Holmium Laser Enucleation Versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large-Volume Benign Prostatic Hyperplasia: Randomized-Controlled Trial

Abstract

Objectives:

To compare the safety and efficacy of holmium laser enucleation of prostate (HoLEP) vs bipolar plasmakinetic resection of prostate (BPRP) in the management of large-sized (≥75 g) benign prostatic hyperplasia (BPH).

Methods:

This randomized-controlled trial recruited 145 symptomatic BPH patients who had failed medical management, and who had undergone either HoLEP (Versa pulse^® 100 W; n = 73) or BPRP (AUTOCON^® II 400 ESU; n = 72). Both groups were compared using the Mann–Whitney, chi-square, Student-t, or Fisher exact tests as appropriate. Preoperative vs postoperative findings (24 months) were compared using paired t-test or Wilcoxon signed-rank test.

Results:

The two groups were comparable for most preoperative findings including prostate size (p = 0.629), although HoLEP included more patients on anticoagulants (p = 0.001). HoLEP was associated with significantly less operative duration (p < 0.001), hemoglobin loss (p < 0.001), catheterization duration (p = 0.009), and hospital stay (p < 0.001). There was no significant difference in total complications (p = 0.291) and each separate complication. Blood transfusion was reported only with BPRP (p = 0.058). At 24 months of follow-up, there was significant improvement in all the parameters in each group (International Prostate Symptom Score [IPSS], maximum urinary flow rate [Q_max]_, quality of life [QoL], and postvoid residual urine [PVRU]; p < 0.001). There was no significant difference between both groups in postoperative IPSS (p = 0.08), Q_max (p = 0.051), QoL (p = 0.057), or PVRU (p = 0.069). There was significantly better percentage improvement of both IPSS (p = 0.006) and QoL (p = 0.025) in HoLEP. HoLEP and smaller removed (resected or enucleated) tissues were associated with a reduction in the primary outcomes (hemoglobin loss and operative duration) in logistic regression analysis.

Conclusion:

HoLEP showed better safety profile with significantly less operative duration, hemoglobin loss, hospital stay, and catheterization duration. Although both procedures were effective, HoLEP showed significantly better percentage improvement of both IPSS and QoL. ClinicalTrials.gov Identifier: NCT04143399.

Introduction

Transurethral resection of the prostate (TUR-P) remains a gold standard for the management of benign prostatic hyperplasia (BPH) associated with moderate to severe lower urinary tract symptoms (LUTS). However, new techniques are developed continuously to overcome the complications, drawbacks, and limitations that were reported with TUR-P especially for large-sized prostates. Of these techniques, holmium laser enucleation of prostate (HoLEP) and bipolar transurethral plasmakinetic resection of the prostate (bipolar plasmakinetic resection of prostate [BPRP]) are commonly used. They have a significantly better morbidity profile when compared with TUR-P or open prostatectomy.^1

–6

Although each of the two techniques was thoroughly compared in literature vs the standard TUR-P, the randomized-controlled trials (RCTs) that compared directly HoLEP vs BPRP are still scarce.^7
–9 Furthermore, these few studies were mostly of short term or/and recruited patients with small/medium-sized prostates. Therefore, the aim of the present study was to compare the 2-year safety and efficacy of HoLEP vs BPRP in the management of LUTS associated with large-sized BPH.

Methods

Patients presenting with failure of medical treatment for moderate to severe LUTS resulting from large-sized prostate (≥75 g) in the outpatient clinics in our tertiary center during the period from February 2016 to May 2017 were recruited in this RCT. Inclusion criteria were an International Prostate Symptom Score (IPSS) >13 and a maximum urinary flow rate (Q_max) <15 mL/second. Patients with bladder calculus, cancer, previous prostate surgery or urethral stricture, neurogenic bladder, or severe cardiopulmonary diseases were excluded.

Preoperative evaluation included IPSS together with its portion concerned with quality of life (IPSS-QoL), prostate specific antigen (PSA), coagulation profile, complete blood count, creatinine, electrolytes, urine analysis and culture, Q_max, and postvoid residual urine (PVRU) using ultrasound. Transrectal ultrasound (TRUS) was used to measure the prostate volume with or without biopsy as indicated. If a biopsy was taken, the surgery was not performed till passage of 4 weeks to avoid as possible any sequelae on the plane of dissection.

A written informed consent was obtained from all patients after approving the study by the local ethics committee.

Patients were randomized (block randomization) into two groups according to the computer-generated list, which was performed by an independent statistician. Allocation concealment was done using sealed identical envelopes that were opened at the time of surgical procedure. Patients in group A were treated by HoLEP (Versa pulse^® 100 W; Lumenis) using 550 μm laser fibers and 26F continuous flow resectoscope with a modified bridge to hold the laser fiber (Storz, Tuttlingen, Germany). The setting was adjusted to 2 J to 50 Hz (100 W) for enucleation, but 1.5 J to 30 Hz for hemostasis. The laser setting was reduced again to 1.5 J to 30 Hz during detachment of the adenoma at sphincter area to reduce as possible postoperative incontinence. Enucleation was followed by transurethral morcellation (VersaCut) through 26F nephroscope. Enucleation was performed in most patients using the three-lobe technique. The decision was dictated by the individual anatomy and surgeon preference. HoLEP started with enucleation of the median lobe by performing two deep incisions reaching the capsule at 5 and 7 o'clock positions extending from the bladder neck to the level of verumontanum. Then, the median lobe was dissected in a retrograde manner followed by each lateral lobe starting from 5 and 7 o'clock incisions, and then progressing anteriorly. The final step was a longitudinal incision at 12 o'clock reaching the capsule to separate the two lateral lobes.

Patients in group B were treated by BPRP using 26F continuous flow bipolar resectoscope (Karl Storz) with the generator (AUTOCON^® II 400 ESU). Power output was set at 5 for resection and 6 for coagulation. The BPRP was performed similar to the classic surgical steps of monopolar TUR-P. The middle lobe was resected initially and then followed by the lateral lobes.

The two procedures were performed by the same surgeon who was experienced in them. Both procedures were performed while the patients were in the lithotomy position under spinal/epidural anesthesia. Prophylactic third-generation cephalosporin (1 g) was given for all patients. Physiologic saline was used for irrigation at a height of 60 cm. If patients were on anticoagulants (AC), they were replaced by low-molecular-weight heparin (LMWH). LMWH was discontinued 12 hours before the procedure. For antiplatelets (AP), aspirin was not discontinued while management of patients on clopidogrel was decided according to the discussion between the surgeon and the anesthetist, taking into consideration the indications of clopidogrel in each patient. Subsequently, clopidogrel was discontinued in most cases for 5 days before the procedure with or without replacement by LMWH. Hemoglobin was measured immediately after each procedure. Bladder irrigation was continued postoperatively till resolution of hematuria. The catheter was removed when the urine remained clear after cessation of irrigation. This was followed by discharge of patients if they voided freely.

Follow-up was performed at 1, 6, 12, 18, and 24 months after surgery. During follow-up, both patients and physicians were blinded to the line of treatment. In each visit, urine analysis and culture (when indicated), IPSS, QoL, Q_max, PSA, and PVRU were assessed.

Perioperative data, including operative duration, hemoglobin loss (primary outcomes), catheterization duration, hospital stay, and complications, were compared between both groups using the Mann–Whitney or Student-t tests for continuous data and chi-square or Fisher exact tests for categorical data. Pre- vs postoperative findings (24 months) were compared in each group using Wilcoxon signed-rank test or paired t-test. The analysis was intention-to-treat and involved all patients. Logistic regression analysis was performed to detect risk factors for hemoglobin loss and for prolonged operative duration; the dependent variable was presented as a categorical value whether less or more than the median level of hemoglobin loss or operative duration for all patients. The Statistical Package of Social Science Software program (SPSS), version 20, was used. p < 0.05 was considered statistically significant.

The sample size was calculated based on the hemoglobin loss that was reported in the previous studies that compared HoLEP vs BPRP^7
–9; as 1.08 ± 0.53 vs 1.32 ± 0.65 g/dL.⁷ Using Student-t test with an 80% power, 5% α-error level and 1:1 allocation ratio, the calculated sample size was 69 patients in each group. As operative duration and hospital stay were also important outcomes, the sample size was calculated for them according to the same previously mentioned studies.^7
–9 Their calculated sample size was smaller than that calculated for hemoglobin loss; consequently, the sample size for hemoglobin loss fulfilled the three outcomes. We increased the number of patients by 5% to compensate for any missed patients during follow-up; thus, the sample size was 73 patients in each group. Calculations were done using PS Power and Sample Size Calculations Software, version 3.0.11 for MS Windows (William D, Dupont and Walton D. Vanderbilt).

Results

All patients completed the study except one patient in BPRP who refused to perform the procedure after initial consent (Fig. 1). Although patients were properly randomized, HoLEP included more patients on AP/AC (32.9% vs 9.7%, p = 0.001). There was no significant difference in other baseline characteristics, including age, preoperative retention, prostate size, hemoglobin, sodium, IPSS, Q_max, QoL, PVRU, PSA, and preoperative biopsy (Tables 1 and 2).

FIG. 1.

Consolidated standards of reporting trials diagram.

Table 1.

Baseline Characteristics in Both Groups

	HOLEP group, 73 patients	BPRP group, 72 patients	p
Age (years)	65.95 ± 6.76 (51–76)	65.59 ± 6.72 (50–76)	0.74
UR	30 (41.1%)	34 (47.2%)	0.45
Residual urine (mL)	155.4 ± 120.3 (24–470)	161.36 ± 107.68 (20–410)	0.78
Patients on AC	24 (32.9%)	7 (9.7%)	0.001^a
Preoperative TRUS biopsy	19 (26%)	17 (23.6%)	0.73
Operative duration (minutes)	71.73 ± 25.44 (50–160)	88.44 ± 16.06 (59–140)	<0.001^a
Prostate size (cc)	105.8 ± 46.12 (76–295)	102.95 ± 19.69 (76–173)	0.62
Removed tissues (g)^b	81.98 ± 43.26 (50–252)	62.77 ± 15.92 (38–126)	0.001^a
Preoperative Hb (g/dL)	13.86 ± 1.31 (10.3–16.5)	13.65 ± 1.78 (11–16.4)	0.406
Postoperative Hb (g/dL)	13.53 ± 1.32 (10–16.3)	12.02 ± 1.56 (8.5–15.1)	<0.001^a
Hb loss (g/dL)	0.337 ± 0.335 (0–1.7)	1.3 ± 0.64 (0.4–3.5)	<0.001^a
Hospital stay (hours)	19.73 ± 5.67 (14–48)	27.25 ± 7.71 (19–54)	<0.001^a
CD (hours)	18.2 ± 10.07 (12–96)	28.48 ± 31.12 (17–240)	0.009^a
Preoperative Na (mmol/L)	141.93 ± 1.78 (138–146)	141.66 ± 3.62 (134–150)	0.57
Postoperative Na (mmol/L)	141.24 ± 2.3 (136–146)	141.31 ± 3.68 (133–156)	0.88
Complications	13 (17.8%)	18 (25%)	0.29
Grade 1
Morcellator malfunction	1 (1.4%)	—	—
Retention of urine	0	0	—
Capsule perforation	0	1 (1.4%)	0.49
Grade 2
BT	0	4 (5.6%)	0.058
Epididymo-orchitis	1 (1.4%)	1 (1.4%)	1
Transient incontinence	9 (12.3%)	7 (9.7%)	0.61
UTI	7 (9.6%)	6 (8.3%)	0.79
Grade 3
Second look	0	0	-
Stricture urethra	1 (1.4%)	1 (1.4%)	1
Recurrence	0	0	-

Data are presented as number (%) or mean ± SD (range) as appropriate.

Significant.

Removed tissues by enucleation or resection.

AC = anticoagulants; BPRP = bipolar transurethral plasmakinetic resection of prostate; BT = blood transfusion; CD = catheterization duration; Hb = hemoglobin; HoLEP = holmium laser transurethral enucleation of prostate; SD, standard deviation; TRUS = transrectal ultrasound; UR = urinary retention; UTI = urinary tract infection.

Table 2.

Follow-Up Parameters for Both Groups

	HOLEP group, 73 patients	BPRP group, 72 patients	p
IPSS
Preoperative	26.53 ± 4.29 (18–34)	25.4 ± 2.91 (20–31)	0.06
Postoperative (24 months)	6.09 ± 2.8 (1–12)	6.83 ± 2.19 (3–15)	0.08
P	<0.001^a	<0.001^a
Improvement (24 months)	20.43 ± 3.92 (13–29)	18.56 ± 3.19 (9–25)	0.002^a
% Improvement (24 months)	77.2 ± 9.43 (52–96.15)	72.99 ± 8.7 (37.5–86.96)	0.006^a
Q_max (mL/second)
Preoperative	4.54 ± 3.65 (0–11)	4.7 ± 3.43 (0–12)	0.78
Postoperative (24 months)	23.03 ± 3.37 (17–30)	21.79 ± 4.19 (16–29)	0.051
P	<0.001^a	<0.001^a
Improvement (24 months)	18.49 ± 4.11 (10.5–29)	17.08 ± 4.52 (9.8–29)	0.051
% Improvement (24 months)	337.3 ± 238.5 (100–1252)	319.7 ± 289.1 (100–1800)	0.73
QoL
Preoperative	5 (3–6)	4 (3–6)	0.69
Postoperative (24 months)	2 (0–3)	2 (1–3)	0.057
P	<0.001^a	<0.001^a
Improvement (24 months)	3 (1–6)	3 (1–5)	0.17
% Improvement (24 months)	68.79 ± 15.36 (25–100)	62.17 ± 14.04 (25–83.33)	0.025^a
PSA (ng/mL)
Preoperative	7.6 ± 4.19 (2.2–19)	7.56 ± 3.56 (2.8–17)	0.95
Postoperative (24 months)	1.69 ± 0.99 (0.1–3.8)	3.31 ± 1.12 (1.2–5.3)	<0.001^a
P	<0.001^a	<0.001^a
Improvement (24 months)	5.91 ± 3.46 (1.9–15.9)	4.25 ± 2.66 (0.1–12.1)	0.002^a
% Improvement (24 months)	78.01 ± 8.71 (56.25–96.54)	53.07 ± 11.7 (3.57–74.38)	<0.001^a
PVRU (mL)
Preoperative	155.4 ± 120.3 (24–470)	161.36 ± 107.68 (20–410)	0.78
Postoperative (24 months)	22.32 ± 16.28 (0–70)	28.33 ± 22.64 (0–80)	0.06
P	<0.001^a	<0.001^a

Data are presented as median (range) or mean ± SD (range) as appropriate.

Significant.

IPSS = International Prostate Symptom Score; PSA = prostate specific antigen; PVRU = postvoid residual urine; Q_max = maximum urinary flow rate; QoL = quality of life.

HoLEP was associated with significantly less operative duration (p < 0.001), hemoglobin loss (p < 0.001), catheterization duration (p = 0.009), and hospital stay (p < 0.001), although it was associated with a larger amount of removed tissues (p = 0.001) (Table 1).

There was no significant difference between both groups in total complications (17.85 vs 25%; p = 0.291), capsular perforation (p = 0.497), epididymo-orchitis (p = 1), transient urinary incontinence (p = 0.616), urinary tract infection (UTI; p = 0.791), or stricture urethra (p = 1); however, blood transfusion was reported only with BPRP (p = 0.058). There were no reported cases of postoperative urinary retention, postoperative bleeding requiring clot evacuation, morcellation injury to the bladder, TUR syndrome, or cases of recurrence (Table 1).

Capsular perforation was managed by prolongation of catheterization up to 7 days. Urinary incontinence was transient in all patients and relieved by anticholinergics and/or pelvic floor muscle exercises within 4 months postoperatively. Patients with postoperative UTI were managed according to culture. Cases with stricture urethra were treated with urethral dilatation (one case) or visual internal urethrotomy (one case).

At 24 months of follow-up, there was significant improvement in all parameters in each group (IPSS, Q_max, QoL, and PVRU; p < 0.001). There was no significant difference between both groups in postoperative IPSS (p = 0.08), Q_max (p = 0.051), QoL (p = 0.057), or PVRU (p = 0.069) (Table 2). However, significantly better IPSS improvement (p = 0.002), percentage improvement of IPSS (p = 0.006), and percentage improvement of QoL (p = 0.025) were reported in HoLEP (Table 2). Furthermore, the preoperative/postoperative PSA difference was significantly better in HoLEP (p = 0.002) (Table 2).

Logistic regression analysis revealed that hemoglobin loss (Table 3) and operative duration (Table 4) were significantly less with relatively smaller removed (resected or enucleated) tissues or when using HoLEP. However, they were not affected by preoperative prostate biopsy or use of AC/AP.

Table 3.

Logistic Regression Analysis for Risk Factors Affecting Hemoglobin Loss in All Patients

	p	OR	95% CI for OR
	p	OR	Lower	Upper
AC	0.915	0.935	0.271	3.227
Preoperative TRUS biopsy	0.075	2.676	0.904	7.918
Removed tissues^a	0.004^b	1.021	1.007	1.035
Group (HoLEP vs BPRP)	<0.001^b	0.005	0.001	0.023

Removed tissues by resection or enucleation.

Significant.

CI = confidence interval; OR = odds ratio.

Table 4.

Logistic Regression Analysis for Risk Factors Affecting Operative Time in All Patients

	P	OR	95% CI for OR
	P	OR	Lower	Upper
AC	0.304	0.306	0.032	2.926
Preoperative TRUS Biopsy	0.252	0.478	0.135	1.691
Removed tissues^a	<0.001^b	1.196	1.114	1.285
Group (HoLEP vs BPRP)	<0.001^b	0.001	<0.001	0.019

Removed tissues by resection or enucleation.

Significant.

Discussion

Direct comparative studies of BPRP vs HoLEP are still scarce and they are either of short term (6–12 months)^8,9 or recruited small- to medium-sized prostates (Tables 5 and 6).^7
–9 Only one study¹⁰ presented the long-term results of a study by Chen and colleagues.⁷ Thus, the present study was the first comparing HoLEP vs BPRP in only patients with large-sized prostates (>75 g). In addition, it did not exclude patients on AC/AP, which were excluded from previous studies.^7
–9

Table 5.

Previous Comparative Trials of Holmium Laser Transurethral Enucleation of Prostate vs Bipolar Plasmakinetic Transurethral Resection of Prostate: Perioperative Data and Inclusion Criteria

Study	Inclusion criteria	S	Arms of study	Size (TRUS; cc)	Op-time (minutes)	Hb drop (g/dL)	CD hour	Hospital stay
Chen and colleagues⁷	IPSS >8, Q_max < 16, QoL >2, PVRU ≥50, RCT	M	HoLEP (140 patients)	56.7 ± 28.4	86.5 ± 31.4	1.08 ± 0.53	79.2 ± 22.7	3.5 ± 1.2 Days
			BPRP (140 patients)	60.3 ± 22.4	60.3 ± 20.8	1.32 ± 0.65	85.1 ± 26.3	4.3 ± 1.4 Days
			P	0.24	<0.01^a	<0.01^a	<0.05^a	<0.01^a
Fayad and colleagues⁸	IPSS >7, Q_max < 16, BPH >20 g, RCT	M	HoLEP (30 patients)	76.5 ± 17.2 (45–110)	110.5 ± 28.8		24	49 ± 5.8 Hours
			BPRP (30 patients)	80.6 ± 17.7 (55–120)	76.5 ± 19.8	—	24	48 Hours
			p	0.36	<0.001^a		>0.05	>0.05
Fayad and colleagues⁹	IPSS >7, Q_max < 15, BPH >20 g, RCT	M	HoLEP (60 patients)	68.1 ± 11.1	96.1 ± 24.8	More drop in BPRP <0.001^a	Prolonged in BPRP due to hematuria	Prolonged in BPRP due to hematuria
			BPRP (60 patients)	67.2 ± 9.7	81.2 ± 11.8		Prolonged in BPRP due to hematuria	Prolonged in BPRP due to hematuria
			BPRP (60 patients)	67.2 ± 9.7	81.2 ± 11.8		—	—
			p	—	<0.001^a		—	—
Present study	IPSS ≥13, Q_max < 15, BPH >75 g, MF, RCT	M	HoLEP (73 patients)	105.8 ± 46.12 (76–295)	71.7 ± 25.4 (50–160)	0.33 ± 0.33 (0–1.7)	18.2 ± 10 (12–96)	19.7 ± 5.6 (14–48)
			BPRP (72 patients)	102.9 ± 19.6 (76–173)	88.4 ± 16.06 (59–140)	1.3 ± 0.64 (0.4–3.5)	28.4 ± 31.1 (17–240)	27.2 ± 7.7 (19–54)
			p	0.62	<0.001^a	<0.001^a	0.009^a	<0.001^a

Data presented as mean ± SD.

Significant.

BPH = benign prostatic hyperplasia; BPRP = bipolar plasmakinetic resection of prostate; M = multiple; MF = medical failure; Op-time = operative duration; RCT = randomized-controlled trial; S = number of surgeons.

Table 6.

Previous Comparative Trials for Holmium Laser Enucleation of Prostate vs Bipolar Plasmakinetic Resection of Prostate: Resected Tissues and Complications

Study	Arms of study	Follow-up (months)	Removed tissue (g)^a	BT %	UR %	UTI %	UI %	BNC/US %	CP %	Notes
Chen and coworkers⁷	HoLEP (140 patients)	24	48.5 ± 25.4	0	0		9.28	0.71		Morcellator; used for HoLEP; AC excluded
	BPRP (140 patients)		41 ± 16.1	0.71	1.4	—	2.85	1.4	—
	P		<0.01^b	—	—		—	—
Gu and coworkers^10,c	HoLEP (122 patients)	72	—	—	—	—	9.28	0.71	—
	BPRP (119 patients)						2.85	1.4
	P						—	—
Fayad and coworkers⁸	HoLEP (30 patients)	6	55.9 ± 14.7	0	3.3	—	—	0	—	Morcellator; used for HoLEP; AC excluded; UR recruited
	BPRP (30 patients)		65.6 ± 16.1	0	0			0
	p		0.018^b	—	—			—
Fayad and coworkers ⁹	HoLEP (60 patients)	12	61.1	0	15		6.6	0		Morcellator; used for HoLEP; AC excluded; UR recruited
	BPRP (60 patients)		58.8	3.3	3.3	—	8.3	6.6	—
	P		>0.05	0.49	—		—	—
Present Study	HOLEP (73 patients)	24	81.9 ± 43.2 (50–252)	0	0	9.6	12.3	1.4	0	AC recruited; UR recruited; morcellator; used
	BPEP (72 patients)		62.7 ± 15.9 (38–126)	5.6	0	8.3	9.7	1.4	1.4
	P		0.001^b	0.05	—	0.79	0.61	1	0.49

Data presented as number, percentage, or mean ± SD (range) as appropriate.

Removed tissues by resection or enucleation.

Significant.

Gu and coworkers' study¹⁰ is a long-term follow-up of the Chen and coworkers' study.⁷

BNC/US = bladder neck contracture/urethral stricture; BPEP = bipolar enucleation of prostate; CP = capsular perforation; UI = urinary incontinence.

In the previous direct comparative studies, both techniques were effective with no significant difference between both groups in postoperative IPSS, Q_max, or PVRU.^7,8 However, the long-term follow-up (up to 6 years) showed significantly better Q_max and IPSS in HoLEP when compared with BPRP.¹⁰ In the present study, both techniques were effective, but HoLEP showed a significantly better IPSS drop and percentage improvement of both IPSS and QoL when compared with BPRP. This better improvement in IPSS and QoL was not related only to the type of used energy whether holmium laser or bipolar, but was also related to the technique itself whether enucleation or resection. This was proven in the meta-analysis that included 14 studies comparing bipolar enucleation of prostate (BPEP) vs BPRP, which reported a lower IPSS, a higher Q_max, and a lower PVRU in the enucleation group compared with the resection group although both techniques used the bipolar energy.¹¹

In the present study, HoLEP removed a larger amount of prostate tissues similar to the previous studies,^7
–9 and was associated with a lower postoperative PSA.⁷ Furthermore, this was reflected on the long-term rate of recurrence according to Gu and coworkers who reported two patients requiring reoperation for recurrence of BPH within 6 years. Both of them were in the BPRP group.¹⁰ The reported explanation was that the enucleation along the surgical capsule minimized the residual prostate tissue and the rate of relapse.¹⁰ Similarly, Arcaniolo and colleagues reported in their meta-analysis that BPEP had a higher amount of resected tissue and lesser postoperative PSA than BPRP, confirming again that these results may be related to the used technique rather than the type of energy.¹¹ In a retrospective study, it was reported that HoLEP removed a significantly higher percentage of tissues in relation to preoperative prostate volume (63.5% vs 49.5%) when compared with BPRP.¹² On the contrary, there was no significant difference in removed tissue weight in a recent RCT that compared HoLEP vs BPEP.¹³ We did not report any case with recurrence in the present study, which may be explained by the limited follow-up (24 months). A longer follow-up period up to 5 to 6 years may be required to confirm or to exclude any difference in the recurrence rate.

The operative duration was longer with BPRP, which was different than the previous three studies that reported a shorter operative duration with BPRP. This may be explained by recruitment of small/medium-sized prostates in those studies.^7
–9 In a previous RCT (155 patients in each group), BPEP had a longer operative duration than BPRP for prostate volume ≤60 mL, this was reversed for prostate volume >60 mL as BPEP reduced operative duration and caused less blood loss. Thus, the benefits of enucleation technique appeared in the subgroup of large prostates.¹⁴ This was confirmed in the present study in the regression analysis, which detected HoLEP and less removed (resected or enucleated) tissues as significant factors predicting reduced operative duration. Furthermore, in a recent RCT for management of large-sized BPH (>80 g), the operative duration was significantly shorter in HoLEP compared with BPEP.¹³

Similar to the previous studies, there were no reported cases of TUR syndrome^7
–9 nor a significant reduction in postoperative sodium⁷ in the present study.

In the present study, HoLEP showed a significantly less drop of hemoglobin and subsequently, less catheter duration and hospital stay. The difference in hemoglobin drop was clinically significant and was reflected on the rate of blood transfusion. This was similar to the previous studies (Tables 5 and 6) that reported no blood transfusion with HoLEP,^7
–9 while it was reported with BPRP in two studies.^7,9 The reduced blood loss with HoLEP was not related only to the use of holmium but also to the technique of enucleation. Luo and colleagues recorded less blood loss with BPEP compared with BPRP in an RCT.¹⁴ Furthermore, BPEP showed less bleeding, catheter duration, hemoglobin drop, and hospital stay compared with BPRP in the meta-analysis of Arcaniolo and coworkers¹¹ This was explained by the fact that blood vessels are opened at one level (capsule) during enucleation, but at multiple levels during resection.⁷ Although a proper randomization was done, we reported a higher rate of patients on AC/AP in HoLEP in the present study. However, this did not affect the results but confirmed the better safety profile of HoLEP, which was associated with less hemoglobin drop than BPRP in the presence of a higher rate of patients on AC/AP. In addition, blood transfusion was reported only in BPRP. This was confirmed in the regression analysis, which detected HoLEP and less removed tissues as significant factors predicting reduced hemoglobin loss. However, a subgroup analysis for patients on AC/AP could not be performed due to the small number of patients on AC/AP. On the contrary, preoperative TRUS biopsy and use of AC were nonsignificant in the same regression analysis. We observed this clinically as the presence of preoperative biopsy was not associated with any difficulty during transurethral manipulation. However, we did not find any published data on the effect of preoperative biopsy on subsequent resection or enucleation. Recently, we reduced gradually this period between biopsy and subsequent transurethral intervention.

Similar to previous studies,^7
–9 both techniques were safe. There was no significant difference in urinary incontinence. In addition, it was transient and relieved completely 4 months postoperatively. Chen and associates reported a higher rate of postoperative incontinence in HoLEP (9.28%) compared with BPRP (2.85%).⁷ Furthermore, there was no significant difference in urinary incontinence in a recent RCT that compared HoLEP vs BPEP,¹³ while Luo and colleagues reported a higher rate after BPEP compared with BPRP.¹⁴ All cases of incontinence in these studies were transient and recovered within few months. Thus, postoperative urinary incontinence may be related to the type of used technique (enucleation vs resection) rather than the type of energy. In the present study, there was no significant difference in the rate of urethral stricture/bladder neck contracture (BNC). Similarly, Chen and coworkers reported urethral stricture/BNC in 2 (1.4%) patients in BPRP and in 1 (0.71%) patient in HoLEP.⁷ Furthermore, there was no difference between the 2-year and 6-year follow-up in the rate of urethral stricture/BNC in both techniques, confirming long-term safety.¹⁰ On the contrary, Fayad and colleagues reported postoperative urethral stricture/BNC only in the BPRP group.⁹ We did not report postoperative urinary retention in any case; however, Chen and coworkers reported postoperative urine retention in 2 (1.4%) patients in the BPRP group.⁷ In another study, only one case was reported, which was in HoLEP.⁸ In the third study, postoperative urinary retention was higher in HoLEP (15% vs 3.3%).⁹

The present study was unique in recruiting patients on AC/AP. In addition, it focused only on patients with large-sized prostate (>75 g), which helped in clarifying the benefits of HoLEP in the management of this large size. However, the present study had limitations. Although the follow-up (24 months) was longer than other studies,^7
–9 it was still not long term. Furthermore, there was no cost analysis.

In conclusion, HoLEP showed a better safety profile and better efficacy compared with BPRP for the treatment of moderate to severe LUTS in patients with large BPH (>75 g). Although significantly more patients on AC/AP were present in HoLEP, it showed less operative duration, hemoglobin loss, hospital stay, and catheterization duration than BPRP. In addition, blood transfusion was reported only with BPRP. Furthermore, HoLEP showed slightly better percentage improvement in IPSS and QoL.

Ethical Approval

All procedures performed were in accordance with the ethical standards of our institutional research committee (ethics committee approval: 62513) and with the 1964 Helsinki Declaration and its later amendments. A written informed consent was obtained from all patients.

Footnotes

Data Statement

The data sets generated and/or analyzed during the present study are not publicly available but are available from the corresponding author on reasonable request.

Author Disclosure Statement

The authors declare that they have no conflict of interest.

Funding Information

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Abbreviations Used

References

Starkman

, Santucci

. Comparison of bipolar transurethral resection of the prostate with standard transurethral prostatectomy: Shorter stay, earlier catheter removal and fewer complications. BJU Int, 2005; 95:69–71.

Bhansali

, Patankar

, Dobhada

, et al. Management of large (>60 g) prostate gland: PlasmaKinetic Superpulse (bipolar) versus conventional (monopolar) transurethral resection of the prostate. J Endourol, 2009; 23:141–145.

Tan

, Gilling

, Kennett

, et al. A randomized trial comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for the treatment of bladder outlet obstruction secondary to benign prostatic hyperplasia in large glands (40 to 200 grams). J Urol, 2003; 170:1270–1274.

Montorsi

, Naspro

, Salonia

, et al. Holmium laser enucleation versus transurethral resection of the prostate: Results from a 2-center, prospective, randomized trial in patients with obstructive benign prostatic hyperplasia. J Urol, 2004; 172:1926–1929.

Lin

, Wu

, Xu

, et al. Transurethral enucleation of the prostate versus transvesical open prostatectomy for large benign prostatic hyperplasia: A systematic review and meta-analysis of randomized controlled trials. World J Urol, 2016; 34:1207–1219.

Rao

, Yang

, Ren

, et al. Plasmakinetic enucleation of the prostate versus transvesical open prostatectomy for benign prostatic hyperplasia >80 mL: 12-month follow-up results of a randomized clinical trial. Urology, 2013; 82:176–181.

Chen

, Chen

, Wang

, et al. A prospective, randomized clinical trial comparing plasmakinetic resection of the prostate with holmium laser enucleation of the prostate based on a 2-year followup. J Urol, 2013; 189:217–222.

Fayad

, Sheikh

, Zakaria

, et al. Holmium laser enucleation versus bipolar resection of the prostate: A prospective randomized study. Which to choose?. J Endourol, 2011; 25:1347–1352.

Fayad

, Elsheikh

, Zakaria

, et al. Holmium laser enucleation of the prostate versus bipolar resection of the prostate: A prospective randomized study. “Pros and cons.”. Urology, 2015; 86:1037–1041.

10.

, Chen

, Liu

, et al. Comparison of holmium laser enucleation and plasmakinetic resection of prostate: A randomized trial with 72-month follow-up. J Endourol, 2018; 32:139–143.

11.

Arcaniolo

, Manfredi

, Veccia

, et al. Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: An ESUT systematic review and cumulative analysis. World J Urol, 2020; 38:1177–1186.

12.

Rosenhammer

, Lausenmeyer

, Mayr

, et al. HoLEP provides a higher prostate cancer detection rate compared to bipolar TURP: A matched-pair analysis. World J Urol, 2018; 36:2035–2041.

13.

Habib

, Ayman

, ElSheemy

, et al. Holmium laser enucleation vs bipolar plasmakinetic enucleation of a large volume benign prostatic hyperplasia: A randomized controlled trial. J Endourol, 2020; 34:330–338.

14.

Luo

, Shen

, Guan

, et al. Plasmakinetic enucleation of the prostate vs plasmakinetic resection of the prostate for benign prostatic hyperplasia: Comparison of outcomes according to prostate size in 310 patients. Urology, 2014; 84:904–910.