preoperative urinary retention and prostate volume: Japanese real-world multicenter data"
ResearchGate has not been able to resolve any citations for this publication.
A prostatic urethral lift (PUL) can be performed under local anesthesia in patients normally at high risk for general anesthesia due to multiple comorbidities. However, the clinical efficacy of PULs in patients with multiple comorbidities remains unknown. Therefore, in this this study, we aimed to evaluate the clinical efficacy of the PUL in patients with a high number of comorbidities by comparing its clinical efficacy in these patients with that in healthy individuals. We performed a retrospective observational cohort study, in which patients who underwent a PUL between December 2016 and January 2019 at a single tertiary care center were categorized into two groups: healthy individuals who wanted to preserve sexual function (Group 1) and patients with a high number of comorbidities who were at high risk for general anesthesia, based on an American Society of Anesthesiologists (ASA) score of ≥3 (Group 2). The International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), and post-void residual urine (PVR) were obtained preoperatively and compared throughout the 2-year follow-up. A total of 66 patients were enrolled, of whom 36 patients were included in Group 1 and 30 in Group 2. In Group 1, IPSS, IPSS quality of life (QoL), and Qmax significantly improved and were then maintained during follow-up, whereas, in Group 2, improvements in these parameters were not maintained during follow-up, except for IPSS QoL. Eleven patients (36%) in Group 2 required additional treatment for the recurrence of lower urinary tract symptoms. In conclusion, patients with a high number of comorbidities had a low therapeutic effect after PUL, suggesting a high rate of treatment failure. Therefore, comorbidity status should be considered when evaluating the potential benefits of the PUL procedure during preoperative counseling.
Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73–94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66–89%) reported being “much” or “very much better,” and 89% (CI 76–95%) would recommend the procedure. Compared to LL subjects, OML subjects’ symptoms improved at least as much at every time point (OML range 13.5–15.9, LL range 9.9–11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63–81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30–51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.
Objectives
Prostatic urethral lift (PUL) for benign prostatic hyperplasia has recently been initiated in Asia; therefore, few studies with real‐world data have been reported. This study evaluated the efficacy and safety of PUL using Japanese real‐world multicenter data.
Methods
Indications for PUL were based on relevant guidelines in Japan. The preoperative patient status, postoperative progress at 1 and 3 months, and perioperative complications were evaluated. Also, we compared preoperative urinary retention and nonurinary retention patients, and prostate volumes <30, 30 to <50, and ≥50 mL.
Results
A total of 160 patients were included in the study. The mean age was 75 years and the mean prostate volume was 44 mL. The International Prostate Symptom Score, quality of life score, maximum flow rate, and postvoid residual volume significantly improved 1 and 3 months postoperatively compared to preoperatively. The catheter‐free rates in the preoperative urinary retention group were 58.1%, 72.1%, 83.7%, and 88.4% on postoperative days 1, 7, 30, and 90, respectively. The catheter‐free rates in the nonurinary retention group were 94.9%, 98.3%, and 100% on postoperative days 1, 7, and 14, respectively. The group with a prostate volume ≥50 mL had a longer operation time and used significantly more implants; however, no difference was observed in the postoperative urinary status among the three groups.
Conclusions
PUL can be considered a safe and effective procedure for both preoperative urinary retention and nonurinary retention patients with prostate volumes <100 mL in older patients with comorbidities.
PURPOSE: We report the first multi-center randomized blinded trial of the Prostatic Urethral Lift (PUL) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Men of at least 50 years with American Urological Association Symptom Index (AUASI)ࣙ 13, a maximum flow rate (Qmax)≤ 12 ml/s, and a prostate 30-80 cc, were randomized 2:1 between PUL and sham. In PUL small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking PUL. The primary endpoint was comparison of AUASI reduction at 3 months. PUL arm subjects were followed to 1 year and assessed for LUTS, Qmax, quality of life (QOL), and sexual function. RESULTS AND CONCLUSIONS: 206 men were randomized (140 PUL:66 sham). PUL and sham AUASI were reduced by 11.1±7.67 and 5.9±7.66, respectively, (p=0.003) thus meeting the primary endpoint. PUL 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. Qmax increased 4.4 ml/s at 3 months and was sustained at 4.0 ml/s at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. The Prostatic Urethral Lift, reliably performed under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.