Abstract
Background:
Holmium laser enucleation of the prostate (HoLEP) and robot-assisted simple prostatectomy (RASP) have emerged as the two surgical treatments of medication-refractory benign prostatic hyperplasia (BPH). The comparative outcomes of en-bloc HoLEP with early apical release and RASP with modified Freyer’s technique remain unexplored.
Methods:
Between 2018 and 2022, patients with medication-refractory BPH and prostate volume ≥80 g underwent HoLEP or RASP depending on clinical characteristics, patient choice, and surgeon preference. A 1:1 propensity-matched analysis was performed with prostate volume and preoperative International Prostate Symptom Score (IPSS) as the matching variables to eliminate selection bias. Trifecta outcome was defined as complete urinary continence, Q max >15 mL/second, and no postoperative complications at 3 months. After an initial univariable analysis to predict factors associated with the trifecta outcome, variables with significance levels of ≤0.1 were included in a multivariable model.
Results:
Of 416 patients with medication-refractory BPH, 158 underwent HoLEP, whereas 258 underwent RASP. Following matching, 80 patients in each group were included in the analysis. There was no difference in the median postoperative IPSS score, median postoperative Q max, and continence rate at 3 months. The percentage of patients who attained the trifecta outcome in the HoLEP and RASP groups was 71.25% and 63.75%, respectively (p = 0.4). Patients in the HoLEP group had shorter postoperative stay (HoLEP: 1 [IQR 1–2] vs RASP: 2 [IQR 1–2], p = 0.04) and catheterization time (HoLEP: 2 [IQR 1.75–3] vs RASP: 5 [IQR 5–5], p < 0.001). A multivariable regression did not identify any factors predictive of trifecta outcomes.
Conclusion:
Given its comparable efficacy to RASP, HoLEP is the preferred treatment for BPH in large prostates because of its shorter hospital stay and catheterization time. Future randomized controlled trials are required to solidify indications for these treatment modalities and standardize treatment protocols for patients with medication-refractory BPH.
Introduction
Current guidelines recommend holmium laser enucleation of the prostate (HoLEP) as a viable option for patients with symptomatic benign prostatic hyperplasia (BPH) of all sizes. 1,2 Urologists have transitioned from using a two-lobe technique to en-bloc resection during HoLEP because of faster intraoperative capsule identification and improved postoperative continence after treatment. 3 –5 Despite its efficacy, the steep learning curve for HoLEP has caused many urologists to adopt robot-assisted simple prostatectomy (RASP) for BPH treatment in large prostates (>80 g). 6 RASP is often preferred in patients with concomitant stone disease and large median lobes because of faster operative time and lower incidence of postoperative complications. 1 , 2 , 7
The literature comparing the outcomes of HoLEP and RASP is limited, with prior studies showing varying results. 7 –9 Thus, the comparative efficacy of these two modalities for the treatment of BPH is still disputed. In this study, we explored the outcomes of patients who underwent HoLEP or RASP for the treatment of symptomatic BPH. We performed a propensity-matched analysis to provide a valid comparison of the outcomes of these two techniques. This is the first study to compare en-bloc HoLEP with early apical release and RASP with modified Freyer’s method for the treatment of BPH.
Methods
Study setting, design, and participants
This single-center retrospective study was conducted after Institutional Review Board approval (IRB #UCB7344889/IT). Between January 2018 and December 2022, patients with symptomatic BPH refractory to medical treatment and prostate volume ≥80 g underwent HoLEP or RASP and were included in the study. All the cases of HoLEP or RASP were performed between January 2018 and December 2022. Prior to treatment, patients underwent routine investigations, including postvoid residual measurement, urinalysis, urine culture, and prostate-specific antigen (PSA). Baseline functional status was measured using the International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The choice of treatment modality was decided on a case-to-case basis after considering concurrent bladder issues, patient preference, and surgeon choice. Exclusion criteria were previous endoscopic prostate gland interventions for BPH management and preexisting prostate cancer. All cases were performed by a single surgeon with extensive experience performing both HoLEP and RASP (M.B.).
Surgical technique
Holmium laser enucleation of the prostate
During HoLEP, the Lumenis Pulse™ 120H Holmium Laser System was used with 550 μM laser fiber (MOSES™). An early apical release was performed, and the plane was advanced toward the bladder neck till the enucleation was completed. The morcellation of the enucleated prostate was performed using the Piranha morcellator (Richard Wolf, GmbH, Germany). A 20 Fr catheter was placed at the end of the procedure. Continuous physiologic saline irrigation was given for 6 hours postoperatively to irrigate the bladder. Patients were subsequently evaluated and discharged the same day with the catheter and called into the office the next day for voiding trial. The catheter was usually removed on postoperative day 1 unless there was any concern in terms of ongoing hematuria or need for a longer duration of bladder irrigation.
Robot-assisted simple prostatectomy
RASP was performed using a Da Vinci robotic surgical system (Intuitive Surgical, Sunnyvale, CA). The procedure was performed in the Trendelenburg position. Following pneumoperitoneum creation and port placement, the robot was docked. The bladder was dropped to expose the prostate. The anterior bladder wall was incised just proximal to the prostato-vesical junction, and the bladder neck was incised circumferentially to expose the prostatic adenoma. 7
Prior to enucleation, the internal iliac artery was temporarily clamped on both sides using bulldog clamps as described previously. 10 Prostatic enucleation was performed in the plane between the adenoma and the capsule. Following vesicourethral anastomosis, an 18 Fr Foley catheter was placed. Patients were evaluated and discharged on postoperative day one and were followed up in the clinic after 5 days for a trial of void.
Covariates and study measures
Demographic and operative characteristics such as age, preoperative hemoglobin (Hb), prostate volume, IPSS composite score, SHIM score, preoperative PSA, and operative time were collected. Operative time for HoLEP was recorded from the beginning of LASER enucleation till the end of morcellation and for the RASP as equal to the console time from docking till undocking of the robot. Postoperative variables recorded were postoperative IPSS composite score, Q max, SHIM score, postoperative Hb, time to catheter removal, and incidence of postoperative complications.
The primary study measure was the 3-month trifecta outcome, defined as complete urinary continence + Q max >15 mL/second + no postoperative complications. Continence was defined as the use of 0–1 pads/day.
Statistical analysis
Continuous variables were reported as medians with interquartile ranges, whereas categorical variables were reported as absolute numbers with proportions. The Wilcoxon rank-sum test was used to compare differences in medians between the two groups. Categorical variables were compared using the chi-square test with Pearson corrections. To eliminate potential selection bias, a 1:1 propensity-matching was performed using prostate volume and preoperative IPSS score as matching variables. A nearest-neighbor match was performed using a caliper of 0.1 of the standard deviation of the logit function of the propensity score. The validity of the propensity match was tested by examining the standardized mean difference for the baseline variables after matching. An initial univariable logistic regression was performed to assess factors predicting the trifecta outcome; variables that demonstrated significance levels ≤0.1 were included in a multivariable model to control for confounders. A two-sided p-value of <0.05 was considered statistically significant. The analysis was performed using R programming software version 4.3.2.
Results
Baseline characteristics
Between 2018 and 2022, 416 participants were included in the study; 158 (38%) underwent HoLEP, and 258 (62%) underwent RASP. Prior to matching, statistically significant differences were noted in preoperative urinary retention, prostate size, IPSS score, and preoperative PSA. Following matching, 80 patients were included in each group; no significant differences were noted in baseline characteristics between the two cohorts (Table 1).
Baseline Characteristics of Patients Undergoing Holmium Laser Enucleation of the Prostate and Robot-Assisted Simple Prostatectomy
IPSS = International Prostate Symptom Score; HoLEP = holmium laser enucleation of the prostate; RASP = robot-assisted simple prostatectomy; SHIM = Sexual Health Inventory for Men; SMD = standardized mean difference.
Postoperative outcomes
At 3 months, the median IPSS composite score and the median Q max in the HoLEP and RASP groups were 11 (IQR 9–15) and 12 (IQR 10–15) and 19 mL/second (IQR 16–24) and 20 mL/second (IQR 15.8–23.2), respectively (p = 0.16). The postoperative continence rate at 3 months was 93.8% and 91.25% in the HoLEP and RASP groups, respectively (p = 0.76) (Table 2). Although the trifecta outcomes were better in the HoLEP group than the RASP group (HoLEP: 71.25%; RASP: 63.75%), this difference was not statistically significant (p = 0.4) (Table 3).
Postoperative Outcomes of Patients Undergoing Holmium Laser Enucleation of the Prostate and Robot-Assisted Simple Prostatectomy after Propensity Matching
Outcome measured at 3 months postoperatively.
Trifecta is defined as complete urinary continence + Q max >15 mL/s + no postoperative complications at 3 months.
IPSS = International Prostate Symptom Score; HoLEP = holmium laser enucleation of the prostate; RASP = robot-assisted simple prostatectomy; SHIM = Sexual Health Inventory for Men.
Multivariable Logistic Regression for Factors Predicting Trifecta Outcome After Holmium Laser Enucleation of the Prostate and Robot-Assisted Simple Prostatectomy for the Treatment of Benign Prostatic Hyperplasia
CI = confidence interval; HR = hazard ratio; HoLEP = holmium laser enucleation of the prostate; IPSS = International Prostate Symptom Score; RASP = robot-assisted simple prostatectomy; ASA = American society of anesthesiologist physical status classification.
The intraoperative complications in the RASP group included significant blood loss requiring postoperative transfusions in four patients and small bowel perforation in one patient which was identified intraoperatively and managed by primary repair. In the HoLEP group, we did not encounter any major intraoperative complications. The postoperative Hb, cancer incidence on final pathology, and postoperative complication rates were similar between the two groups. The postoperative complications of the two groups are presented in Table 4. Patients in the HoLEP group had shorter hospital stays (HoLEP: 1 day [IQR 1–2]; RASP: 2 days [IQR 1–2], p = 0.04) and shorter catheterization time (HoLEP: 2 days [IQR 1.75–3]; RASP: 5 days [IQR 5–5], p < 0.001).
Postoperative Complications after Holmium Laser Enucleation of the Prostate and Robot-Assisted Simple Prostatectomy
HoLEP = holmium laser enucleation of the prostate; RASP = robot-assisted simple prostatectomy; UTI = urinary tract infection.
Factors predicting trifecta outcomes
On univariable analysis, preoperative IPSS and preoperative urinary retention were predictive of trifecta outcomes after treatment. This association disappeared when controlling for confounders in the multivariable model. There was no association of the trifecta outcome with the type of treatment.
Discussion
The surgical management of BPH has always been challenging for urologists, with HoLEP and RASP emerging as the two most adopted approaches for large symptomatic prostates in recent times. 10 –15 This is the first study to compare the outcomes of en-bloc HoLEP with early apical release and RASP with modified Freyer’s approach. The two groups were matched for prostate volume and preoperative IPSS score. The findings of our study show that HoLEP and RASP have similar continence and trifecta outcomes at 3 months. In addition, HoLEP patients had faster recovery time and shorter catheterization time.
HoLEP is being increasingly adopted for the surgical treatment of BPH because of shorter operative time, faster recovery, and similar efficacy to simple prostatectomy. 14 –17 The longer learning curve of HoLEP represents a potential limitation of this procedure. 18 , 19 Among the various approaches to HoLEP, the en-bloc technique allows greater observation of the prostate during operation because of the laminar flow of irrigation fluid, leading to decreased laser usage and operative time. 14,16 In a randomized controlled trial (RCT) by Mahajan et al., 5 en-bloc HoLEP was associated with decreased operative time and improved quality-of-life outcomes when compared with the traditional two-lobe technique.
From the prematched cohorts, it is evident that patients with prostates >120 g preferably underwent RASP. Current guidelines recommend both HoLEP and simple prostatectomy for the treatment of medication-refractory BPH; however, there is no clear consensus on specific indications for the two techniques. 1,2 Urologists who perform both these approaches often choose RASP for very large prostates to decrease operative time and prevent the possibility of urethral injuries associated with prolonged endoscopic operation. 19 On the contrary, HoLEP is less invasive than RASP, with virtually no risk of injury to abdominal structures. 15 Transurethral approaches are also known to be associated with faster recovery. 20 This is evident from our study, with HoLEP patients experiencing reduced catheterization time (by 3 days) and earlier discharge from the hospital (by 1 day). The specific indications for HoLEP and RASP are areas of future research, and further studies comparing the two techniques can help standardize treatment protocols in patients with medication-refractory BPH.
Following matching, more than 50% of patients had prostate sizes ranging between 100 and 120 g. The outcomes of our study may be more representative of this population. This must be kept in mind when interpreting our results. We found no difference in continence rates at 3 months between the groups. In addition, although patients in the HoLEP group had a higher incidence of trifecta outcomes (71.25% vs 63.75%), this difference did not reach statistical significance. Studies exploring the outcomes of HoLEP and RASP have been limited. To date, only a single RCT has evaluated the comparative outcomes of HoLEP and RASP, demonstrating that HoLEP has similar functional outcomes to RASP with shorter catheterization time. 21 This study, however, was limited by its small sample size. Other retrospective studies have compared the outcomes of HoLEP and RASP in larger datasets. Zhang et al. found that patients undergoing HoLEP have decreased transfusion rates, shorter hospital stays, and reduced catheterization times, with no difference in postoperative complications, including urinary retention. 17 Grosso et al. found no difference in postoperative functional outcomes after 3 months of treatment with shorter recovery time in patients undergoing HoLEP. 22 The findings of these studies, in addition to our own, endorse HoLEP as the preferred form of treatment for medication-refractory BPH. In contrast, Bove et al. found that patients who undergo RASP had a significantly higher incidence of trifecta outcomes (postoperative Q max >15 mL/second, IPSS <8, and absence of complications) when compared with HoLEP. This study, however, was limited by its smaller sample size and the fact that patients in the two groups followed different postoperative recovery protocols. 23
This study is not without limitations. The retrospective design may have introduced selective bias in the analysis. We performed a 1:1 propensity-matched analysis between the two groups to address this. Following matching, we found that the two groups were similar in terms of baseline characteristics, thus making this comparative analysis valid. In addition, this study was not performed through randomization, and an RCT will be required to truly ascertain the differences in outcomes between HoLEP and RASP. Moreover, as we have measured only short-term postoperative follow-up outcomes, the impact of the residual gland may not be visible so early in the analysis. So we did not include the postoperative PSA data or the volume of the enucleated prostate gland in the analysis, which are otherwise important parameters to study the surgical outcomes.
These limitations notwithstanding, our study is both novel and informative, as it remains the first study to compare en-bloc HoLEP with early apical release and RASP with a modified Freyer’s technique for the treatment of medication-refractory BPH. This study sheds light on an essential aspect of the postoperative outcomes of such patients and makes a case for the adoption of HoLEP for the surgical treatment of BPH.
Conclusion
En-bloc HoLEP with early apical release and RASP (modified Freyer’s approach) are equally efficacious modalities for the surgical management of medication-refractory BPH. HoLEP is associated with a shorter hospital stay and catheterization time. Further RCTs are required to truly ascertain the differences between outcomes after HoLEP and RASP, the findings of which can help guide the standardization of treatment protocols for patients with BPH.
Footnotes
Authors’ Contribution
Conceptualization: M.K.C. and M.B. Methodology: M.B. Formal analysis: K.P.K. Data curation: M.B. Writing—original draft: M.K.C., K.P.K., and A.E. Writing—editing and review: M.K.C., K.P.K., A.E., M.A., N.T., H.S., L.O., A.V., A.R., Z.D., and O.Z. Supervision: M.B.
Data Availability Statement
M.B. takes full responsibility for the authenticity of the data. Data from the study is not publicly available but is available from the authors on reasonable request.
Ethics Statement
The study was approved by the local institutional review board committee; informed consent was waived due to its retrospective nature (IRB #UCB7344889/IT).
Author Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.
