[Minimally invasive treatment of benign prostatic hyperplasia : The German S2e guideline 2023-part 4]. / Minimalinvasive Therapien des benignen Prostatasyndroms : Die deutsche S2e-Leitlinie 2023 ­ Teil 4/4.

BACKGROUND: Lower urinary tract symptoms suggestive for benign prostatic obstruction (LUTS/BPO) are one of the most frequent diseases in men and can have a significant impact on quality of life. Instrumental therapies are common, and many patients seek minimally invasive treatment options. OBJECTIVE: Presentation and evidence-based evaluation of the minimally invasive therapy for benign prostatic syndrome. MATERIALS AND METHODS: Summary and overview of chapters 11-13 on minimally invasive therapies for LUTS/BPO of the current long version of the German S2e guideline. RESULTS: In case of absolute indication for surgery or after unsatisfactory or undesired medical therapy, minimally invasive treatments such as UroLift® (Neotract Inc., Pleasanton, CA, USA), Rezá¿¡m™ (Boston Scientific, Malborough, MA, USA), iTIND™ (Olympus America Inc., Westborough, MA, USA), and prostatic artery embolization (PAE) can be considered. These indirect/delayed ablative therapies offer lower morbidity and the possibility of performing them under local anesthesia, but they are inferior to direct ablative/resective techniques in terms of effectiveness and sustainability. CONCLUSIONS: The updated German S2e guideline summarizes evidence-based recommendations for new minimally invasive therapies for LUTS/BPO, which present alternative treatment options for selected patients.

[Conservative and pharmacological treatment of benign prostatic hyperplasia : The German S2e-guideline 2023-part2]. / Konservative und medikamentöse Therapie des benignen Prostatasyndroms : Die deutsche S2e-Leitlinie 2023 ­ Teil 2.

BACKGROUND: Lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH, in German guidelines: benign prostatic syndrome [BPS]) is considered the most common disease of the lower urinary tract in men and can have a tremendous impact on the quality-of-life of affected patients. Conservative and pharmacological therapy of this disease are of great importance, both in improving LUTS and reducing progression-related complications. OBJECTIVES: Presentation of the conservative and pharmacological treatment options according to the current German S2e guideline on BPS. MATERIALS AND METHODS: Summary and overview of chapters 9 and 10 of the current German S2e guideline on BPS. RESULTS: In addition to a controlled watchful waiting for BPS patients without an absolute indication for prostate surgery, a variety of phytopharmacological formulations and synthetic drugs according to the symptomatology and clinical progress are available. Phytotherapy should, due to inconsistent study data, only be considered for mild to moderate symptoms. Synthetic drugs include alpha-blockers, 5α-reductase inhibitors, phosphodiesterase inhibitors, antimuscarinics and, more recently, the ß3-agonist mirabegron in the current guideline. In addition, various combination therapies are listed and evaluated according to their indications, effects and side effects. CONCLUSIONS: The current German S2e guideline on the diagnosis and treatment of BPS provides an evidence-based foundation for finding the best possible and most effective medication.

Transurethral resection of the prostate in 85+ patients: a retrospective, multicentre study.

PURPOSE: To determine the safety and efficacy of transurethral resection of the prostate (TUR-P) in patients 85 years or older. METHODS: In this retrospective, multicentre study, patients equal or older than 85 years at the time of surgery (2015-2020) were included. Several pre-, peri- and postoperative parameters were collected. The main outcome criterion was spontaneous voiding with a post-void residual (PVR) volume < 100 ml at dismission and at 12 months after surgery. RESULTS: One hundred sixty-eight patients (median age: 87 years, interquartile range [IQR]: 86-89) were recruited. The patients took on average 5.2 permanent medications (3-8), 107 (64%) were anticoagulated preoperatively and neurological co-morbidities were present in 29 (17%). The indication for surgery was recurrent urinary retention in 66.3% (n = 110) with a mean retention volume of 849 ml. The mean PVR volume of the remaining 35% was 146 ml. Surgery was successfully completed in all patients. A perioperative surgical revision had to be performed in 3% and 13 patients (7.7%) required blood transfusion. After catheter removal, 85% of patients were able to void spontaneously with a PVR < 100 ml, and 14.3% were dismissed with a catheter. Twelve months data were available for 93 patients (55%). Of this cohort, 78 (83.9%) were able to void spontaneously with a PVR < 100 ml, 12 (12.9%) were on permanent catheterization. One patient (0.6%) died perioperatively. The only significant factor associated with an unsuccessful outcome was the number of permanent medications (6.8 vs. 5.0, p = 0.005). CONCLUSION: This retrospective multicentre study documents the safety and efficacy of TURP (monopolar and bipolar) in the old-old cohort.

The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia.

OBJECTIVES: To provide an update on novel minimally invasive lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) treatments in a non-systematic review. To define potential target populations for the various new minimally invasive treatments. METHODS: Recent literature, meta-analyses and guideline recommendations for aquablation (AquaBeam® ; PROCEPT BioRobotics, Redwood City, CA, USA), water vapour thermal therapy (Rezum® ; Boston Scientific, Natick, MA, USA), prostate artery embolisation (PAE), prostatic urethral lift (UroLift® ; NeoTract-Teleflex, Pleasanton, CA, USA) and the temporary implantable nitinol device [i-TIND® (nitinol butterfly-like stent ); Medi-Tate Ltd., Or-Akiva, Israel] were reviewed. RESULTS: Procedures that can be performed on an outpatient basis (Rezum, PAE, UroLift and i-TIND) are not an alternative for the standard patient requiring BPH surgery. Their effect on urinary flow, post-void residual urine volume or bladder outlet obstruction is less pronounced than that of transurethral resection of the prostate (TURP). Yet, these options appear to be valuable for those patients unfit for surgery, men who want to avoid medical therapy in general, or those who want to avoid sexual side-effects associated with medical therapy or standard BPH surgery (e.g. TURP). Aquablation is the first successfully operationalised robotic resection system, especially for patients with prostates >50 g. Nevertheless, long-term data are necessary for all novel, minimally invasive treatments. CONCLUSIONS: Better designed clinical trials, a clearer definition of target populations and a more realistic marketing allow a better characterisation of novel minimally invasive therapies for LUTS/BPH. It is hoped that some of these novel devices will stand the test of time, in contrast to the vast majority of their predecessors.

Can a Simple Geriatric Assessment Predict the Outcome of TURP?

PURPOSE: To determine the impact of a simple preoperative geriatric assessment on the outcome in older patients with recurrent urinary retention who underwent desobstructive surgery. PATIENTS AND METHODS: Patients aged 75 years or older with recurrent urinary retention referred for TURP entered this prospective, multicentre study. Several demographic, intra- and postoperative parameters were assessed. Preoperative geriatric assessment was performed by the 7-item Canadian Study of Health and Ageing (CSHA) frailty scale (1: very fit, 7: severely frail; completion takes less than a minute). The main outcome parameters were successful voiding rates at discharge and 3 months postoperatively. RESULTS: A total of 54 patients were recruited; 42 (77.8%) patients had a CSHA index of 1-3 and were considered as "fit", the remaining 12 (22.2%) formed the "frail" group (CSHA index 4-7). Age was identical in both cohorts (79.5 ± 3.7 vs. 79.7 ± 3.3 years); differences were demonstrable for the American Society of Anesthesiologists (ASA) score (p = 0.001), the number of daily medications (>4: 32 vs. 75%, p = 0.02), falls within the past 6 months (12 vs. 33%), and the necessity of home/nursing care (5 vs. 42%, p = 0.004). Intra- and perioperative complications, duration of postoperative catheterization, and length of hospitalization were identical in both cohorts. The success rate at discharge was 80.6% in fit and 75.0% in frail patients; the respective values at 3 months were 95.2 and 83.3%. CONCLUSIONS: A simple 1-min geriatric assessment tool can predict - to a certain extent - the outcome of desobstructive surgery in older patients with recurrent urinary retention. Fit patients achieve an excellent outcome while frail patients might benefit from a more in-depth urodynamic/geriatric evaluation.

Phytotherapy Adds to the Therapeutic Armamentarium for the Treatment of Mild-To-Moderate Lower Urinary Tract Symptoms in Men.

BACKGROUND: Practice guidelines hardly recommend herbal extracts for male lower urinary tract symptoms (LUTS). However, many patients are unsatisfied with first-line synthetic drugs and often prefer herbal medicines because of good tolerability. To improve the decision-making process, which should consider the patients' expectations, it is crucial to reflect on the role of phytotherapy in the treatment of LUTS. We (panel experts) reflected on current guideline recommendations and real practice across various European countries and debated the potential role of plant extracts with a focus on pumpkin seed soft extract investigated over 12 months in two randomised placebo-controlled trials. SUMMARY: Most guidelines give no clear recommendations on phytotherapy due to the heterogeneity of clinically investigated extracts. Nevertheless, plant extracts are prescribed to patients with mild-to-moderate LUTS. Also, self-medicating patients often handle their complaints with herbal products. Many patients aim to avoid synthetic drugs for fear of sexual functional side effects and a negative impact on their quality of life. For the elderly, vasoactive comedications might become an issue. When taking plant extracts, patients experience an acceptable symptomatic relief similar to that achieved with synthetics but without side effects. Key Messages: In shared decision-making for purely symptomatic treatment, a low risk of side effects takes priority. We propose to consider patient preferences in the treatment of mild-to-moderate LUTS in men with a low risk of disease progression. We found a consensus that pumpkin seed soft extract adds to the therapeutic armamentarium for patients who cannot or do not want to apply synthetic drugs.

Reoperation Rates and Mortality After Transurethral and Open Prostatectomy in a Long-term Nationwide Analysis: Have We Improved Over a Decade?

OBJECTIVE: To assess long-term reoperation rates and mortality after transurethral resection of the prostate (TURP) and open prostatectomy (PE) as therapy for lower urinary tract symptoms due to benign prostatic enlargement. METHODS: The present study analyzes a nationwide database of all patients who underwent TURP/open PE during 2002-2006 and who were followed up for 8 years. Actuarial cumulative incidences of reoperation (TURP, urethrotomy, bladder neck incision) and death were calculated. Data were provided by the Austrian Public Health Institute. This series was compared with a previously published almost equally sized nationwide cohort that underwent surgery during 1992-1996 in Austria. RESULTS: Between 2002 and 2006, a total of 21,674 patients underwent TURP (n = 20,388) or open PE (n = 1,286). At 8 years, the re-TURP rate after primary TURP was 8.3% vs 4.3% after open PE. The re-TURP rate was higher in the 80+ cohort. The overall endourological reintervention rate at 8 years was 12.7% for TURP and 8.8% for open PE. Reintervention rates did not improve compared with the 1992-1996 series. The 30-day in-hospital mortality rate was 0.1% for TURP and 0.2% for open PE. Mortality rates improved by approximately 20% compared with the 1992-1996 series. CONCLUSION: In Austria, TURP rates remained stable between 1992 and 2006, paralleled by a 50% decline of open PE. Within a decade, mortality rates declined by 20%, yet reintervention rates remained unchanged.

Medical Treatment of Nocturia in Men with Lower Urinary Tract Symptoms: Systematic Review by the European Association of Urology Guidelines Panel for Male Lower Urinary Tract Symptoms.

CONTEXT: The treatment of nocturia is a key challenge due to the multi-factorial pathophysiology of the symptom and the disparate outcome measures used in research. OBJECTIVE: To assess and compare available therapy options for nocturia, in terms of symptom severity and quality of life. EVIDENCE ACQUISITION: Medical databases (Embase, Medline, Cochrane Systematic Reviews, Cochrane Central) were searched with no date restriction. Comparative studies were included which studied adult men with nocturia as the primary presentation and lower urinary tract symptoms including nocturia or nocturnal polyuria. Outcomes were symptom severity, quality of life, and harms. EVIDENCE SYNTHESIS: We identified 44 articles. Antidiuretic therapy using dose titration was more effective than placebo in relation to nocturnal voiding frequency and duration of undisturbed sleep; baseline serum sodium is a key selection criterion. Screening for hyponatremia (< 130 mmol/l) must be undertaken at baseline, after initiation or dose titration, and during treatment. Medications to treat lower urinary tract dysfunction (α-1 adrenergic antagonists, 5-α reductase inhibitors, phosphodiesterase type 5inhibitor, antimuscarinics, beta-3 agonist, and phytotherapy) were generally not significantly better than placebo in short-term use. Benefits with combination therapies were not consistently observed. Other medications (diuretics, agents to promote sleep, nonsteroidal anti-inflammatories) were sometimes associated with response or quality of life improvement. The recommendations of the Guideline Panel are presented. CONCLUSIONS: Issues of trial design make therapy of nocturia a challenging topic. The range of contributory factors relevant in nocturia makes it desirable to identify predictors of response to guide therapy. Consistent responses were reported for titrated antidiuretic therapy. For other therapies, responses were less certain, and potentially of limited clinical benefit. PATIENT SUMMARY: This review provides an overview of the current drug treatments of nocturia, which is the need to wake at night to pass urine. The symptom can be caused by several different medical conditions, and measuring its severity and impact varies in separate research studies. No single treatment deals with the symptom in all contexts, and careful assessment is essential to make suitable treatment selection.

A Relevant Midterm (12 Months) Placebo Effect on Lower Urinary Tract Symptoms and Maximum Flow Rate in Male Lower Urinary Tract Symptom and Benign Prostatic Hyperplasia-A Meta-analysis.

OBJECTIVE: To assess the mid- to long-term placebo effect of the medical and instrumental management of male lower urinary tract symptoms. This is generally a long-term treatment strategy. Therefore, knowledge on the mid- to long-term placebo effect is of considerable interest. The paucity of data on this topic prompted us to investigate this issue in a meta-analysis. METHODS: All randomized controlled trials (RCTs) with the indication of benign prostatic hyperplasia and lower urinary tract symptoms containing a placebo- or sham treatment arm and with a follow-up of 12 months were eligible. The 12-month effect of placebo or sham treatment on the International Prostate Symptom Score (the quality-of-life question was not analyzed herein) and the American Urological Association Symptom Score and on the maximum flow rate was quantified. RESULTS: A total of 25 RCTs with 10.587 patients were eligible. Twenty-three studies were placebo controlled (plant extracts: n = 4, 5α-reductase inhibitors [5ARIs]: n = 9, α-blocker: n = 5, combination therapy of 5ARI and α-blocker: n = 3, and intraprostatic botulinum toxin A injection: n = 2), and 2 RCTs with transurethral microwave thermotherapy (TUMT) had a sham treatment arm. At 12 months, the mean International Prostate Symptom Score improved by a mean of 4.4 points under placebo or sham treatment with a range of 0.7-6.8 points: plant extracts, -3.6; 5ARI, -3.4; α-blocker, -4.3; combination therapy, -4.3; botulinum toxin A, -3.9; and TUMT, -6.8. The mean maximum flow rate improvement at 12 months under placebo or sham was not relevant (+0.8 mL/s), yet there were remarkable differences between trials: plant extracts, -0.3 mL/s; 5ARI, +0.8 mL/s; α-blocker, +1.1 mL/s; combination therapy, +1.4 mL/s; and TUMT, +1.0 mL/s. CONCLUSION: This meta-analysis demonstrates the mid-term placebo effect on lower urinary tract function, particularly concerning subjective improvement. The degree of the placebo effect varies considerable between studies even at 12 months.

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.

CONTEXT: A number of transurethral ablative techniques based on the use of innovative medical devices have been introduced in the recent past for the surgical treatment of benign prostatic obstruction (BPO). OBJECTIVE: To conduct a systematic review of the literature and a meta-analysis of available randomized controlled trials (RCTs), and to evaluate the efficacy and safety of transurethral ablative procedures for BPO. EVIDENCE ACQUISITION: A systematic literature search was performed for all RCTs comparing any transurethral surgical technique for BPO to another between 1992 and 2013. Efficacy was evaluated after a minimum follow-up of 1 yr based on International Prostate Symptom Score, maximum flow rate, and postvoid residual volume. Efficacy at midterm follow-up, prostate volume, perioperative data, and short-term and long-term complications were also assessed. Data were analyzed using RevMan software. EVIDENCE SYNTHESIS: A total of 69 RCTs (8517 enrolled patients) were included. No significant difference was found in terms of short-term efficacy between bipolar transurethral resection of the prostate (B-TURP) and monopolar transurethral resection of the prostate (M-TURP). However, B-TURP was associated with a lower rate of perioperative complications. Better short-term efficacy outcomes, fewer immediate complications, and a shorter hospital stay were found after holmium laser enucleation of the prostate (HoLEP) compared with M-TURP. Compared with M-TURP, GreenLight photoselective vaporization of the prostate (PVP) was associated with a shorter hospital stay and fewer complications but no different short-term efficacy outcomes. CONCLUSIONS: This meta-analysis shows that HoLEP is associated with more favorable outcomes than M-TURP in published RCTs. B-TURP and PVP have resulted in better perioperative outcomes without significant differences regarding efficacy parameters after short-term follow-up compared with M-TURP. Further studies are needed to provide long-term comparative data and head-to head comparisons of emerging techniques. PATIENT SUMMARY: Bipolar transurethral resection of the prostate, photovaporization of the prostate, and holmium laser enucleation of the prostate have shown efficacy outcomes comparable with conventional techniques yet reduce the complication rate. The respective role of these new options in the surgical armamentarium needs to be refined to propose tailored surgical treatment for benign prostatic obstruction relief.

Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement.

CONTEXT: There is a continuous decline in the number of transurethral resections of the prostate (TURP) and an increase use of minimally invasive surgical therapy (MIST) for lower urinary tract symptoms resulting from benign prostatic enlargement. Current results from randomised controlled trials (RCT) and methodologically sound prospective studies suggest that some of the proposed procedures have the potential to replace TURP. OBJECTIVE: To determine the contemporary status of TURP and of the currently most commonly applied transurethral MISTs: (1) bipolar TURP, (2) bipolar transurethral vaporisation of the prostate (bipolar TUVP), (3) holmium laser enucleation of the prostate (HoLEP), and (4) potassium-titanyl-phosphate (KTP) laser vaporisation of the prostate. EVIDENCE ACQUISITION: This meta-analysis was based on a systematic Medline search assessing the period 1997-2009. All RCTs comparing TURP and the most commonly discussed ablative treatments were included. The end points of our analyses were functional outcomes and treatment-related adverse events. EVIDENCE SYNTHESIS: Twenty-seven publications involving 23 different RCTs with a total of 2245 patients provided the highest level of evidence available (level 1b) and were fully assessed. Meta-analysis was conducted with SAS v.9.1.3 (SAS Institute, Cary, NC, USA). Forest plots were produced using the R software. Pooled odds ratios and 95% confidence intervals were calculated between various operative techniques versus TURP. Functional results between the specific transurethral procedures versus TURP were summarised as differences in means. CONCLUSIONS: This meta-analysis demonstrates statistically comparable efficacy and overall morbidity for MISTs versus contemporary TURP. Type, category (minor vs major), and the number of complications (safety profile) vary specifically for each of the different transurethral techniques. We feel that the individual patient's clinical profile should be carefully assessed to identify the most appropriate transurethral technique.

A review of the recent evidence (2006-2008) for 532-nm photoselective laser vaporisation and holmium laser enucleation of the prostate.

CONTEXT: Holmium laser enucleation of the prostate (HoLEP) and 532-nm laser vaporisation of the prostate (with potassium titanyl phosphate [KTP] or lithium borate [LBO]) are promising alternatives to transurethral resection of the prostate (TURP) and open prostatectomy (OP). OBJECTIVE: To assess safety, efficacy, and durability by analysing the most recent evidence of both techniques, aiming to identify advantages, pitfalls, and unresolved issues. EVIDENCE ACQUISITION: A Medline search of recently published data (2006-2008) regarding both techniques over the last 2 yr (January 2006 to September 2008) was performed using evidence obtained from randomised trials (level of evidence: 1b), well-designed controlled studies without randomisation (level of evidence: 2a), individual cohort studies (level of evidence: 2b), individual case control studies (level of evidence: 3), and case series (level of evidence: 4). EVIDENCE SYNTHESIS: In the last 2 yr, several case-control and cohort studies have demonstrated reproducibility, safety, and efficacy of HoLEP and 80-W KTP laser vaporisation. Four randomised controlled trials (RCTs) were available for HoLEP, two compared with TURP and two compared with OP, with follow-up >24 mo. Results confirmed general efficacy and durability of HoLEP, as compared with both standard techniques. Only two RCTs were available comparing KTP laser vaporisation with TURP with short-term follow-up, and only one RCT was available comparing KTP laser vaporisation with OP. The results confirmed the overall low perioperative morbidity of KTP laser vaporisation, although efficacy was comparable to TURP in the short term, despite a higher reoperation rate. CONCLUSIONS: Although they are at different points of maturation, KTP or LBO laser vaporisation and HoLEP are promising alternatives to both TURP and OP. Sufficient data proves HoLEP's durability for most prostate sizes at long-term follow-up; KTP laser vaporisation needs further evaluation to define the reoperation rate. Increasing the number of quality prospective RCTs with adequate follow-up is mandatory to tailor each technique to the right patient.

Plant extracts: sense or nonsense?

PURPOSE OF REVIEW: To assess the current role of plant extracts in the medical management of lower urinary tract symptoms due to benign prostatic enlargement/benign prostatic obstruction. RECENT FINDINGS: In 2006, two clinical trials meeting the WHO benign prostatic hyperplasia consensus conference criteria (randomized against placebo/standard therapy, study duration 12 months) were published. One trial compared a saw palmetto extract with placebo. This industry-independent trial published in the New England Journal of Medicine was negative, that is, this saw palmetto extract had no effect on symptoms, Qmax and postvoid residual volume. In another trial, a saw palmetto/urtica combination was compared with tamsulosin. After 12 months, the improvement of symptoms was identical in both study arms. No detailed data were presented, however, on Qmax, postvoid residual or prostate volume. The biological mechanisms of plant extracts in vivo are still unknown and the numerous metaanalyses cannot supplement high-quality prospective trials. SUMMARY: Further prospective studies according to WHO benign prostatic hyperplasia standards are required to reliably determine the role of plant extracts in contemporary lower urinary tract symptoms management and to be able to answer the question in the title: 'plant extracts: sense or nonsense?' Plant extracts are currently not recommended by the American and European Association of Urology benign prostatic hyperplasia guidelines.