Multicentre prospective evaluation of the learning curve of holmium laser enucleation of the prostate (HoLEP).

OBJECTIVES: To describe the step-by-step learning curve of the holmium laser enucleation of the prostate (HoLEP) surgical technique. SUBJECTS/PATIENTS AND METHODS: A prospective, multicentre observational study was conducted, involving surgeons experienced in transurethral resection of the prostate and open prostatectomy but never having performed HoLEP. The main judgment criterion was the ability of the surgeon to perform four consecutive successful procedures, defined by the following: complete enucleation and morcellation within <90 min, without any conversion to standard transurethral resection of the prostate (TURP), with acceptable stress, and with acceptable difficulty (evaluated by Likert scales). Each surgeon included 20 consecutive cases. RESULTS: Of nine centres, three abandoned HoLEP before the end of the study due to complications, and one was excluded for treating patients off protocol. Only one centre achieved the main judgment criterion of four consecutive successful HoLEP procedures. Overall, the procedures were successfully performed in 43.6% of cases. Reasons for unsuccessful procedures were mainly operative time >90 min (n = 51), followed by conversion to TURP (n = 14), incomplete morcellation (n = 8), significant stress (n = 9), or difficulty (n = 14) during HoLEP. Ignoring operating time, 64% of procedures were successful and four out of five centres did four consecutive successful cases. Of the five centres that completed the study, four chose to continue HoLEP. CONCLUSION: Even in a prospective training structure, HoLEP has a steep learning curve exceeding 20 cases, with almost half of our centres choosing to abandon or not to continue with the technique. Operating time and difficulty of the enucleation seem the most important problems for a beginner. A more intensely mentored and structured mentorship programme might allow safer adoption of the procedure.

Ex vivo comparison of available morcellation devices during holmium laser enucleation of the prostate through objective parameters.

UNLABELLED: BACKGROUND and Purpose: Holmium laser enucleation of the prostate (HoLEP) is a recognized option for surgical management of benign prostatic hyperplasia (BPH). While laser parameters and enucleation techniques have been widely investigated, morcellation techniques remain poorly evaluated in the literature. Our goal was to objectively evaluate the available devices used for morcellation during HoLEP. MATERIAL AND METHODS: An in vitro evaluation of two morcellators (Lumenis and Wolf) and two nephroscopes (Wolf and Storz) was conducted. For morcellators, the following parameters were assessed: Aspiration power (time to aspirate 1 L of water), morcellation power (g of baked chicken meat morcellated in 2 minutes), and visual control of the cutting part of the device (visible or not visible). For nephroscopes, data collected were: Field of vision (measured on a 4 cm distant sight) and irrigation flow (time needed to drain a 3-liter bag of water suspended at 1 m of height). RESULTS: For the Wolf and Lumenis morcellators, aspiration power parameters were 20.4 mL/s and 22.2 mL/s, and morcellating power parameters were 2.5 g and 6 g of tissue per minute, respectively. The cutting part of the Wolf morcellator was permanently under control during the procedure, whereas the distal part of the cutting device was out of vision control with the Lumenis. Evaluation of Storz and Wolf nephroscopes showed that field of vision was larger with the Storz, and irrigation flow was 0.35 and 0.52 L/min, respectively. CONCLUSIONS: The Storz nephroscope has a greater field of vision but less important blood flows. The Lumenis morcellator is faster than the Wolf morcellator. These objective data could set up the basis for a prospective trial comparing the two devices.

Management of lower urinary tract symptoms related to benign prostatic hyperplasia in real-life practice in france: a comprehensive population study.

BACKGROUND: Male lower urinary tract symptoms (LUTS) are one of the most treated diseases, but little is known about patient trajectories in current clinical practice. OBJECTIVE: To describe the dynamic treatment patterns of LUTS presumably due to benign prostatic obstruction (BPO). DESIGN, SETTINGS, AND PARTICIPANTS: All prescriptions of α1-adrenergic receptor blocking agents (α1-blockers), 5α-reductase inhibitors (5-ARIs), and phytotherapy, and all surgeries related to BPO performed in France from 2004 to 2008 were identified using two distinct administrative claim databases maintained by the National Health Insurance system that covers the entire population. After linking the two data sets, all consecutive treatment events were analyzed for each patient. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Drug prescription details were assessed for each year, region, and prescriber qualification. Medical treatment initiation, interruption, evolution, and events after surgical management (hospital stay, reoperation, complication rates, and subsequent medical prescriptions) were also investigated. RESULTS AND LIMITATIONS: Overall, 2 620 269 patients were treated within 5 yr, with important geographic variations. Medical treatment was interrupted for approximately 16% of patients. The α1-blockers were prescribed most frequently, but phytotherapy surprisingly accounted for 27% of all monotherapies and 54% of all combination therapies. General practitioners and urologists (92% and 3.7% of overall prescribers, respectively) exhibited a similar prescription profile. Treatment initiation was medical in 95.4% of cases, consisting primarily of monotherapy using α1-blockers (60.3%), phytotherapy (31.8%), or 5-ARIs (7.9%). Treatment was modified at extremely high rates within 12 mo of initiation (8.7%, 14.6%, and 12.9%, respectively). The median hospital stay for surgical management was far higher than in clinical trials. Long-term surgical complications and reoperation rates favored open prostatectomy. Incidence of pharmacologic treatment after surgery was as high as 13.8% at 12 mo. CONCLUSIONS: This unique dynamic evaluation of clinical practice revealed unexpected results that contrast with previously published evidence from clinical trials. This approach may merit monitored and targeted measures to improve the level of care in the field.

Prospective, multidimensional evaluation of sexual disorders in men after laser photovaporization of the prostate.

INTRODUCTION: A few studies have investigated the impact of photovaporization of the prostate (PVP) on sexual function and were mainly focused on erectile function. AIMS: To comprehensively evaluate the impact of PVP on sexual function. METHODS: A prospective evaluation involved sexually active patients needing surgical relief of bladder outlet obstruction due to benign prostatic enlargement in a single center between August 2007 and November 2011. All patients underwent PVP using the GreenLight HPS™ 120W system (AmericanMedicalSystems, Minnetonka, MN, USA). MAIN OUTCOME MEASURES: Patients were evaluated preoperatively and postoperatively by International Prostate Symptom Score (I-PSS), I-PSS question 8, uroflowmetry parameters (maximum urinary flow rate [Qmax ] and postvoid residual [PVR] volume), Danish Prostate Symptom Score Sexual items (DAN-PSSsex), and overall sexual satisfaction using a seven-grade Likert scale. Operative parameters and postoperative complications were also assessed. Preoperative and postoperative values were compared using the Pearson chi-square test and the Wilcoxon paired test. A multivariable model was used to investigate the determinants of variation of global sexual satisfaction. RESULTS: One hundred and two consecutive patients with 12-month follow-up data were included in the analysis. Urinary parameters (I-PSS, Qmax , and PVR) were significantly improved compared with preoperative values. Compared with baseline, postoperative erection symptom score was not significantly different, whereas ejaculation symptom score was significantly worse. Global DAN-PSSsex score was unchanged, but DAN-PSSsex symptom score was worse (P = 0.04) and DAN-PSSsex bother score was significantly improved (P < 0.0001). Global sexual satisfaction was significantly improved compared with baseline (P = 0.02) and was significantly associated with I-PSS but not with erection and ejaculation score in a multivariable model. CONCLUSION: Ejaculation is the main sexual function impacted by PVP. Despite this, sexual satisfaction and bother due to sexual symptoms were significantly improved, probably due to the positive impact of urinary symptom relief.

Prospective short-term evaluation of transurethral needle ablation procedure in an ambulatory setting.

OBJECTIVE: To assess the results of transurethral needle ablation (TUNA) (Prostiva®, Medtronic, France) performed in an ambulatory setting in men with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A multicenter open-label study was conducted. Short-term success was defined by ability to leave the hospital on the evening of the intervention, and absence of rehospitalization due to complications during the first postoperative month. Sexual and urinary functions were evaluated by validated questionnaires. RESULTS: The procedure was successful in 44/49 patients. Sexual and ejaculatory function was not affected or slightly improved in the majority of patients. Urinary parameters improved with a 32% decrease in the International Prostate Symptom Score. At 1 month postoperation, more than 80% of patients were satisfied, and 36/41 patients were prepared to undergo the procedure again if needed. Our study was limited by the short follow-up duration. CONCLUSIONS: TUNA can be successfully performed in an ambulatory setting under local and/or general anesthesia with a high level of patient satisfaction and a low short-term morbidity, especially on sexual function. Thus, the procedure is a suitable mini-invasive option for patients who cannot/do not want to take medical therapy or undergo invasive surgical procedures, or want to preserve their sexual function.

Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial.

BACKGROUND: Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking. OBJECTIVE: To assess the noninferiority of PVP compared with transurethral resection of the prostate (TURP) on urinary symptoms and the superiority of PVP over TURP on length of hospital stay. DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized controlled trial was conducted. INTERVENTION: Patients underwent monopolar TURP or PVP with the GreenLight HPS 120-W laser. MEASUREMENTS: International Prostate Symptom Score (IPSS), Euro-QOL questionnaire, uroflowmetry, Danish Prostate Symptom Score Sexual Function Questionnaire, sexual satisfaction, and adverse events were collected at 1, 3, 6, and 12 mo. The two groups were compared using the 95% confidence interval (CI) of median difference for testing noninferiority of the IPSS at 12 mo and the student t test for testing the difference in length of hospital stay. RESULTS AND LIMITATIONS: A total of 139 patients (70 vs 69 men in each group) were randomized. Median IPSS scores at 12-mo follow-up were 5 (interquartile range [IQR]: 3-8) for TURP versus 6 (IQR: 3-9) for PVP, and the 95% CI of the difference of the median was equal to -2 to 3. Because the upper limit of the 95% CI was >2 (the noninferiority margin), the hypothesis of noninferiority could not be considered demonstrated. Median length of stay was significantly shorter in the PVP group than in the TURP group, with a median of 1 (IQR: 1-2) versus 2.5 (IQR: 2-3.5), respectively (p<0.0001). Uroflowmetry parameters and complications were comparable in both groups. Sexual outcomes were slightly better in the PVP group without reaching statistical significance. CONCLUSIONS: The present study failed to demonstrate the noninferiority of 120-W GreenLight PVP versus TURP on prostate symptoms at 1 yr but showed that PVP was associated with a shorter length of stay in the hospital. TRIAL REGISTRATION: NCT01043588.

Transurethral plasma vaporization of the prostate: 3-month functional outcome and complications.

UNLABELLED: Study Type - Therapy (multi-centre cohort). Level of Evidence 2b. OBJECTIVE: To evaluate the early functional outcomes of transurethral plasma vaporization of the prostate (TUVis) in a multicentre study. PATIENTS AND METHODS: A prospective multicentre observational study was conducted in eight urology departments. The inclusion criterion was benign prostatic hyperplasia (BPH) requiring surgical treatment. Patients on anti-coagulant therapy were not excluded. The TUVis procedure was performed according to a classic transurethral resection of the prostate (TURP) scheme following the manufacturer's recommendations. We evaluated subjective functional outcome using self-questionnaires (International Prostate Symptom Score [IPSS] and five-item International Index of Erectile Function [IIEF-5]) and objective criteria (prostate volume, prostate-specific antigen [PSA], uroflowmetry, post residual volume) at baseline and at 1- and 3-month follow-ups. All types of complications were systematically recorded. RESULTS: Despite 52% of patients receiving anticoagulant therapy before surgery, we reported only 3% with haemorrhagic complications, no blood transfusion, a mean catheterization time of 44 h and a mean postoperative stay of 2.9 nights. No significant change in irrigation time, catheter time or hospital stay was observed in patients with or without anticoagulant therapy. The IPSS and bother scores significantly decreased after the 3-month follow-up (57% and 59%, respectively), but the average remaining prostate volume was 29 cc and the tissue ablation rate was only 0.5 cc/min. Three major complications occurred, consisting of two urinary fistulas and one partial bladder coagulation. CONCLUSIONS: The TUVis procedure has a proven fast postoperative recovery time, good short-term functional outcome and good haemostatic efficiency. However, the tissue ablation rate was lower than expected and we encountered three major complications, the mechanisms of which remain unclear. Considering the high energy level required to create the plasma effect, the generator, cable and resectoscope must be carefully checked before each procedure.

Surgical management of BPH in patients on oral anticoagulation: transurethral bipolar plasma vaporization in saline versus transurethral monopolar resection of the prostate.

INTRODUCTION: To compare postoperative outcomes of patients on oral anticoagulation (OA) treated with transurethral plasma vaporization of the prostate in saline water (TUVis) and transurethral resection of the prostate (TURP). MATERIALS AND METHODS: Between January and December 2009, 111 patients on OA therapy were treated with either TURP or TUVis in eight centers. Types of OA and perioperative management were collected. Postoperative outcomes were statistically compared between the two groups. RESULTS: A total of 57 (51%) and 54 (49%) patients were treated with TURP and TUVis, respectively. Types of OA were not significantly different between the two groups, but bladder catheterization prior to surgery was more frequently observed in the TUVis group. Before surgery, 28 patients were treated with warfarin alone, 74 with a platelet aggregation inhibitor (PAI) alone, and 9 with a combination of both. PAI was withdrawn preoperatively in 50 patients. All treatments with warfarin were switched for heparin. Comparison of the two groups showed significantly less hemorrhagic complications after TUVis. Patients treated with TUVis experienced less bladder washouts (2% versus 18%, p = 0.008), less late hematuria (4% versus 19%, p = 0.02), and lower decrease of serum hemoglobin (mean decrease of 0.66 versus 1.47 g/dL, p = 0.02). Postoperative bladder catheterization and hospital stay were significantly shorter, whereas the rate of urinary retention was significantly higher. Three months after surgery, functional results were not significantly different between the two groups. CONCLUSIONS: In patients on OA, TUVis led to significantly less bleeding, as well as shorter bladder catheterization and hospital stay than TURP.

A widespread population study of actual medical management of lower urinary tract symptoms related to benign prostatic hyperplasia across Europe and beyond official clinical guidelines.

BACKGROUND: The estimated prevalence of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in men >50 yr of age is around 30%, similar in all industrialized countries. alpha(1)-Blockers and 5 alpha-reductase inhibitors (5-ARIs) are the two classes of drugs recommended by the European Association of Urology guidelines for the medical management of LUTS/BPH. OBJECTIVE: To compare actual clinical practice across Europe with guidelines, we assessed the use of all BPH-related drugs (alpha(1)-blockers, 5-ARIs, and plants) among European countries with a large-scale quantitative and descriptive study. DESIGN, SETTING, AND PARTICIPANTS: The amounts of BPH-related drugs prescribed in 19 European countries were obtained from the IMS Health database retrospectively from 2004 to 2008. Data were adjusted for each country by the number of people >50 yr of age. MEASUREMENTS: We determined the "prescription index" related to BPH, defined for each drug per country by days of treatment sold per year divided by the number of men at risk divided by 365 d. RESULTS AND LIMITATIONS: From 2004 to 2008, the yearly number of prescriptions was 11.6 million for 74 million people at risk. The global prescription index increased in all countries and was three-fold more important in southern countries than in northern ones. alpha(1)-Blockers are the most widely prescribed drugs, but the share of 5-ARIs is increasing. Phytotherapy prescription is country specific, varying from 0% to 40% of prescriptions and is not recommended by the guidelines. CONCLUSIONS: Major variations were seen among European countries concerning the prescriptions related to BPH, although the prevalence of the disease and the guidelines are similar. These results underline the importance of feedback from actual clinical practice. Analysis of actual prescription levels would complement evidence-based medicine as critical material for public health analysis, recommendations, and health insurance policies.

[Medical management of uncomplicated benign prostatic hyperplasia: a new decision algorithm]. / Prise en charge médicale de l'hypertrophie bénigne de la prostatenoncompliquée: proposition d'un nouvel algorithme décisionnel.

Management of benign prostatic hyperplasia (BPH) is currently undergoing profound changes. Medical treatment is not only symptomatic, but may also seek to modify the natural history of the disease, especially by reducing the risk of acute urinary retention. Medical treatment is no longer limited to a single drug: the combination of 2 different drugs from different treatment categories appears superior to single-drug treatment in some patients. Two instrumental techniques - microwave or radiofrequency thermotherapy, previously proposed as alternatives to surgery - are more appropriate as alternatives to medical treatment. These various items make it possible to construct a decision algorithm that is based at each stage on a decision shared with the patient. This algorithm to provide decision aid in management of uncomplicated symptomatic HBP takes initial disease indicators and other patient indicators into account together with its course under treatment, which has not previously been considered by international guidelines.

[Role of prostatic stents and transurethral microwave thermotherapy in the treatment of voiding disorders related to benign prostatic hyperplasia (CTMH-AFU forum 2005)]. / Place des endoprothèses prostatiques et de la thermothérapie micro-ondes transuréthrales dans le traitement des troubles mictionnels liés à l'HBP? (Forum CTMH-aFU 2005).

Prostatic stents and microwave thermotherapy are minimally invasive techniques for the treatment of voiding disorders related to benign prostatic hyperplasia. A review of the literature evaluates the place of these treatments in 2006. Permanent prostatic stenting is rarely used, but remains a treatment option for patients with obstructive disorders and a formal anaesthetic contraindication. Temporary stenting can be used to predict the effect of resection in selected patients. Finally, microwave thermotherapy, not widely used in France, has a promising clinical efficacy and occupies a place between medical treatment and surgery.

Management of non-complicated BPH: proposition of a renewed decision tree.

Nowadays the management of benign prostatic hypertrophia (BPH) is undergoing striking changes. The standard medical treatments are represented by three families which are the phytotherapy, the alpha-blockers and the 5-alpha-reductase inhibitors. These treatments were deemed as symptomatic and used only as monotherapy. Recent numerous studies bring new assessments on BPH: the medical treatment is able to modify the natural history of BPH especially by reducing the risk of acute urinary retention. Furthermore the association of two different therapeutic classes seems to be more efficient than the use of a monotherapy in some cases. Similarly the place of two instrumental techniques, the thermotherapy by microwaves or by radiofrequencies, previously proposed as alternatives to the surgical treatment seems to find their way rather as alternatives to the medical treatment. These different elements allow building a renewed decision tree which decisions are shared with the patient at each stage. This decision tree of the management of patients having non-complicated BPH symptoms must include initial clinical characteristics of the patient and its disease and the evolution under treatment which has not been yet considered in the international recommendations. It also considers the possibilities of associations with other therapeutic classes.

Other therapies for BPH patients: desmopressin, anti-cholinergic, anti-inflammatory drugs, and botulinum toxin.

The usual treatments of benign prostate hyperplasia (BPH) including the alpha-blockers, the inhibitors of the 5-alpha reductase and the phytotherapy drugs allow significant improvements of the lower urinary tracts symptoms (LUTS). However, some patients are not responders or have side effects due to the treatments. Other therapeutic approaches described in the literature are possible in order to alleviate the LUTS. The anti-cholinergic drugs seem to be efficient against the irritating symptoms even if they are supposed to be contra-indicated when there is BPH. Anti-diuretic hormone could be useful to treat nocturia due to diuresis reversal. Inflammation is a part of the underlying mechanisms of BPH and as such the role of the anti-inflammatory drugs has to be revised. Eventually, botulinum toxin is more and more used for patients with neurological bladder and could also have a role in LUTS. If the coming clinical studies on those different treatments confirm the preliminary results, the learning societies in charge of the guidelines would have to update the decision trees by adding these new therapeutic approaches.