Initial safety and efficacy of holmium laser enucleation

of the prostate: Real world evidence from a tertiary centre

Sailantra Sivathasan ^1*, Lit Kiat Tan ^1*, Brayan Samuel ², Chandrarajan Shah ³, Chigozie Onyeze ¹, Amit Kalpee ^{1, 2}

1 NHS Tayside Ninewells Hospital;

2 University of Dundee;

3 NHS Lothian Western General Hospital.

* Joint first authors.

 

Summary

Objective: This study aims to evaluate the initial safety and efficacy of Holmium enucle-

resection of the Prostate (TURP), particularly in patients with severe or resistant symptoms (1). However, in recent

ation of the prostate (HoLEP) in managing benign prostatic hypertrophy (BPH) in a single tertiary centre.

Materials & methods :A retrospective cohort study was conduct-ed focusing on a single tertiary hospital in which data was col-lected from electronic medical records which includes demo-graphic information, preoperative characteristics, surgical details, and post-operative outcomes; complications were classi-fied using the Clavien-Dindo classification.

Results: 104 patients with BPH and lower urinary tract symp-toms (LUTS) were analysed in this study, with a mean prostate volume of 109.3 ± 47.2 ml. The mean change in post void resid-ual volume (PVR) was (-)75%, whilst the mean change in maxi-mum fiow rate (QMax) was (+)109%. 21/104 (19%) patients presented with post-operative complications, the majority of these (13) were Grade I complications with three patients being Grade III. Increasing age (p = 0.014) was shown to have con-tributed to complications. Pre-operative anticoagulation was shown to yield no significance (p = 0.066).

Conclusion: HoLEP remains a viable treatment modality for BPH especially in larger prostates (> 100 ml). However, consid-erations regarding post-operative outcomes should be taken when offering this treatment to more elderly patients.

Additionally, HoLEP provides a good treatment option for patients on anticoagulation.

Key words: HoLEP; Benign Prostatic Hyperplasia (BPH); Low Urinary Tract Symptoms (LUTS).

Submitted ; Accepted

Introduction

Bladder outlet obstruction caused by benign prostatic hypertrophy (BPH) is a common urological condition that causes lower urinary tract symptoms (LUTS) in men and significantly affects their quality of life (1). According to the established guidelines on management of non-neuro-genic male LUTS, management of symptoms due to BPH are divided into conservative, pharmacological, and sur-gical management (1).

Surgical management of bladder outlet obstruction (BOO) and LUTS is historically managed with Transurethral

years new techniques were developed to rival the safety and efficacy of TURP.

Holmium LASER Enucleation of the Prostate (HoLEP) is one surgical technique developed for the management of BPH which has been described in literature to rival TURP (3); it utilizes a holmium LASER to enucleate prostatic tissue. Current literature suggests this approach to be effective, particularly in patients with large prostates (> 80 ml). HoLEP is associated with reduced perioperative morbidi-ty, including lower rates of bleeding, shorter catheteriza-tion times, and quicker recovery (4, 5).

This study evaluates the initial safety and efficacy of HoLEP in patients with BPH in a single training tertiary centre hospital, focusing on early functional outcomes, complication rates, and the impact of specific patient fac-tors, including age and anticoagulant use. By providing a comprehensive analysis of perioperative and postopera-tive outcomes, this study seeks to contribute to the grow-ing body of evidence supporting HoLEP as a valid first line surgical treatment for patients with BPH.

This study aimed to evaluate the initial safety and effica-cy of HOLEP in managing BPH in a single tertiary centre.

Materials and methods

Study design and setting

This is a retrospective cohort study conducted at a single tertiary hospital between May 2022 and May 2024. This study aimed to evaluate the safety of HoLEP in patients with enlarged prostate and LUTS, focusing on complica-tions as defined by the Clavien-Dindo classification with-in 30 days post-operatively (6). The study also aimed to evaluate the functional outcomes of HoLEP. An initial review was conducted 1 week post-operatively at the time of catheter removal. Caldicott approval for the study was obtained in line of local trust information governance guidance.

Patient selection

The study included all patients who underwent HoLEP during the specified period. Inclusion criteria were male

Sailantra Sivathasan, Lit Kiat Tan, Brayan Samuel, et al.

patients who were experiencing LUTS and diagnosed with BPH and underwent HoLEP.

Exclusion criteria included patients who had incomplete medical records, and those who underwent other surgical interventions for BPH.

Data collection

Patient data was collected from electronic medical records and included: demographic information, preop-erative clinical characteristics, surgical details, and post-operative outcomes.

The data collected included:

• Demographics: Age and BMI
• Clinical Information: Indication for surgery, prostate size (by trans-abdominal ultrasound or MRI), pre-op catheterisation status, and uroflowmetry
• IPSS - eight-item questionnaire which includes ques-tions on seven symptoms and one Quality of Life ques-tion. The scores are then categorised into Mild (1-7points), Moderate (8-19 points), and Severe (20-35) (Barry, al. 1992)
• Surgical Details: Date of operation, size of enucleation, type of morcellator used, and whether a trainee was scrubbed in.
• Postoperative Outcomes: Duration of catheterization, hospital stay, post-operative uroflowmetry, and post-operative complication.
• Post-operative outcomes were recorded for up to 30

Data analysis

Statistical analyses were performed using SPSSv 25 for Mac (IBM Corp., Armonk, NY, USA). Categorical variables were compared using the Chi-square test, while continu-ous variables were analysed using the independent t-test. Pearson’s correlation coefficient was calculated to assess potential correlations between variables. A p-value of <

0.05 was considered statistically significant.

Results

A total of 108 patients with an enlarged prostate and lower urinary tract symptoms had undergone HoLEP suc-cessfully between May 2022 and May 2024. Four patients were excluded due to incomplete or missing documents. Patient’s characteristics and perioperative data are sum-marized in Table 1.

The data from the Table 2 demonstrates significant improvements in urinary function following Holmium LASER Enucleation of the Prostate (HoLEP). Most notably, the mean Qmax improved by 109%, rising from 11.34

ml/sec to 23.7 ml/sec postoperatively. There is also an

improvement in patient’s mean post void residual volume with a difference of 75.8%, improving from 187.9 ml to

45.6 ml.

Using the Clavien-Dindo classification system, our patient cohort showed that, 13 patients experienced haematuria, of which 6 were admitted for a 3-way catheter for clot retention (CD1) and 1 required a blood transfusion had developed complications (CD 2). Three patients were cat-egorised with CD3 complications (refractory haematuria) requiring clot evacuation under anaesthetic. Seven patients

Table 1.

Baseline patients characteristics and perioperative data.

 

Patients (n = 104)
Parameter	Mean ± SD
Age (years)	73.4 ± 8.6
Preoperative PSA (µg/l)	6.2 ± 6.1
Preoperative QMax (ml/sec)	11.3 ± 15.7
BMI	28.4 ± 4.4
Prostate volume (cm3)	109.3 ± 47.2
Catheter duration (days)	11.4 ± 10.5
Hospital Stay Duration (days)	2.19 ± 1.7
IPSS	21.9 ± 8.5
Enucleation time (min)	46.7 ± 24.1
Morcellation Time (min)	21.9 ± 30.3
Size of enucleation (ml)	66.7 ± 46.6
PSA: prostate-specific antigen; Qmax: maximum flow rate; BMI: Body mass index; IPSS: international prostate symptom score.

 

 Table 2.

Functional parameter pre- and postoperative.

 

Parameter	Preoperative	Postoperative	Percentage change (%)
PVR volume (ml)	187.9 ± 198.2	45.4 ± 43.0	-75.8
Void Volume (ml)	122.6 ± 70.6	187.5 ± 88.6	+52.9
Qmax (ml/sec)	11.34 ± 15.7	23.7 ± 17.6	+109.0
Qmax: maximum flow rate; PVR, post void residual.

 

Table 3.

Correlation of baseline characteristics and complications.

 

Parameter	Complication	No complication	p value
Patients n (%)	21 (19.2)	83 (80.8)	-
Age ≤ 80 n (%)	13 (14.8)	71 (85.2)	0.0141
Age > 80 n (%)	8 (40.0)	12 (60.0)
Anticoagulated n (%)	7 (38.9)	11 (61.1)	0.0666
Not Anticoagulated n (%)	14 (14.6)	72 (85.4)
BMI ≥ 25 n (%)	18 (19.8)	69 (80.2)	0.775
BMI < 25 n (%)	3 (17.6)	14 (82.4)
Mean Enucleation Time (min)	42.8	47.7	0.4112
Mean Morcellation Time (min)	15.9	23.4	0.3261
Prostate volume (ml)	120.7	105.76	0.2697
BMI: Body mass index.

 

 experienced a post operative infection and were treated with antibiotics (CD 2) (6). No patients had a CD4 or CD5 complication. Comparisons between baseline characteris-tics and complications can be seen in Table 3.

The study identified advanced age as a significant predic-tor of complications, this was evident in the age group ≤ 80yrs old, where the incidence of complications was 13 (14.8%) compared to the 8 patients (40%), > 80 yrs that had post operative complications.

Holmium laser enucleation of the prostate

 

Table 4.

Correlation of preoperative prostate volume and incidence of complications.

 

Pre-op prostate volume (ml)	Number (n)	Complications (%)	p value
< 100 ml	44	5 (11%)	1.41 × 10 -7
100-150 ml	21	6 (29%)	0.078
> 150 ml	15	4 (27%)	0.118

 

We also recorded the incidence of complications in patients who were on anticoagulation. Clopidogrel was withheld for 5 days whilst direct oral anticoagulants (DOACs) were withheld for 2 days prior to surgery. 7/18 (38.9%) experienced complications whilst, 13/89 (14.6%) of patients not on prior anticoagulation presented with complications; p value = 0.0666.

Prostates > 100 ml had a relatively consistent complica-tion rate: Prostates measuring 100-150 ml had a compli-cation rate of 6/21 (29%) whilst prostates > 150 ml had a complication rate of 4/15 (27%).

For this specific parameter, 24 patients were excluded from the comparison due to incomplete data regarding pre-operative prostate volume (ml).

Postoperative follow-up highlighted 32 patients (30.1%) that reported experiencing transient urinary incontinence (TUI); however, all patients were successfully managed conservatively with pelvic floor exercise referrals and incontinence resolved. The follow-ups also highlighted 2 (1.9%) patients that were experiencing erectile dysfunc-tion.

 

Discussion

This audit provides an insight into the initial safety and efficacy of HoLEP in the immediate post operative period. By evaluating patient outcomes, the study supports the growing evidence of HoLEP’ s viability as a first-line sur-gical intervention for BPH, particularly in patients with larger prostates. The pre and post operative functional parameters reflect substantial improvements in urinary function. However, the study also highlights an elevated risk of postoperative complications among patients above the age of 80, raising important considerations for patient selection, counselling and perioperative management.

The postoperative improvements in uroflowmetry param-eters demonstrated HoLEP’s early efficacy. The mean increase in Qmax by 109%, from 11.34 ml/sec to 23.7

ml/sec, shows significant improvement in urine flow on

catheter removal a week following the procedure. Similar outcomes have been reported in a systematic review by Ahyai et al (7). Further improvements would be expected at 3 months and beyond postoperatively (7) which unfor-tunately was beyond the scope of this audit.

This study’s demonstration of significant improvements in both Qmax and PVR are consistent with those of Cornu et al (8) which also demonstrated significant improve-

ments in both domains post-HoLEP. This contributed to their recommendation that enucleation should be offered to patients, especially those with prostates over 100 ml,

(8) aligning with our mean prostate volume of 109.3 ±

47.2 ml.

A notable finding from Elmansy et al (4) is the reduction in mean PVR volume, which dropped by 75.8%, results which align with our own. The study also demonstrated a long-term decrease in PVR following HoLEP; further supporting its ability to relieve bladder outlet obstruction effectively.

The most frequent complication reported was postopera-tive haematuria, affecting 12.0% of patients. Previous studies corroborate this finding, with haematuria report-ed in up to 15% of cases, though the majority resolve with conservative management (9, 10).

Our study has shown no statistical difference in postop-erative outcome in patients who are on anticoagulated versus patients who are not. This conclusion is support-ed by El Taye (11) who found that postoperative out-comes between anticoagulated vs non-anticoagulated patients were not statistically significant. This is due to the use of LASER for enucleation which has been shown to reduce the incidence of bleeding complications (12). This reaffirms HoLEP as a safe option for higher risk cases, though individual risk assessment remains crucial. This study identifies advanced age as a significant predic-tor of complications, a finding supported by Elsaqa M et al (13). Patients over 80 years of age had a complication rate of 40%, significantly higher than the 14.8% seen in patients < 80 yrs (p = 0.0101).

Previous studies have reported similar trends, with older patients exhibiting higher rates of postoperative compli-cations due to comorbidities and diminished physiologi-cal reserve (14, 15). Though this stance on HoLEP has been refuted by Mmeje, C.O., et al. who in 2013 stated that age had no significant effect on post operative out-comes and that patients > 80 yrs had similar complica-tions to younger age groups (16). Despite the increased risk we report, the outcomes of HoLEP in elderly patients remain favourable (17).

Initial, transient urinary incontinence (TUI) was reported by 29.6% of patients in the initial one month post opera-tive review. Incontinence incidence decreases significant-ly over time as sphincter function recovers with conti-nence returning in all patients (3). Early recognition and onward referral to specialized pelvic floor therapy was crucial in achieving this outcome.

Nam Jk et al (18) in 2015 stated that patient age above 65 yrs and total operative time > 65 mins were associated with an increased occurrence of post-operative transient urinary incontinence. This paradigm aligns with our study that highlights the average age of patients as 73 years old and our average operative time being 68 min-utes (46.7 mins for enucleation + 21.9 mins for morcella-tion). Possible assumptions would be a combination of chronic pelvic floor weakness and larger prostates enu-cleated with longer operative times. Long-term studies suggest that the incidence of persistent incontinence fol-lowing HoLEP is low, between 1% and 5% after 12 months (4).

Erectile dysfunction (ED) is a rare but known side effect for patients undergoing prostate surgery. In this study, only 1.85% of patients reported new-onset ED, a result consis-tent with the literature (19). HoLEP has been shown to

 

Sailantra Sivathasan, Lit Kiat Tan, Brayan Samuel, et al.

 

have minimal impact on erectile function compared to other surgical treatments, largely because it spares the neu-rovascular bundles responsible for erectile function (5).

The result from this study is further supported in a meta-analysis by Tan et al (3) which found that sexual function is preserved in the vast majority of HoLEP patients mak-ing it an appealing option for sexually active men who want better long-term functional outcomes. Despite the high rate of premature ejaculation expected, HOLEP remained a desirable and durable therapy for BPH in that cohort.

Limitations

While this study provides valuable data on the early out-comes of HoLEP, we acknowledge that the retrospective design of this study exposes us to risk of selection bias due to incomplete data. Second, the follow-up period was limited to one month post HOLEP, and longer-term func-tional outcomes were not assessed in this cohort. This study design was to demonstrate HoLEP’s favourable

early safety and efficacy. Future prospective studies with longer follow-up periods are necessary to provide more comprehensive data on the durability of functional out-comes and complication rates.

Morcellation weight was not included due to significant tissue loss leading to a lack of consistent and reliable specimen weight obtained (20). Therefore, pre-op imag-ing was utilised.

 

Conclusions

This study affirms the short-term safety and efficacy of HoLEP in treating patients with benign prostatic hyper-trophy, particularly those with larger prostates. The pro-cedure offers significant improvements in urinary func-tion, as evidenced by our early postoperative uroflowme-try data, while maintaining minimal risk of significant complications. However, risk factors, more especially age

> 80 yrs, are associated with a higher likelihood of post-operative complications, necessitating careful patient selection, patient counselling, and peri/postoperative management.

 

References

1. National Institute for Health and Care Excellence (NICE). Lower urinary tract symptoms in men: assessment and management (Internet). London: NICE; 2010 (updated 2015; cited 2025 Feb 28).
2. Djavan B, Chapple C, Milani S, Marberger State of the art on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign pro-static hyperplasia. Urology. 2004; 64:1081-8.
3. Tan A, Liao C, Mo Z, Cao Meta-analysis of holmium laser enu-cleation versus transurethral resection of the prostate for sympto-matic prostatic obstruction. Br J Surg. 2007; 94:1201-8.
4. Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of clinical outcomes and complica-tion rates during 10 years of J Urol. 2011; 186:1972-6.
5. Cornu JN, Ahyai S, Bachmann A, et A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015; 67:1066-1096.
6. Dindo D, Demartines N, Clavien Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240:205-13.
7. Ahyai SA, Gilling P, Kaplan SA, et Meta-analysis of function-al outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010; 58:384-97.
8. Cornu JN, Ahyai S, Bachmann A, de la Rosette J, et al. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Eur Urol. 2015; 67:1066-1096
9. Gilling PJ, Kennett K M, Fraundorfer MR, & Holmium Study Holmium laser enucleation of the prostate (HoLEP) versus transurethral resection of the prostate (TURP) in a prospective ran-domized trial with 2-year follow-up. J Endourol 2012; 26: 343-349.
10. Shah HN, Mahajan AP, Hegde SS, & Mahajan Perioperative

 

Holmium laser enucleation of the prostate

outcomes of holmium laser enucleation of prostate in patients on anticoagulant therapy: A comparative study. J Endourol 2016; 30: 850-855.

11. El Tayeb MM, Jacob JM, Bhojani N, et al. Holmium Laser Enucleation of the Prostate in Patients Requiring Anticoagulation. J 2016; 30:805-9.
12. Naspro R, Suardi N, Salonia A, et Holmium laser enucleation of the prostate versus open prostatectomy for prostates > 70 g: 24-month follow-up. Eur Urol. 2006; 50:563-8.
13. Elsaqa M, Zhang Y, El M. MP51-07 Impact of Age and frailty on surgical outcomes of Holmium laser enucleation of prostate (HoLEP) in nonagenarians and octagenarians patients. J Urol. 2023; 209(Suppl 4):e695.
14. Placer J, Gelabert-Mas A, Vallmanya F, et Holmium laser enucleation of the prostate: Outcome and complications of self-taught learning curve. World J Urol 2016; 34:555-562.
15. Montorsi F, Naspro R, Salonia A, et Holmium laser enucle-

ation of the prostate for benign prostatic hyperplasia: indications and techniques. Journal of Endourology. 2016; 30:115-121.

16. Mmeje CO, Nunez-Nateras R, Warner JN, Humphreys Age-stratified outcomes of holmium laser enucleation of the prostate. BJU Int. 2013; 112:982-9.
17. Rieken M, Cornu JN, Gilling P, et Risk factors for intraoper-ative complications in patients undergoing prostate enucleation with holmium laser: results from a large international multicentre study. World Journal of Urology. 2014; 32:421-427.
18. Nam JK, Kim HW, Lee DH, et Risk Factors for Transient Urinary Incontinence after Holmium Laser Enucleation of the Prostate. World J Mens Health. 2015; 33:88-94.
19. Roper C, Slade A, Caras R, et Ejaculatory and erectile func-tion outcomes following holmium laser enucleation of the prostate. Prostate. 2024; 84:791-796.
20. Savin Z, Dekalo S, Herzberg H, et al. Improving Prostatic Preoperative Volume Estimation and Planning before Laser Enucleation. J Pers 2022; 12:1761.

 

Correspondence

Mr Sailantra Sivathasan Dr Lit Kiat Tan

Mr Chigozie Onyeze

NHS Tayside Ninewells Hospital

 

Mr Brayan Samuel (Corresponding Author)

brayansamuel2003@gmail.com Ninewells Hospital, University of Dundee

Mr Amit Kalpee

NHS Tayside Ninewells Hospital Ninewells hospital, University of Dundee