EAU-Guidelines-on-Non-Neurogenic-Male-LUTS-2025-2
Guidelines Associates and Office
J.N. Cornu (Chair), M. Gacci, H. Hashim, T.R.W. Herrmann, S. Malde, C. Netsch, C. De Nunzio, M. Rieken, V. Sakalis, M. Tutolo
Guidelines Associates: M. Baboudjian, N. Bhatt, M. Creta, M. Karavitakis, L. Moris
Guidelines Office: N. Schouten
© European Association of Urology 2025
Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS)
EAU Guidelines on
Table of Contents
1. INTRODUCTION
1.1 Aim and objectives
1.2 Panel composition
1.3 Available publications
1.4 Publication history
1.4.1 Publication history
1.4.2 Summary of changes
2. METHODS
2.1 Introduction
2.2 Review
2.3 Patients to whom the guidelines apply
3. EPIDEMIOLOGY, AETIOLOGY, AND PATHOPHYSIOLOGY
4. DIAGNOSTIC EVALUATION
4.1 Medical history
4.2 Symptom score questionnaires
4.2.1 The International Prostate Symptom Score (IPSS)
The IPSS is an eight-item questionnaire. The IPSS assesses the severity of LUTS and their impact on a patient's quality of life. The questionnaire covers seven urinary symptoms: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each symptom is scored on a scale of 0 to 5, with a total score ranging from 0 to 35. Additionally, there is a single question addressing the patient's quality of life (QoL) related to urinary symptoms.
The IPSS score categories: ‘asymptomatic’ (0 points), ‘mildly symptomatic’ (1-7 points), ‘moderately symptomatic’ (8-19 points), and ‘severely symptomatic’ (20-35 points).
4.2.2 The International Consultation on Incontinence Questionnaire for Male LUTS (ICIQ-MLUTS)
The ICIQ-MLUTS was created from the International Continence Society (ICS) Male questionnaire. It is a widely used and validated patient-completed questionnaire including incontinence questions and bother for each symptom. The ICIQ-MLUTS is designed to evaluate lower urinary tract symptoms (LUTS) specifically in men, focusing on the impact of these symptoms on their quality of life. This tool covers various aspects of LUTS, including voiding, storage, and post-micturition symptoms.
4.2.3 Danish Prostate Symptom Score (DAN-PSS)
The DAN-PSS is a symptom score used mainly in Denmark and Finland. The DAN-PSS has twelve questions divided into parts A and B with questions on incontinence and measures the bother of each individual LUTS. It includes questions related to urinary frequency, nocturia, urgency, weak stream, intermittency, incomplete emptying, and incontinence. The score is calculated based on the responses provided, offering a detailed assessment of LUTS.
4.2.4 The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN-SI-10)
The LURN-SI-10 correlates strongly with the IPSS but identifies additional important symptomatology including incontinence and bladder pain in men with LUTS. This questionnaire helps in identifying key symptoms such as urinary frequency, urgency, nocturia, weak stream, intermittency, incomplete emptying, pain or discomfort, and incontinence. By including these additional aspects, the LURN-SI-10 provides a more comprehensive evaluation of LUTS.
4.3 Frequency volume charts and/or bladder diaries
The recording of the volume and time of each void by the patient is referred to as an FVC. Inclusion of additional information such as fluid intake, use of pads, activities during recording, or which grades symptom severity and bladder sensation, is termed a bladder diary.
The ICIQ-Bladder diary (ICIQ-BD) is the only diary that has undergone full validation [43].
4.4 Physical examination and digital-rectal examination
Physical examination particularly focusing on the suprapubic area, the external genitalia, the perineum, and lower limbs should be performed. Urethral discharge, meatal stenosis, phimosis, and penile cancer must be excluded.
4.4.1 Digital-rectal examination and prostate size evaluation
Digital-rectal examination (DRE) is the simplest way to assess prostate volume, but the correlation to prostate volume is poor. During a DRE, the physician can assess the size, shape, and consistency of the prostate gland. This examination is essential for detecting abnormalities such as nodules, areas of hardness, or asymmetry, which may indicate prostate cancer or other prostate conditions.
4.5 Urinalysis
Urinalysis (dipstick or microscopy) must be included in the primary evaluation of any patient presenting with LUTS to identify conditions, such as urinary tract infections (UTI), microhaematuria and diabetes mellitus. The process involves both a visual examination and chemical tests using a dipstick. Microscopic examination, if performed, can identify red blood cells, white blood cells, bacteria, and crystals, providing valuable insights into potential underlying conditions.
4.6 Prostate-specific antigen
4.6.1 Prostate-specific antigen and the prediction of prostatic volume
Pooled analysis of RCTs, of men with LUTS and presumed BPO, showed that prostate-specific antigen (PSA) has a good predictive value for assessing prostate volume, with areas under the curve (AUC) of 0.76-0.78 for various prostate volume thresholds (30 mL, 40 mL, and 50 mL).
4.6.2 Prostate-specific angtigen and the probability of PCa
The role of PSA in the diagnosis of PCa is presented by the EAU Guidelines on Prostate Cancer [60]. The potential benefits and harms of using serum PSA testing to diagnose PCa in men with LUTS should be discussed with the patient. It is important to inform patients about the limitations of PSA testing, including the risk of false positives and false negatives, and the potential for overdiagnosis.
4.6.3 Prostate-specific antigen and the prediction of BPO-related outcomes
Serum PSA is a stronger predictor of prostate growth than prostate volume. Elevated serum PSA levels may indicate a higher risk of disease progression, including increased prostate volume and worsening of LUTS. Monitoring PSA levels over time can provide valuable prognostic information.
4.7 Renal function measurement
Renal function may be assessed by serum creatinine or estimated glomerular filtration rate (eGFR). The eGFR is often calculated using serum creatinine levels along with other factors such as age, sex, and race. Regular monitoring of renal function is particularly important in individuals with chronic conditions such as diabetes, hypertension, or heart failure.
4.8 Post-void residual urine
Post-void residual (PVR) urine can be assessed by transabdominal ultrasound (US), bladder scan or catheterisation.
Since the role of PVR in males with LUTS has given inconclusive data, bladder voiding efficiency (BVE; [voided volume/total bladder capacity] × 100) has been introduced
4.9 Uroflowmetry
Urinary flow rate assessment is a widely used non-invasive urodynamic test. Key parameters are Qmax, voided volume, PVR, and flow pattern. Uroflowmetry parameters should preferably be evaluated with voided volume > 150 mL.
A threshold Qmax of 10 mL/s has a specificity of 70%, a PPV of 70% and a sensitivity of 47% for BOO. The specificity using a threshold Qmax of 15 mL/s was 38%, the PPV 67% and the sensitivity 82% [88].
4.10 Imaging
4.10.1 Upper urinary tract
Men with LUTS are not at increased risk for upper tract malignancy or other abnormalities when compared to the overall population
4.10.2 Prostate
Imaging of the prostate can be performed by transabdominal US, TRUS, computed tomography (CT), and magnetic resonance imaging (MRI).
4.10.2.1 Prostate size and shape
Assessment of prostate size is important for the selection of interventional treatment
4.10.3 Voiding cysto-urethrogram
Voiding cysto-urethrogram (VCUG), on its own, is not recommended in the routine diagnostic work-up of men with LUTS, but it may be useful for the detection of vesico-ureteral reflux, bladder diverticula, or urethral diseases and can be combined with urodynamics in the form of video-urodynamics.
4.11 Urethrocystoscopy
Patients with a history of microscopic or gross haematuria, urethral stricture, or bladder cancer, who present with LUTS, should undergo urethrocystoscopy during diagnostic evaluation. This procedure can reveal abnormalities such as inflammation, strictures, or tumors in the urethra and bladder. It is particularly valuable in identifying the cause of bleeding or obstruction in the urinary tract. The findings from urethrocystoscopy guide further diagnostic and therapeutic interventions.
4.12 Urodynamics
In male LUTS, the most widespread invasive urodynamic techniques employed are filling cystometry and pressure flow studies (PFS).
The major goal of urodynamics (UDS) is to explore the functional mechanisms of LUTS, to identify risk factors for adverse outcomes and to provide information for shared decision-making.
4.12.1 Diagnosing bladder outlet obstruction
Pressure flow studies are used to diagnose and define the severity of BOO, which is characterised by increased detrusor pressure and decreased urinary flow rate during voiding.
Bladder outlet obstruction is calculated according to the equation (BOO > 40 = obstructed; BOO 20-40 = equivocal; and BOO < 20 = unobstructed)
To assess the contractility of the bladder, is calculated according to the equation (BCI > 150 = strong contractility, 100-150 = normal contractility, and < 100 weak contractility)
4.12.2 Videourodynamics
Videourodynamics provides additional anatomical and functional information and may be recommended if the clinician considers this is needed to understand the pathophysiological mechanism of an individual patient’s LUTS. This technique combines traditional urodynamic testing, such as cystometry and pressure-flow studies, with real-time imaging using fluoroscopy. This allows for a comprehensive assessment of bladder function and anatomical structures during the filling and voiding phases.
4.13 Non-invasive tests in diagnosing bladder outlet obstruction in men with LUTS
4.13.1 Prostatic configuration/intravesical prostatic protrusion
Prostatic configuration can be evaluated with TRUS, using the concept of the presumed circle area ratio (PCAR).
Ultrasound measurement of intravesical prostatic protrusion (IPP) assesses the distance between the tip of the prostate median lobe and bladder neck in the midsagittal plane, using a suprapubically positioned US scanner, with a bladder volume of 150-250 mL; grade I protrusion is 0-4.9 mm, grade II is 5-10 mm and grade III is > 10 mm.
4.13.2 Bladder/detrusor wall thickness and ultrasound-estimated bladder weight
For bladder wall thickness (BWT) assessment, the distance between the mucosa and the adventitia is measured.
For detrusor wall thickness (DWT) assessment, the only measurement needed is the detrusor sandwiched between the mucosa and adventitia
4.13.3 Non-invasive pressure-flow testing
The penile cuff test (PCT), in which flow is interrupted to estimate isovolumetric bladder pressure, shows promising data, with good test repeatability [131] and interobserver agreement [132].
4.13.4 The diagnostic performance of non-invasive tests in diagnosing bladder outlet obstruction in men with LUTS compared with pressure-flow studies
A SR including 42 studies investigated the diagnostic performance of non-invasive tests in diagnosing BOO in men with LUTS compared with UDS/PFS [140].
4.14 Novel assessment
4.14.1 Visual prostate symptom score
A novel visual prostate symptom score (VPSS) has been prospectively tested vs. the IPPS and correlated positively with the IPSS score.
4.14.2 Micro-RNA
The use of miR-221 has been shown to have the potential to be used as a biomarker and novel target in the early diagnosis and therapy of BPH
5. DISEASE MANAGEMENT
5.1 Conservative treatment
5.1.1 Watchful waiting
Watchful waiting is a viable option for many men with non-bothersome LUTS as few will progress to AUR and complications (e.g. renal insufficiency or stones). Regular follow-up appointments are essential to monitor symptom progression and detect any new developments. During these appointments, patients may undergo repeat evaluations, including symptom questionnaires, uroflowmetry, and PVR measurements, to assess the stability or progression of their condition.
5.1.2 Behavioural and dietary modifications
reduction of fluid intake at specific times aimed at reducing urinary frequency when most inconvenient (e.g., at night or when going out in public);
avoidance/moderation of intake of caffeine or alcohol, which may have a diuretic and irritant effect, thereby increasing fluid output and enhancing frequency, urgency and nocturia;
use of relaxed and double-voiding techniques;
urethral milking to prevent post-micturition dribble;
distraction techniques such as penile squeeze, breathing exercises, perineal pressure, and mental tricks to take the mind off the bladder and toilet, to help control OAB symptoms;
bladder retraining that encourages men to hold on when they have urgency to increase their bladder capacity and the time between voids;
reviewing the medication and optimising the time of administration or substituting drugs for others that have fewer urinary effects (these recommendations apply especially to diuretics);
providing necessary assistance when there is impairment of dexterity, mobility, or mental state;
treatment of constipation.
5.1.3 Practical considerations
The components of self-care management have not been individually studied. The above components of lifestyle advice have been derived from formal consensus methodology [154]. Patients should be educated about the rationale behind each recommendation and encouraged to actively participate in their care. This can involve keeping a bladder diary to track fluid intake, voiding patterns, and symptom severity, as well as setting realistic goals for behavioural changes.
5.2 Pharmacological treatment
5.2.1 α1-Adrenoceptor antagonists (α1-blockers)
Mechanism of action: α1-blockers aim to inhibit the effect of endogenously released noradrenaline on smooth muscle cells in the prostate and thereby reduce prostate tone and BOO [155]. However, α1-blockers have little effect on urodynamically determined bladder outlet resistance [156], and treatment-associated improvement of LUTS correlates poorly with obstruction [157].
Efficacy: Indirect comparisons and limited direct comparisons between α1-blockers demonstrate that all α1-blockers have a similar efficacy in appropriate doses [158]. The choice of α1-blocker may depend on individual patient factors such as co-existing medical conditions, potential drug interactions, and cost considerations. It is important to consider these factors to optimize treatment outcomes.
Tolerability and safety: Tissue distribution, subtype selectivity, and pharmacokinetic profiles of certain formulations may contribute to the tolerability profile of specific drugs. The most frequent adverse events of α1-blockers are asthenia, dizziness and (orthostatic) hypotension. Patients should be informed about these potential side effects and advised to take precautions to minimize their impact, such as rising slowly from a seated or lying position.
5.2.2 5α-reductase inhibitors
Mechanism of action: Androgen effects on the prostate are mediated by dihydrotestosterone (DHT), which is converted from testosterone by the enzyme 5α-reductase [178], which has two isoforms:
5α-reductase type 1: predominant expression and activity in the skin and liver.
5α-reductase type 2: predominant expression and activity in the prostate.
Two 5-ARIs are available for clinical use: dutasteride and finasteride. Finasteride inhibits only 5α-reductase type 2, whereas dutasteride inhibits both 5α-reductase types (dual 5-ARI).
Efficacy: Clinical effects relative to placebo are seen after treatment of at least six months. After two to four years of treatment 5-ARIs improve IPSS by approximately 15-30%, decrease prostate volume by 18-28%, and increase Qmax by 1.5-2.0 mL/s in patients with LUTS due to prostate enlargement. These improvements translate to enhanced urinary flow, reduced urinary frequency and urgency, and better overall quality of life for patients with LUTS.
Tolerability and safety: The most common adverse events are reduced libido, erectile dysfunction (ED) and less frequently, ejaculation disorders such as retrograde ejaculation, ejaculation failure, or decreased semen volume. It is important to discuss these potential side effects with patients before initiating treatment, and to monitor them during treatment to ensure they are manageable.
5.2.3 Muscarinic receptor antagonists
Mechanism of action: The detrusor is innervated by parasympathetic nerves whose main neurotransmitter is acetylcholine, which stimulates muscarinic receptors (M-cholinoreceptors) on the smooth muscle cells.
The following muscarinic receptor antagonists are licensed for treating OAB/storage symptoms: darifenacin hydrobromide (darifenacin); fesoterodine fumarate (fesoterodine); oxybutynin hydrochloride (oxybutynin); propiverine hydrochloride (propiverine); solifenacin succinate (solifenacin); tolterodine tartrate (tolterodine); and trospium chloride.
Efficacy: Antimuscarinics were mainly tested in females in the past, as it was believed that LUTS in men were caused by the prostate, so should be treated with prostate-specific drugs. It is now recognized that overactive bladder (OAB) symptoms can also contribute to LUTS in men, and antimuscarinics can be effective in managing these symptoms. Clinical trials have demonstrated improvements in urinary frequency, urgency, and urge incontinence with antimuscarinic use in men with OAB.
Tolerability and safety: Antimuscarinic drug trials generally show approximately 3-10% withdrawals, which is similar to placebo. Drug-related adverse events include dry mouth (up to 16%), constipation (up to 4%), micturition difficulties (up to 2%), nasopharyngitis (up to 3%), and dizziness (up to 5%). Many of these side effects are dose-dependent, and starting with a lower dose can help minimize their impact. Additionally, patients should be advised to maintain adequate hydration and consider using over-the-counter remedies for dry mouth and constipation.
5.2.4 Beta-3 agonist
Mechanism of action: Beta-3 adrenoceptors are the predominant beta receptors expressed in the smooth muscle cells of the detrusor and their stimulation is thought to induce detrusor relaxation.
Efficacy: Mirabegron 50 mg is the first clinically available beta-3 agonist with approval for use in adults with OAB. Clinical studies have shown that mirabegron can reduce urinary frequency, urgency, and urge incontinence episodes in patients with OAB. It is often used as an alternative to antimuscarinics, particularly in patients who experience intolerable side effects with antimuscarinic medications.
Tolerability and safety: The most common treatment-related adverse events in the mirabegron groups were hypertension, UTI, headache and nasopharyngitis. While generally well-tolerated, mirabegron can cause an increase in blood pressure in some patients. Regular monitoring of blood pressure is recommended, particularly in individuals with pre-existing hypertension.
5.2.5 Phosphodiesterase 5 inhibitors
Mechanism of action: Phosphodiesterase 5 inhibitors (PDE5Is) increase intracellular cyclic guanosine monophosphate, thus reducing smooth muscle tone of the detrusor, prostate, and urethra. By inhibiting PDE5, these drugs enhance the effects of nitric oxide, promoting smooth muscle relaxation and vasodilation in the lower urinary tract.
Efficacy: Randomised controlled trials have demonstrated that PDE5Is reduce IPSS, storage and voiding LUTS, and improve QoL. However, Qmax did not significantly differ from placebo in most trials. These improvements are likely due to the combined effects of PDE5Is on the bladder, prostate, and urethra, leading to improved urinary symptoms and quality of life.
Tolerability and safety: Reported adverse effects in RCTs comparing the effect of all PDE5Is vs. placebo in men with LUTS include flushing, gastroesophageal reflux, headache, dyspepsia, back pain and nasal congestion. It is important to discuss these potential side effects with patients before initiating treatment. PDE5Is are contraindicated in patients taking nitrates due to the risk of severe hypotension.
5.2.6 Plant extracts – phytotherapy
Potential mechanism of action: Herbal drug preparations are made of roots, seeds, pollen, bark, or fruits. There are single plant preparations (mono-preparations) and preparations combining two or more plants in one pill (combination preparations)
Efficacy: The extracts of the same plant produced by different companies do not necessarily have the same biological or clinical effects; therefore, the effects of one brand cannot be extrapolated to others. Clinical trials evaluating the efficacy of phytotherapy for LUTS have shown variable results. Some studies suggest modest improvements in IPSS and Qmax with certain plant extracts, while others show no significant benefits compared to placebo. The heterogeneity in study designs, patient populations, and plant extracts used makes it challenging to draw definitive conclusions about the efficacy of phytotherapy for LUTS.
5.2.7 Combination therapies
5.2.7.1 α1-blockers + 5α-reductase inhibitors
Mechanism of action: Combination therapy consists of an α1-blocker (Section 5.2.1) together with a 5-ARI (Section 5.2.2). The α1-blocker exhibits clinical effects within hours or days, whereas the 5-ARI needs several months to develop full clinical efficacy.
Efficacy: Several studies have investigated the efficacy of combination therapy against an α1-blocker, 5-ARI, or placebo alone. Clinical trials have demonstrated that combination therapy is more effective than either medication alone in improving LUTS, reducing prostate volume, and increasing Qmax. Combination therapy is typically reserved for men with moderate-to-severe LUTS and enlarged prostates.
Tolerability and safety: Adverse events for both drug classes have been reported with combination treatment. The most common side effects include sexual dysfunction (reduced libido, erectile dysfunction, ejaculation disorders) and dizziness. Patients should be carefully monitored for these adverse events and provided with appropriate management strategies if they occur.
5.2.7.2 α1-blockers + muscarinic receptor antagonists
Mechanism of action: Combination treatment consists of an α1-blocker together with an antimuscarinic aiming to antagonise both α1-adrenoceptors and muscarinic receptors. The possible combinations have not all been tested in clinical trials to date.
Efficacy: Several RCTs and prospective studies investigated combination therapy, lasting four to twelve weeks, either as an initial treatment in men with OAB and presumed BPO or as a sequential treatment for storage symptoms persisting while on an α1-blocker. Clinical trials have demonstrated that this combination can improve both voiding and storage symptoms. However, this combination should be used with caution, as it can increase the risk of urinary retention, particularly in men with large prostates and high post-void residual volumes.
Tolerability and safety: Adverse events of both drug classes are seen with combined treatment using α1-blockers and antimuscarinics. The most common side-effect is dry mouth. Patients should be monitored for anticholinergic side effects such as constipation, blurred vision, and cognitive impairment.
5.2.7.3 α1-blockers + Beta-3 agonist
Mechanism of action: Combination therapy consists of an α1-blocker (Section 5.2.1) together with a beta-3-agonist (Section 5.2.4) as an add-on therapy in males receiving α1-blockers with persisting OAB symptoms.
Efficacy: The MATCH study explored the effect of the addition of mirabegron 50 mg to tamsulosin 0.2 mg compared to tamsulosin plus placebo in 544 patients. Results from the MATCH study showed that the addition of mirabegron to tamsulosin significantly improved OAB symptoms compared to tamsulosin alone. This combination may be beneficial for men with persistent storage symptoms despite α1-blocker therapy.
Tolerability and safety: In the MATCH study main adverse events were in line with previous trials, and cardiovascular events were uncommon in the studied populations. However, blood pressure should be monitored regularly, as both α1-blockers and beta-3 agonists can affect cardiovascular parameters.
5.2.7.4 α1-blockers + Phosphodiesterase 5 inhibitors
Mechanism of action: Combination treatment consists of an α1-blocker together with a phosphodiesterase 5 inhibitor (Section 5.2.5) with the intent to achieve better improvements in LUTS.
Efficacy: A meta-analysis of five RCTs (two studies with tadalafil 20 mg daily, two with sildenafil 25 mg, and one with vardenafil 20 mg), showed that combination therapy significantly improved IPSS score (-1.8), IIEF score (+3.6) and Qmax (+1.5 mL/s) compared with α-blockers alone [255]. This combination is particularly useful in men who experience both LUTS and erectile dysfunction, as PDE5Is can address both conditions simultaneously.
Tolerability and safety: No serious AEs have been reported in the association of PDE5Is and α-blockers.
5.3 Surgical treatment of benign prostatic obstruction
Based on its ubiquitous availability, as well as its efficacy, monopolar TURP (M-TURP) has long been considered as the reference technique for the surgical management of LUTS/BPO. Monopolar TURP involves the use of a high-frequency electrical current to resect prostatic tissue. Despite its effectiveness, M-TURP is associated with certain risks, including bleeding, transurethral resection syndrome (TURS), and urinary incontinence.
The chapter on surgical management has been restructured. It is now divided into the following five sections:
1. Resection
2. Enucleation
3. Vaporisation
4. Alternative ablative techniques
5. Non-ablative techniques.
5.3.1 Resection of the prostate
5.3.1.1 Monopolar and bipolar transurethral resection of the prostate
Mechanism of action: Transurethral resection of the prostate is either performed in a M-TURP or bipolar TURP (B-TURP) fashion. Transurethral resection of the prostate removes tissue from the transition zone of the gland in various degrees resulting in a volume and PSA reduction of 25 -58%. Bipolar TURP utilizes a different electrical circuit that allows for resection in a saline environment, reducing the risk of TURS.
Efficacy: In a meta-analysis of twenty RCTs with a maximum follow-up of five years, M-TURP resulted in a substantial mean Qmax improvement (+162%), a significant reduction in IPSS (-70%), QoL score (-69%), and PVR (-77%) [320]. These improvements are well-documented and make TURP a highly effective surgical option for men with BPO.
Tolerability and safety: Peri-operative mortality and morbidity of M-TURP have decreased over time, but morbidity remains considerable (0.1% and 11.1%, respectively) [342]. Potential complications include bleeding, infection, urinary incontinence, erectile dysfunction, and retrograde ejaculation. Patients should be thoroughly evaluated and counselled about these risks before undergoing TURP.
5.3.1.2 Holmium laser resection of the prostate
With the advent of holmium laser enucleation of the prostate (section 5.3.2.3) and the fact that no relevant publications on holmium laser resection of the prostate (HoLRP) have been published since 2004, HoLRP of the prostate does not play a role in contemporary treatment algorithms
5.3.1.3 Thulium:yttrium-aluminium-garnet laser vaporesection of the prostate
Mechanism of action: In the Thulium:yttrium-aluminium-garnet laser (Tm:YAG), a wavelength between 1,940 and 2,013 nm is emitted in continuous wave mode. The laser is primarily used in front-fire applications
Efficacy: Several meta-analyses with pooled data from both RCTs, and non-RCTs have evaluated ThuVARP vs. M-TURP [352-354], and B-TURP [355-357]. The largest meta-analyses included nine RCTs and seven non-RCTs and reported no clinically relevant differences in efficacy (IPSS, QoL score and Qmax) between ThuVARP and M-TURP or B-TURP at twelve months
Tolerability and safety: In a number of meta-analyses longer operation times, shorter catheterisation/ hospitalisation times and less blood loss without significant differences in transfusion rates or in any other short-term complication rates have been reported for ThuVARP compared to TURP
5.3.1.4 Transurethral incision of the prostate
Mechanism of action: Transurethral incision of the prostate (TUIP) involves incising the bladder outlet without relevant tissue removal. TUIP is primarily used for men with small prostates (typically < 30 mL) and minimal median lobe enlargement.
Efficacy: An RCT comparing conventional TUIP vs. TUIP using holmium laser in prostates ≤ 30 mL with a follow-up of twelve months, found both procedures to be equally effective in relieving BOO with similarly low re-operation rates
Tolerability and safety: An RCT comparing conventional TUIP vs. TUIP using holmium laser reported both procedures to be safe with low complication rates; however, the operation time and retrograde ejaculation rate was significantly lower in the conventional TUIP arm
5.3.2 Enucleation of the prostate
5.3.2.1 Open prostatectomy
Mechanism of action: Open prostatectomy (OP) is the oldest surgical treatment for moderate-to-severe LUTS secondary to BPO. It involves making an incision in the abdomen to access and remove the enlarged prostate tissue. This procedure is typically reserved for men with very large prostates (e.g., > 80-100 mL) or those with co-existing bladder diverticula or stones.
Efficacy: Open prostatectomy reduces LUTS by 63-86% (12.5-23.3 IPSS points), improves QoL score by 60-87%, increases mean Qmax by 375% (+16.5-20.2 mL/s), and reduces PVR by 86-98%.
Tolerability and safety: Two meta-analyses evaluated the overall safety of OP performed via a transvesical approach vs. B-TUEP and HoLEP [373, 374]. Operation time did not differ significantly between OP and B-TUEP but was significantly shorter for OP compared to HoLEP. Open prostatectomy is associated with a higher risk of complications compared to minimally invasive techniques. These complications include bleeding, infection, blood transfusion, urinary incontinence, erectile dysfunction, and incisional hernia.
5.3.2.2 Bipolar transurethral enucleation of the prostate
Mechanism of action: Following the principles of bipolar technology (section 5.3.1.1), the obstructive adenoma is enucleated endoscopically by the transurethral approach. Currently, two technologies exist, namely plasmakinetic (PK) enucleation of the prostate (PKEP) and bipolar plasma enucleation of the prostate (BPEP)
Efficacy: Two meta-analyses, reported similar efficacy at twelve months in terms of IPSS, QoL score and Qmax for B-TUEP (PKEP or BPEP) vs. B-TURP
Tolerability and safety: Two meta-analyses evaluating B-TUEP vs. B-TURP reported similar operation, catheterisation and hospitalisation times; lower acute urine retention rates; significantly reduced haemoglobin