bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.

OBJECTIVE: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.

Tetramodal therapy with transurethral resection followed by chemoradiation in combination with hyperthermia for muscle-invasive bladder cancer: early results of a multicenter phase IIB study.

BACKGROUND: Transurethral resection of bladder tumor (TUR-BT) followed by chemoradiation (CRT) is a valid treatment option for patients with muscle-invasive bladder cancer (MIBC). This study aimed to investigate the efficacy of a tetramodal approach with additional regional hyperthermia (RHT). METHODS: Patients with stages T2-4 MIBC were recruited at two institutions. Treatment consisted of TUR-BT followed by radiotherapy at doses of 57-58.2 Gy with concurrent weekly platinum-based chemotherapy and weekly deep RHT (41-43 °C, 60 min) within two hours of radiotherapy. The primary endpoint was a complete response six weeks after the end of treatment. Further endpoints were cystectomy-free rate, progression-free survival (PFS), local recurrence-free survival (LRFS), overall survival (OS) and toxicity. Quality of life (QoL) was assessed at follow-up using the EORTC-QLQ-C30 and QLQ-BM30 questionnaires. Due to slow accrual, an interim analysis was performed after the first stage of the two-stage design. RESULTS: Altogether 27 patients were included in the first stage, of these 21 patients with a median age of 73 years were assessable. The complete response rate of evaluable patients six weeks after therapy was 93%. The 2-year cystectomy-free rate, PFS, LRFS and OS rates were 95%, 76%, 81% and 86%, respectively. Tetramodal treatment was well tolerated with acute and late G3-4 toxicities of 10% and 13%, respectively, and a tendency to improve symptom-related quality of life (QoL) one year after therapy. CONCLUSION: Tetramodal therapy of T2-T4 MIBC is promising with excellent local response, moderate toxicity and good QoL. This study deserves continuation into the second stage.

Efficacy, safety, and perioperative outcomes of holmium laser enucleation of the prostate-a comparison of patients with lower urinary tract symptoms and urinary retention.

Holmium laser enucleation of the prostate (HoLEP) is a valid treatment option to relieve bladder outlet obstruction in patients with large prostate volumes (PV). Its efficacy, tolerability, and safety are comparable to the ones of other laser treatments of the prostate and resection techniques. However, safety and efficacy of HoLEP have not been compared between patients with and without preoperative urinary retention. We included 350 patients (mean age 71.2 years) who had undergone HoLEP due to lower urinary tract symptoms (LUTS) or urinary retention caused by prostatic hyperplasia. We evaluated the differences in peri- and postoperative outcomes and complications between patients with and patients without preoperative urinary retention. The mean PV was 115 cm3. PV was > 100 cm3 in 61.9% and < 100 cm3 in 38.1% of the patients. Perioperative complications occurred in 23 patients (6.6%), 15 of which (4.3%) required operative revision. We found no significant differences in terms of complication rates between patients with PV > 100 cm3 and patients with PV < 100 cm3. Mean catheterization-duration was 3.3 days. Preoperatively, 140 patients (40%) had a suprapubic or transurethral indwelling catheter; they did not differ from patients without preoperative catheter regarding postoperative catheter removal success rate, early postoperative complications, and functional outcomes. Prostate cancer was diagnosed in 43 patients (12.3%). Median postoperative PSA-decline was 6.1 ug/l (89.8% drop). HoLEP is a safe and effective treatment for patients with LUTS or urinary retention and large PV. PV > 100 cm3 was not associated with higher complication rates or successful catheter-removal. Furthermore, functional outcomes were independent of preoperative catheterization.

Feasibility of freehand MRI/US cognitive fusion transperineal biopsy of the prostate in local anaesthesia as in-office procedure-experience with 400 patients.

BACKGROUND: Transrectal (TR) ultrasound-guided prostate biopsy is one of the most commonly performed urologic procedures worldwide. The major drawback of this approach is the associated risk for infectious complications. Sepsis rates are increasing due to rising antibiotic resistance, representing a global issue. The transperineal (TP) approach for prostate biopsy has recently been adopted at many centres as an alternative to the TR biopsy, and it was shown to be associated with a lower risk for sepsis. The aim of this study was to assess safety and tolerability of TP prostate biopsy performed in local anaesthesia. METHODS: We retrospectively analysed data of patients who had undergone office-based TP prostate biopsy in local anaesthesia, performed by a single surgeon between January 2015 and May 2019. We evaluated the patients' acceptance of the procedure by a pain score, as well as its safety and diagnostic performance. RESULTS: Four hundred patients were included. Median age was 66 years [range, 49-86]. Median prostate-specific antigen (PSA) concentration was 6.4 ng/ml [range, 0.3-1400], median PSA density was 0.15 ng/ml2 [range, 0-31.1] and median prostate volume was 40 ml [range, 6-150]. A total of 118 (29.5%) and 105 (26.2%) patients had orally received two and one doses of 500 mg fluoroquinolone, respectively, and 177 (44.3%) patients did not receive any antibiotic prophylaxis. No infectious complications occurred. Median pain score was 2.0 (range, 0-8). Overall cancer detection rate was 64.5% (258/400). CONCLUSIONS: Freehand TP prostate biopsy in local anaesthesia is a safe, effective and well-tolerated outpatient procedure with a high cancer detection rate. The elimination of infectious complications and its high accuracy make this technique a feasible alternative to the TR approach for the urological office. We assume that the single puncture and our trocar-like access sheath introduction technique diminish tissue trauma and bacterial exposition, and thus contribute to these promising results.

The effect of increased maximum power output on perioperative and early postoperative outcome in photoselective vaporization of the prostate.

BACKGROUND AND OBJECTIVE: Preclinical studies suggest an increased vaporization rate and speed of the 532 nm 180-W XPS GreenLight laser (180-W) compared with the 120-W HPS GreenLight laser (120-W) and the 80-W PV GreenLight laser (80-W). To test the clinical relevance of this observation we analyzed intraoperative data and early postoperative results after photoselective vaporization of the prostate (PVP) with the 180-W, 120-W, and 80-W laser. STUDY DESIGN/MATERIALS AND METHODS: A retrospective pair-to-pair comparison was performed including 80 consecutive patients who underwent PVP for the treatment of benign prostate enlargement with the 180-W, 120-W, and 80-W laser. The groups matched concerning age, prostate volume, PSA-value, and preoperative catheterization. Primary study outcome measurement was PSA-value reduction at 3 months; intraoperative data, perioperative complications, and early postoperative functional course were secondary study outcome measurements. RESULTS: Energy application per case (kJ), preoperative prostate volume (kJ/ml) operating time (kJ/minute), and lasing time (kJ/minute) was significantly higher with the 180-W laser. Prevalence of impaired visibility due to bleeding was comparable between the 180-W and the 120-W laser but significantly lower with 80-W. Duration of hospitalization was shorter with the 180-W laser compared to the former laser systems. During the postoperative course of 3 months voiding parameters and micturition symptoms significantly improved in all groups, the incidence of postoperative dysuria was comparable. Postoperative PSA-value reduction was significantly higher after treatment with the 180-W laser. CONCLUSIONS: With the 180-W laser, higher energy application and higher speed of tissue vaporization leads to increased tissue vaporization compared to the former 120-W and 80-W laser systems. Clinical efficacy and perioperative safety are maintained with the higher powered laser.

Laser prostatectomy of lower urinary tract symptoms due to benign prostate enlargement: a critical review of evidence.

PURPOSE OF REVIEW: Different transurethral prostatic laser systems are available. In 2011, new Oxford evidence levels (LoEs) were published with significant changes compared with the former version. They are easier to use and incorporate more clinical aspects. Randomized trials of laser systems used before 2002, except Holmium laser, were not included in this critical evidence analysis, as these techniques are not in clinical use any more. RECENT FINDINGS: Twenty-five [18 Holmium enucleation of the prostate (HoLEP) and seven photoselective vaporization of the prostate (PVP)] randomized trials covering transurethral electroresection of the prostate or HoLEP, PVP or Thulium laser enucleation were identified. According to evidence levels, there is a large gap in terms of long-term follow-up. The majority of randomised controlled trials are of low quality. Typically with HoLEP, many articles were published covering the same patient population (LoE II). Only one randomised controlled trial was published with Tm:YAG prostatectomy (LoE II) and none with diode lasers (980-1340 nm, LoE IV-V). Large cohort studies (LoE III-IV) provide additional evidence for PVP and HoLEP, typically for subgroups. SUMMARY: In 2011, higher evidence on HoLEP and PVP has been published. Evidence levels for HoLEP and PVP are comparable with meta-analysis (LoE II). However, evidence that laser prostatectomy is better than transurethral electroresection of the prostate in terms of efficacy is lacking (LoE II). All lasers are safer in terms of perioperative bleeding (LoE II).

Complications of laser prostatectomy: a review of recent data.

INTRODUCTION: Laser techniques for the treatment of bladder outlet obstruction (BOO) due to benign prostate enlargement (BPE) have emerged as an alternative to transurethral resection of the prostate (TURP) and open prostatectomy (OP). MATERIALS AND METHODS: A Medline search over the past 4 years was performed to assess the safety, intra- and postoperative morbidity of various laser techniques. RESULTS: Data on holmium laser enucleation of the prostate (HoLEP) show the highest grade of evidence with two meta-analyses available and prove the low intra- and postoperative morbidity with reproducible long-term results. Photoselective vaporization of the prostate (PVP) with the Greenlightlaser (potassium titanyl phosphate, KTP or lithium borate, LBO) is characterized by excellent haemostatic properties in patients with or without oral anticoagulation. Long-term results show a reoperation rate comparable with TURP; however, there is a lack of randomized trials. Various types of diode lasers with different wavelengths are available for laser vaporization; despite their favourable haemostatic properties, a higher invasion depth seems to result in necrosis of the tissue leading to a higher rate of reoperation. Thulium-laser resection of the prostate shows promising intra- and postoperative morbidity, but data are limited and initial results need to be confirmed in large-scale trials. CONCLUSION: In summary, HoLEP- and KTP-, or LBO-laser vaporization of the prostate are the most mature techniques of laser prostatectomy and treatment alternatives to TURP and OP, whereas the clinical value and durability of procedures with diode laser systems and the thulium laser need to be confirmed in high-quality prospective RCTs.

Comparison of potassium-titanyl-phosphate laser vaporization of the prostate and transurethral resection of the prostate: update of a prospective non-randomized two-centre study.

OBJECTIVES: To evaluate the intermediate-term clinical efficacy and the rate of complications in 80 W photoselective vaporization of the prostate (PVP) with the potassium-titanyl-phosphate laser (Greenlight, (AMS, Minnetonka, MN, USA) compared with transurethral resection of the prostate (TURP) in a prospective non-randomised two-centre study. PATIENTS AND METHODS: From December 2003 to August 2006, 396 patients (PVP 269, TURP 127) with lower urinary tract symptoms secondary to benign prostatic hyperplasia were included in the study. There was a significant difference in mean age (72 years for PVP vs 68 for TURP, P = 0.001). Patients were therefore stratified in age categories (<70, 70-80, >80 years) and compared for perioperative variables, functional outcome and complications, with a follow-up of up to 24 months. RESULTS: The mean prostate size was greater (overall, 62 vs 48 mL, P < 0.001) and mean operative duration longer (overall 72 vs 53 min; P = 0.001) for PVP in all age categories. The rate of intraoperative bleeding (3% vs 11%), blood transfusions (0% vs 5.5%) and capsule perforations (0.4% vs 6.3%), and early postoperative clot retention (0.4% vs 3.9%) was significantly lower for PVP. Hospitalization time was significantly shorter in the PVP group for patients aged <70 years (3.0 vs 4.7 days) and 70-80 years (4.0 vs 5.0 days; P = 0.001). The improvement of peak urinary flow rate was higher after TURP for any age category. The International Prostate Symptom Score and postvoid residual volume during the follow-up showed no significant difference. After 12 months the overall prostate size reduction was 63% (-30 mL) after TURP and 44% (-27 mL) after PVP. The rate of repeat TURP/PVP was higher in the PVP group (6.7% vs 3.9%, not significant) within the follow-up of up to 2 years. The incidence of urethral and bladder neck strictures was comparable. CONCLUSIONS: PVP was more favourable in terms of perioperative safety. Although patients assigned for PVP were older and had larger prostates, PVP resulted in a similar functional outcome. Further follow-up is needed to draw final conclusions about the long-term efficacy of PVP.

Safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing oral anticoagulation.

OBJECTIVES: Ongoing oral anticoagulation (OA) contraindicates transurethral electroresection of the prostate. We evaluated the safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing OA with coumarin derivatives, aspirin, or clopidogrel, complaining of symptomatic benign prostatic hyperplasia (BPH). METHODS: We evaluated perioperative parameters, functional outcome, and adverse events up to 24 mo postoperatively of patients on OA, and compared results with 92 men at normal risk without anticoagulant therapy undergoing PVP for the same indication (control). RESULTS: Within 40 mo, 116 men on OA were included, with 31% (n=36) receiving coumarin derivatives; 61% (n=71), aspirin; and 8% (n=9), clopidogrel. Mean prostate volume (62+/-34ml vs. 57+/-25ml; p=0.289) and mean operation time (67+/-28min vs 63+/-29min; p=0.313) were comparable with control. We observed no bleeding complications necessitating blood transfusions. Average postoperative decrease of haemoglobin was 8.6% for patients on OA versus 8.8% for control. At 3, 6, 12, and 24 mo postoperatively, improvement of the International Prostate Symptom Score ranged from 60-70%; postvoid residual volume, 80-88%; and average maximum urinary flow rate, 116-140%, respectively. Postoperative complications were low and comparable with control. CONCLUSIONS: PVP is characterized by excellent haemostatic properties and very low intraoperative complication rate even in patients on OA. On the basis of our perioperative results, we recommend PVP as first-line procedure for patients with symptomatic BPH at high risk of bleeding.

Photoselective vaporization of the prostate: subgroup analysis of men with refractory urinary retention.

OBJECTIVES: The purpose of this study was to evaluate the feasibility and efficacy of photoselective vaporization of the prostate (PVP) in patients with refractory urinary retention (RUR) secondary to benign prostate hyperplasia (BPH). METHODS: Perioperative data, postoperative outcomes, and adverse events within 24 months in 70 patients with RUR were compared to 113 men with no urinary retention (NUR) before surgery. RESULTS: Follow-up for the two groups was as follows (RUR vs. NUR at 1, 3, 6, 12, and 24 months): peak urinary flow rate: 16.9 vs. 19.4 ml/s, 16.3 vs. 20.9 ml/s, 17.7 vs. 19.7 ml/s, 18.2 vs. 21 ml/s, and 19.4 vs. 23.3 ml/s; International Prostate Symptom Score: 7.6 vs. 10.7, 7 vs. 7.5, 5.7 vs. 6.2, 5.5 vs. 6.5, and 4.4 vs. 6.5, respectively. Postoperative urinary retention and complication rates were comparable for the two groups. In five patients (2.7%), a reoperation with PVP or transurethral resection of the prostate was necessary. Bladder neck contracture and urethral stricture developed in 0.5% (n=1) and 4.9% (n=9), respectively. CONCLUSION: PVP seems to be a safe and effective surgical tool in patients with RUR caused by prostatic enlargement. The complication rate is comparable to that of patients with NUR before PVP.

Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome.

OBJECTIVES: To compare the early follow-up and perioperative morbidity of photoselective vaporization (PVP) and transurethral resection of the prostate (TURP) in patients (pts.) suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIAL AND METHOD: 101 pts. underwent PVP (n = 64) and TURP (n = 37) in a prospective, non-randomized bi-centre trial. Inclusion criteria were identical at both centres. Primary outcome parameters were maximum urinary flow rate (Q(max)), post-void residual volume (V(res)), International Prostate Symptom Score (IPSS). Secondary outcomes included intraoperative surgical parameters and perioperative and post-discharge morbidity. RESULTS: Baseline characteristics of both groups were similar. Operating time was slightly shorter in the TURP group (p = 0.047). During TURP significant more irrigation solution was used (p < 0.001). Decrease of serum haemoglobin (p = 0.027) and serum sodium (p = 0.013) was larger after TURP. Catheter drainage was removed significant earlier after PVP than after TURP (p < 0.001). Outcome of Q(max), and IPSS were similar in both groups within 6 months. The sort of perioperative complications was different in both groups, however overall cumulative perioperative morbidity was comparable (PVP 39.1% versus TURP 43.2.1%; ns). CONCLUSION: PVP provides excellent intraoperative safety, instant tissue removal, and immediate relief from obstructive voiding symptoms, similar to TURP. Early outcomes 6-months after PVP and TURP are comparable.