Efficacy and safety of prostatic urethral lift according to preoperative urinary retention and prostate volume: A Japanese real‐world multicenter data
Benign prostatic hyperplasia (BPH) is a common disease in older men that affects the quality of life (QOL). , BPH is associated with a variety of etiologies. BPH leads to lower urinary tract symptoms (LUTS), urinary retention, and bladder function deterioration. Moderate to severe LUTS was more common in older men and associated with a decreased quality of health and increased incapacity for activities of daily living. , The increase in hospitalizations for adverse events of BPH indicates that the severe adverse events of BPH persist despite the widespread use of medications to treat BPH. Various surgical treatments have been employed for BPH in older men. Prostatic urethral lift (PUL) is a minimally invasive surgical treatment, which is less invasive than conventional prostate surgery. , , To date, PUL procedure using the UroLift ® System is one of the most widely employed surgeries for BPH. PUL uses a transprostatic implant to relieve the symptoms of urinary outflow obstruction without incision, heating, or excision of tissue using an energy source; PUL can be used to treat a varying prostate enlargement sizes and anatomical structures up to 100 mL. BPH surgery in patients with preoperative urinary retention has a lower postoperative catheter‐free rate than that in patients without preoperative urinary retention. , Catheter‐free factors associated with PUL in patients with preoperative urinary retention include age <70 years, baseline prostate‐specific antigen (PSA), low postvoid residual volume (PVR) at baseline, and short catheter placement duration. PUL has been employed as a minimally invasive surgical treatment for BPH since April 2022 in Japan. However, few studies have reported on the PUL outcomes in Japan and Asia in general. , According to the proper use guideline of the Japanese Urological Association, PUL in Japan is indicated in patients considered high risk, namely, older patients or those with comorbidities. This is a notable point of this study. Therefore, this study evaluated the efficacy and safety of PUL using real‐world multicenter data. Moreover, we compared the postoperative urinary conditions between preoperative urinary retention patients and nonurinary retention patients, and prostate volumes <30, 30–50, and ≥50 mL.   Study design This multicenter retrospective study investigated the treatment of patients with BPH who underwent PUL using the UroLift ® 2 system (Teleflex Medical Japan, Tokyo, Japan) from May 2022 to February 2024 at Yotsuya Medical Cube (Tokyo, Japan), Tsurugi Hospital (Ishikawa, Japan), Iwate Prefectural Iwai Hospital (Iwate, Japan), and Chiba Prefectural Sawara Hospital (Chiba, Japan). The Ethics Committee approved this study protocol (No: YCR24001). The indications were based on the proper use guidelines by the Japanese Urological Association for PUL. In Japan, PUL is indicated for high‐risk patients owing to older age or comorbidities. Patients with prostate volumes of ≥100 mL were considered ineligible for PUL. The inclusion criteria were prostate volume <100 mL and no metal allergies. The primary endpoint was the perioperative safety and efficacy of the PUL. The secondary endpoint was the urinary status postoperatively at 1 and 3 months compared to the preoperative urinary status. Patients were consecutively enrolled from the first case at the four facilities to reduce selection bias. Patient backgrounds, perioperative outcomes, and outcomes up to 3 months postoperatively were examined. Subgroup analysis was performed in preoperative urinary retention and nonurinary retention patients. In particular, the catheter‐free rate, time required to relieve urinary retention, and transient urinary retention rates were compared. In addition, a subgroup analysis was performed based on the prostate volume. The Japanese Urological Association guidelines set cut‐off values of 30 and 50 mL for determining the severity of BPH. The prostate volume was divided into three groups (<30, 30 to <50, and ≥50 mL), and their preoperative status, perioperative results, and postoperative course were compared. Equipment Each PUL surgery was performed using the UroLift ® 2 system. The PUL surgical technique followed previously reported methods (Figure ). Multiple implants were used to ensure the opening of the anterior urethra. The patient was placed in a high lithotomy position under general, lumbar, or local anesthesia. Local anesthesia was administered according to the L.I.F.T. study, diazepam was administered orally for 30 min before injecting 2% lidocaine into the bladder via a catheter, and cold 2% lidocaine gel was injected into the urethra. Parameters Preoperative patient data were obtained for the following variables: age, body mass index (BMI), prostate volume (mL), PSA level (ng/mL), International Prostate Symptom Score (IPSS), QOL score, Overactive Bladder Symptom Score (OABSS), International Index of Erectile Function (IIEF‐5), maximum flow rate (Qmax) (mL/s), and PVR. We evaluated bladder voiding efficiency (BVE) to assess the urinary efficiency. BVE is calculated as urine volume/urine volume plus residual urine volume. We estimated the preoperative prostate volume using ultrasonography and evaluated the total operative time (min), number of implants, and postoperative conditions, such as changes in the perioperative hemoglobin (Hb) (g/dL) and C‐reactive protein (mg/dL) levels, as well as postoperative fever. Transient urinary retention was defined as the need for a catheter for urinary drainage for at least 24 h after PUL. We defined urinary retention as a complaint of inability to empty the bladder completely, requiring a urinary catheter or clean intermittent catheterization. We defined postoperative fever as a significant increase in the body temperature of ≥38.0°C and assessed the urinary conditions preoperatively and 1 and 3 months postoperatively. Complications were evaluated using a modified Clavien–Dindo grading system. Statistical analysis Patient characteristics are expressed as each continuous variable's mean and standard deviation. Statistical analyses were performed using JMP software, version 9.0 (SAS Institute Inc., Cary, NC, USA). Statistical analyses were conducted using the Mann–Whitney U test and Wilcoxon signed‐rank test for two‐group comparisons and the Kruskal–Wallis test followed by the Steel–Dwass test for multigroup comparisons. Intergroup differences in categorical variables were assessed using Fisher's exact or chi‐squared tests. A paired t ‐test and Wilcoxon signed‐rank test were used for comparing the variables. p < 0.05 indicated statistically significant results.   This multicenter retrospective study investigated the treatment of patients with BPH who underwent PUL using the UroLift ® 2 system (Teleflex Medical Japan, Tokyo, Japan) from May 2022 to February 2024 at Yotsuya Medical Cube (Tokyo, Japan), Tsurugi Hospital (Ishikawa, Japan), Iwate Prefectural Iwai Hospital (Iwate, Japan), and Chiba Prefectural Sawara Hospital (Chiba, Japan). The Ethics Committee approved this study protocol (No: YCR24001). The indications were based on the proper use guidelines by the Japanese Urological Association for PUL. In Japan, PUL is indicated for high‐risk patients owing to older age or comorbidities. Patients with prostate volumes of ≥100 mL were considered ineligible for PUL. The inclusion criteria were prostate volume <100 mL and no metal allergies. The primary endpoint was the perioperative safety and efficacy of the PUL. The secondary endpoint was the urinary status postoperatively at 1 and 3 months compared to the preoperative urinary status. Patients were consecutively enrolled from the first case at the four facilities to reduce selection bias. Patient backgrounds, perioperative outcomes, and outcomes up to 3 months postoperatively were examined. Subgroup analysis was performed in preoperative urinary retention and nonurinary retention patients. In particular, the catheter‐free rate, time required to relieve urinary retention, and transient urinary retention rates were compared. In addition, a subgroup analysis was performed based on the prostate volume. The Japanese Urological Association guidelines set cut‐off values of 30 and 50 mL for determining the severity of BPH. The prostate volume was divided into three groups (<30, 30 to <50, and ≥50 mL), and their preoperative status, perioperative results, and postoperative course were compared.   Each PUL surgery was performed using the UroLift ® 2 system. The PUL surgical technique followed previously reported methods (Figure ). Multiple implants were used to ensure the opening of the anterior urethra. The patient was placed in a high lithotomy position under general, lumbar, or local anesthesia. Local anesthesia was administered according to the L.I.F.T. study, diazepam was administered orally for 30 min before injecting 2% lidocaine into the bladder via a catheter, and cold 2% lidocaine gel was injected into the urethra.   Preoperative patient data were obtained for the following variables: age, body mass index (BMI), prostate volume (mL), PSA level (ng/mL), International Prostate Symptom Score (IPSS), QOL score, Overactive Bladder Symptom Score (OABSS), International Index of Erectile Function (IIEF‐5), maximum flow rate (Qmax) (mL/s), and PVR. We evaluated bladder voiding efficiency (BVE) to assess the urinary efficiency. BVE is calculated as urine volume/urine volume plus residual urine volume. We estimated the preoperative prostate volume using ultrasonography and evaluated the total operative time (min), number of implants, and postoperative conditions, such as changes in the perioperative hemoglobin (Hb) (g/dL) and C‐reactive protein (mg/dL) levels, as well as postoperative fever. Transient urinary retention was defined as the need for a catheter for urinary drainage for at least 24 h after PUL. We defined urinary retention as a complaint of inability to empty the bladder completely, requiring a urinary catheter or clean intermittent catheterization. We defined postoperative fever as a significant increase in the body temperature of ≥38.0°C and assessed the urinary conditions preoperatively and 1 and 3 months postoperatively. Complications were evaluated using a modified Clavien–Dindo grading system.   Patient characteristics are expressed as each continuous variable's mean and standard deviation. Statistical analyses were performed using JMP software, version 9.0 (SAS Institute Inc., Cary, NC, USA). Statistical analyses were conducted using the Mann–Whitney U test and Wilcoxon signed‐rank test for two‐group comparisons and the Kruskal–Wallis test followed by the Steel–Dwass test for multigroup comparisons. Intergroup differences in categorical variables were assessed using Fisher's exact or chi‐squared tests. A paired t ‐test and Wilcoxon signed‐rank test were used for comparing the variables. p < 0.05 indicated statistically significant results.   The mean age and prostate volume were 74.8 years and 43.8 mL, respectively. The median BMI, PSA, IPSS, QOL score, Qmax, and PVR were 23.7 kg/m 2 , 3.6 ng/mL, 21.5 points, 5.1 points, 9.1 mL/s, and 121 mL, respectively (Table ). Furthermore, the number of patients with preoperative urinary retentions was 43 (26.9%). The number of patients who received antiplatelet or anticoagulant therapies was 49 (30.6%). The mean operative time was 19.2 min (Table ). The number of patients who underwent surgery under general, lumbar, and local anesthesia was 125 (78.1%), 15 (9.4%), and 20 (12.5%), respectively; the mean number of implants inserted was 5.1. The mean Hb level decrease and C‐reactive protein level increase were 0.7 g/dL and 0.2 mg/dL, respectively. The number of patients with transient postoperative urinary retention was 24 (15.0%), whereas the catheter‐free rates at 1 day, 1 week, 1 month, and 3 months were 136 (85.0%), 146 (91.3%), 153 (95.6%), and 155 (96.9%), respectively (Table ). Only one patient reported a pelvic hematoma resulting in adverse events requiring prolonged hospital stay and complications above Clavien–Dindo grade 2. Urinary retention could not be relieved within 3 months postoperatively in 5 (5/43, 11.6%) preoperative urinary retention cases. The majority of patients (151/160, 94.4%) remained medication‐free at the end of the study, with only nine patients, including five patients with postoperative urinary retention, who resumed drug therapy during follow‐up. The postoperative mean IPSS scores at 1 and 3 months were 11.5 and 11.0 points, respectively, which were significantly lower than the preoperative scores (Figure ). Additionally, the QOL scores at 1 and 3 months postoperatively were 2.4 and 2.1 points, respectively, which were significantly lower than those measured preoperatively. The postoperative Qmax at 1 and 3 months were 11.9 and 12.9 mL/s, which were significantly higher than the preoperative values. Moreover, the postoperative PVRs at 1 and 3 months were 47.9 and 40.1 mL, respectively, which were significantly lower than the preoperative PVRs. At 3 months postoperatively, 94.4% of the patients were able to discontinue preoperative BPH medications. The number of preoperative urinary retention patients (Group A) and nonurinary retention patients (Group B) was 43 (26.9%) and 117 (73.1%), respectively (Table ). Regarding baseline patient characteristics, PSA level, IPSS, and QOL scores were significantly higher in Group A than in Group B. The catheter‐free rates in Group A were 58.1% and 72.1% on postoperative days 1 and 7, respectively, and 83.7% and 88.4% at 1 and 3 months, respectively. The catheter‐free rates in Group B were 94.9% and 98.3% on postoperative days 1 and 7, respectively, and 100% and 100% at 1 and 3 months, respectively. In 41 (25.6%) patients, the urinary catheter was not placed immediately after PUL, whereas it was placed in 119 (74.4%) patients. Transient urinary retention occurred in 6 (14.6%) and 21 (17.6%) cases among 41 and 119 cases with and without a postoperative urinary catheter, respectively. The number of patients with prostate volumes <30, 30 to <50, and ≥50 mL were 33 (20.6%), 78 (48.8%), and 49 (30.6%), respectively (Table ). Preoperative urinary retention was higher in patients with a prostate volume ≥50 mL. Regarding baseline patient characteristics, PSA was significantly higher in the group with a larger prostate volume. The operative time was significantly longer and the number of implants was significantly higher in the group with larger prostate volumes. The incidences of transient postoperative urinary retention were 9.1%, 12.8%, and 26.5% in the groups with prostate volumes <30, 30 to <50, and ≥50 mL, respectively. The IPSS, QOL score, and Qmax at 1 and 3 months postoperatively were not significantly different among the three groups. The PVR and BVE at 1 month postoperatively were not significantly different among the three groups; however, the PVR and the BVE at 3 months postoperatively of the group with a prostate volume ≥50 mL were significantly higher and lower, respectively, than those of the other groups. The OABSS was significantly lower at 1 (4.7 ± 3.0 points) and 3 months (4.3 ± 2.9 points) postoperatively compared to the preoperative OABSS (6.2 ± 3.4 points). Improvements in the daytime and nighttime urinary frequency scores were particularly significant. No significant change was observed in the IIEF‐5 at 1 (16.7 ± 6.0 points) and 3 months (16.1 ± 5.0 points) postoperatively compared to the preoperative IIEF‐5 (16.4 ± 4.5 points). These results were based on 33 patients who had preoperative sexual function and could be evaluated with IIEF‐5 continuously for up to 3 months postoperatively. In this study, 49 patients (30.6%) were taking antiplatelet or anticoagulant medications preoperatively. Perioperative antiplatelet and anticoagulant medications were discontinued for a short period in 33 eligible patients, and PUL was performed in 16 patients who continued to use antiplatelet or anticoagulant medications. No significant difference was observed in the perioperative Hb change between the 16 patients who continued antiplatelet or anticoagulant medications in the perioperative period and the other 144 patients (0.64 and 0.72 g/dL, respectively).   This study revealed that the IPSS, QOL score, Qmax, and PVR significantly improved 1 and 3 months postoperatively compared to the preoperative values. In this study, similar to previous reports, PUL provided rapid symptomatic relief to patients, with improvements in the IPSS, QOL scores, and PVR of 40%–50% at 1 month postoperatively compared to the preoperative values. , , In this study, the overall catheter‐free rates were 85.0% and 91.3% on postoperative days 1 and 7, respectively, and 95.6% and 96.9% at 1 and 3 months postoperatively, respectively. The mean age of the present study participants was 75 years, which is higher than the mean ages of those in the L.I.F.T. (67 years) and real‐world evidence studies (70 years). , Moreover, this study comprised older patients with comorbidities, such as hypertension, diabetes, cardiovascular disease, brain disease, and respiratory disease, which are indicators for proper use of PUL in Japan (Table ). This study is notable for the presence of elderly patients with many comorbidities, according to the specific PUL indications in Japan. The initial PUL outcomes revealed PUL to be safe and effective in older patients with comorbidities. Transient postoperative urinary retention is a common early complication of PUL. In the preoperative nonurinary retention patients, the catheter‐free rates were 55%–80%, 90%, and 94% on postoperative days 1, 2, and 5, respectively, and 98% at 1 month postoperatively. , , , In contrast, in patients with preoperative urinary retention, the catheter‐free rates were 56% and 69% on postoperative days 3 and 5, respectively, and 71%–83% at 1 month postoperatively. , Notably, the results of this study are comparable to those of previous studies. , The rate of postoperative catheter‐free status in preoperative urinary retention patients was reported as 73%–80% at 12 months for PUL, which is comparable to the 12 months postoperative catheter‐free rates reported for transurethral resection of the prostate and photoselective vaporization of the prostate (79.1% and 88.0%, respectively). , The decision to use a urinary catheter immediately following PUL is challenging and is based on the facility's system, inpatient or outpatient surgery, and anesthesia method. In this study, transient urinary retention occurred in 6 of the 41 patients (14.6%) without a postoperative urinary catheter. In previous reports, 32% of patients required urethral catheterization due to failed voiding trial, with a mean catheterization duration of 0.9 days. Another 45% of patients required urethral catheterization for more than 24 h following PUL. Since these cases were selected due to minimal intraoperative bleeding and preoperative voiding status, further research is warranted to determine the situations in which a postoperative urinary catheter is unnecessary. The ratios of the number of cases with prostate volumes <30, 30 to <50, and ≥50 mL were similar to that of the real‐world data on PUL. The optimal prostate volume for PUL is up to 80 and 70 mL according to the American Urological Association and European Association of Urology guidelines, respectively. , In Japan, a prostate volume up to 100 mL is indicated for PUL. The effects of PUL according to prostate volume and on patients with preoperative urinary retention have been reported in a few studies in Asia. Therefore, in this study, prostate volume was divided into three groups: <30, 30 to <50, and ≥50 mL. In all groups, the postoperative urinary status improved in the PUL group compared to the preoperative status. Since transient urinary retention after PUL was higher in patients with a prostate volume ≥50 mL in the short postoperative period, the appropriate time for removal of the urethral catheter in patients with large prostate volume should be considered. Similarly, no difference was observed in the complications or urethral catheter‐free rate when compared with that of the 30 to <80 mL group, with significant improvement in the urinary status after PUL in the <30 mL prostate volume and ≥80 mL prostate volume groups. The safety of PUL under continuous antiplatelet and anticoagulant medications has also been reported, considering its minimally invasive nature. In this study, perioperative withdrawal of antiplatelet and anticoagulant medications was performed as much as possible based on initial experience, resulting in a small number of cases of PUL under continuous antiplatelet and anticoagulant medications. No significant differences were observed in the perioperative Hb changes between the 16 patients who continued antiplatelet or anticoagulant medications during PUL and the other 144 patients. Adverse events are generally mild to moderate and resolve within 2 weeks. Urinary tract infection is an adverse event following PUL as PUL involves permanent metal implantation; thus, the possibility of infection should be considered. The incidence of urinary tract infection after PUL ranges from 1.0% to 2.8%, which is comparable to that after other BPH interventions. , , In our study, no patients had postoperative fever. Perioperative antibiotics are typically administered for several days. Our study findings suggest that the incidence of urinary tract infection after PUL is low. Another adverse event observed was hemorrhage. No cases of visual field failure attributed to intraoperative hematuria or additional postoperative treatment for hemostasis were observed among patients who received continuous antiplatelet or anticoagulant medication. Only one patient had a pelvic hematoma, warranting prolonged hospital stay and demonstrating complications above Clavien–Dindo grade 2, which improved with conservative treatment. For Japanese patients with BPH who have a narrow pelvic cavity, an initial puncture of the prostate should be performed at a shallow angle of approximately 5°, and an additional 10° angulation should be considered during the second puncture. A high lithotripsy position is crucial during patient positioning to widen the pelvic cavity. In the United States, 46% of 1141 PUL cases were performed under general anesthesia, 30% under local anesthesia, and 25% under twilight anesthesia; 39% (446/1141) of the procedures were performed in clinics, of which 74% (330/446) were performed under local anesthesia. However, in Australia, 99% of the 272 PUL cases were performed under general anesthesia in hospitals. The anesthesia method depends greatly on whether the PUL is performed in a hospital or a clinic. PUL did not require a postoperative catheter in 80% of the patients under local anesthesia. In this study, 78%, 9%, and 13% of the patients underwent PUL under general, lumbar, and local anesthesia, respectively, as all four facilities included in this study were hospitals. The present study had several limitations. First, this was a retrospective study with a short follow‐up period. Therefore, a larger number of cases and a longer postoperative period should be considered. Second, patient selection was based on the guidelines issued by the Japanese Urological Association; thus, a larger proportion of patients were older, had urinary retention, and were taking anticoagulants or antiplatelet medications. Nevertheless, we demonstrated PUL to be a safe and effective procedure in a large number of cases at multiple institutions. In conclusion, these initial case reports in Japan suggest PUL to be a safe and effective technique for both patients with and without preoperative urinary retention with prostate volumes <100 mL. Moreover, we believe that the need for minimally invasive surgeries, such as PUL, will increase in the future in an aging society. However, long‐term postoperative outcomes should be evaluated to confirm the validity of our findings.   Go Anan: Conceptualization; data curation; writing – original draft; writing – review and editing; visualization; project administration; investigation; methodology. Hidero Minami: Conceptualization; data curation; investigation; writing – review and editing; methodology. Yosuke Fujishima: Conceptualization; investigation; writing – review and editing; data curation; methodology. Kanya Kaga: Data curation; conceptualization; investigation; writing – review and editing; methodology.   All authors declare that there are no conflicts of interest.   The protocol for this research project has been approved by a suitably constituted Ethics Committee of the institution, and it conforms to the provisions of the Declaration of Helsinki. Committee of Yotsuya Medical Cube, Tokyo, Japan, Approval No. YCR24001.   Individual consent for this retrospective analysis was waived.   Not applicable.   Not applicable.   