Aquablation versus TURP: 5-year outcomes of the WATER randomized clinical trial for prostate volumes 50-80 mL.

INTRODUCTION: To report the 5-year efficacy and safety of Aquablation compared with transurethral resection of the prostate for the management of lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with prostate volumes 50-80 mL. MATERIALS AND METHODS: In a large double-blinded, multicenter, and prospective randomized controlled trial, 96 randomized men with 50-80 mL prostates who underwent Aquablation or transurethral prostate resection were prospectively identified for subgroup analysis. Follow up was performed for up to 5 years. The primary efficacy endpoint was the reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo (CD) postoperative complications grade 1 persistent and grade 2 or higher at 3 months. RESULTS: Both groups had comparable baseline characteristics. Reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow up (-14.1 vs. -10.8, p = 0.02). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 3 months follow up (risk difference of -23.1%). Among recorded adverse events, de novo postoperative ejaculatory dysfunction was notably lower in Aquablation (risk difference of -21.9%), while the risk of bleeding remained similar after 6 months. The surgical and medical retreatment rate at 6 months was also lower in Aquablation (risk difference of -14.4%). CONCLUSIONS: In the 50-80 mL prostate volume subgroup, Aquablation yields superior long-term symptom relief and lower complication rates than standard transurethral resection, with notably lower rates of ejaculatory dysfunction. This further supports the adoption of Aquablation for men with medium-sized prostates.

Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder.

INTRODUCTION: Peripheral nerve stimulation has been demonstrated as a viable alternative to sacral nerve stimulation in managing refractory overactive bladder (OAB). New technologies allow the internalization of tibial nerve stimulators through various apparatuses. One such device, the eCoin, is a small, coin-shaped device that can be implanted adjacent to the tibial nerve that provides pre-programmed stimulation. AREAS COVERED: We will review the literature on eCoin implantation, from proof of concept to mid-term data, with the longest period of follow-up being 12 months. All studies on this technology will be reviewed, along with an analysis of the current state of play in implantable neuromodulators for overactive bladder. Efficacy, durability, adverse events, and viability of eCoin as a long-term management option will be considered. EXPERT OPINION: The eCoin device demonstrates promising early data for efficacy in managing overactive bladder symptoms. Complication rates remain low and are mostly related to wound healing following the initial placement of the device. Research into the continued improvement and modification of the device appears optimistic, but longer-term data still need to be obtained. Indeed, implantable PTNS have a role in the future management of overactive bladder, and devices such as eCoin will still need to prove a long-term benefit to be a mainstay of management.

Experts' recommendations in laser use for the endoscopic treatment of prostate hypertrophy: a comprehensive guide by the European Section of Uro-Technology (ESUT) and Training-Research in Urological Surgery and Technology (T.R.U.S.T.)-Group.

PURPOSE: To identify expert laser settings for BPH treatment and evaluate the application of preventive measures to reduce complications. METHODS: A survey was conducted after narrative literature research to identify relevant questions regarding laser use for BPH treatment (59 questions). Experts were asked for laser settings during specific clinical scenarios. Settings were compared for the reported laser types, and common settings and preventive measures were identified. RESULTS: Twenty-two experts completed the survey with a mean filling time of 12.9 min. Ho:YAG, Thulium fiber laser (TFL), continuous wave (cw) Tm:YAG, pulsed Tm:YAG and Greenlight™ lasers are used by 73% (16/22), 50% (11/22), 23% (5/22), 13.6% (3/22) and 9.1% (2/22) of experts, respectively. All experts use anatomical enucleation of the prostate (EEP), preferentially in one- or two-lobe technique. Laser settings differ significantly between laser types, with median laser power for apical/main gland EEP of 75/94 W, 60/60 W, 100/100 W, 100/100 W, and 80/80 W for Ho:YAG, TFL, cwTm:YAG, pulsed Tm:YAG and Greenlight™ lasers, respectively (p = 0.02 and p = 0.005). However, power settings within the same laser source are similar. Pulse shapes for main gland EEP significantly differ between lasers with long and pulse shape modified (e.g., Moses, Virtual Basket) modes preferred for Ho:YAG and short pulse modes for TFL (p = 0.031). CONCLUSION: Ho:YAG lasers no longer seem to be the mainstay of EEP. TFL lasers are generally used in pulsed mode though clinical applicability for quasi-continuous settings has recently been demonstrated. One and two-lobe techniques are beneficial regarding operative time and are used by most experts.

Aquablation in Patients on Antithrombotics: Assessment of Safety, Postoperative Bleeding Rates and Clinical Outcomes.

OBJECTIVE: To analyze the impact of perioperative antithrombotic use on the bleeding outcomes following Aquablation. METHODS: One hundred sixteen men with who underwent Aquablation as part of the WATER prospective trial (NCT02505919) were assigned to 2 groups based on perioperative antithrombotic status. Antithrombotic cessation and restart timing were based on the surgeon's discretion. Methods of achieving intraoperative hemostasis consisted of no-cautery balloon tamponade or cautery. Primary endpoints included immediate postoperative hematuria rates and changes in hemoglobin. Secondary endpoints included 90-day bleeding complications and nonbleeding postoperative adverse events. RESULTS: Forty-one men took antithrombotic medications in the perioperative period while 75 men had no antithrombotic medication. Preoperative hemoglobin levels were comparable between both groups. Postoperative hemoglobin change from baseline (drop of 1.8 ± 1.5 g/dL among the antithrombotic group vs 1.8 ± 1.7 g/dL among the antithrombotic-naïve group) did not differ between both groups (P = .896). In total, 4 (9.8%) men in the antithrombotic group and 4 (5.3%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 1 complication (P = .451) in the 3-month postoperative period. Eight (19.5%) patients in the antithrombotic group and 11 (14.7%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 2 complication (P = .601), none of which is associated with bleeding in both groups. No men in either group demonstrated de novo erectile dysfunction. One patient (2.4%) in the antithrombotic group and none in the antithrombotic-naïve group required blood products (P = .353). CONCLUSION: Aquablation demonstrates comparable postoperative bleeding outcomes and other adverse effects for men with benign prostatic hypertrophy who are on antithrombotic therapy.

Functional and oncological outcomes after radical prostatectomy in patients with history of surgery for lower urinary tract symptoms related to benign prostatic enlargement: A systematic review with meta-analysis.

BACKGROUND: Outcomes of radical prostatectomy (RP) in men with history of lower urinary tract symptoms related to benign prostatic enlargement (LUTS/BPE) surgery represents a controversial issue. We performed an updated systematic review and meta- analysis evaluating oncological and functional outcomes of RP in this subset of patients. METHODS: Eligible studies were identified from MEDLINE, Web of Science and the Scopus databases. The following outcomes were evaluated: incidence of positive surgical margins (PSM), incidence of biochemical recurrence (BCR), 3-mo and 1-year urinary continence (UC) rates, incidence of nerve-sparing (NS) procedures, 1-year erectile function (EF) recovery rates. We estimated pooled Odds ratios (OR) and 95% confidence intervals (CI) using random effects models. Sub-analyses were performed according to the type of RP and LUTS/BPE surgery. RESULTS: Twenty-five retrospective studies including 11,101 patients undergoing RP were included in the analysis (2113 with history of LUTS/BPE surgery, and 8898 controls). PSM rate was significantly higher in patients with history of LUTS/BPE surgery (OR 1.39, 95% CI 1.18-1.63, p < 0.001). No statistically significant difference in terms of BCR emerged between patients with or without history of LUTS/BPE surgery (OR 1.46, 95% CI 0.97-2.18, p = 0.066). Three-months and 1-year UC rates were significantly lower in patients with previous LUTS/BPE surgery (OR 0.48, 95% CI 0.34-0.68, p < 0.001 and OR 0.44, 95% CI 0.31-0.62, p < 0.001; respectively). Although not statistically significant differences between the two groups emerged in terms of adoption of NS procedures (OR 0.59, 95% CI 0.32-1.12, p = 0.107), 1-year EF recovery was significantly lower in patients with history of LUTS/BPE procedures (OR 0.60, 95% CI 0.40-0.89, p = 0.010). CONCLUSIONS: In conclusions, RP in patients with history of previous LUTS/BPE surgery is associated with increased incidence of PSM, lower UC rates at both 3-months and 1-year follow-up as well as lower rates of EF recovery at 1-year follow-up.

How I Do It: Transperineal prostate biopsy using local anesthetic in an outpatient setting.

Transperineal prostate biopsy (TPPB) is proven to be an effective diagnostic tool for prostate cancer detection. It allows satisfactory sampling of apical and anterior areas which is not well achieved with the transrectal route, without the associated risks of urinary tract infection or sepsis. The main objective of this paper is to describe the technique utilized in our institution to perform transperineal prostate biopsy under local anesthetic in the outpatient clinic setting.

Functional and surgical outcomes of Aquablation in elderly men.

PURPOSE: As benign prostatic hyperplasia (BPH) is an age-related process, growing interest in surgical management for elderly men has emerged. Recently, Aquablation was approved for treatment of BPH associated lower urinary tract symptoms (LUTS) and utilizes robotic ultrasound guided surgeon-controlled waterjet ablation. We assessed the differences in functional and surgical outcomes between elderly and young men undergoing Aquablation for BPH/LUTS. MATERIALS AND METHODS: We retrospectively assessed prospectively collected data from the WATER I (NCT02505919) and WATER II (NCT03123250) clinical trials reporting safety and efficacy of Aquablation in the treatment of LUTS/BPH in men 45-80 years with a prostate between 30 and 80 cc, and 80 cc and 150 cc, respectively. Men ≥ 65 years were defined as elderly and men < 65 years as young. RESULTS: Of 217 patients included, 83 (38.2%) were young and 134 (61.8%) were elderly. Mean age (SD) was 59.3 (± 3.4) years and 71.2 (± 4.2) years for young and elderly men, respectively. At 3 years of follow-up compared to baseline, elderly men showed similar reductions in total IPSS (7.68 points vs 7.12 points, p > 0.05) and similar increases in Qmax (20.6 mL/s vs 19.3 mL/s, p > 0.05) compared to young men. The ejaculatory dysfunction rate was similar for both cohorts (12.0% vs 9.7%, p > 0.05). Elderly men experienced similar annual retreatment rates compared to young men (1.5% vs 0.8% p > 0.05). CONCLUSIONS: Elderly men undergoing Aquablation have similar functional and surgical outcomes as young men. Elderly patient BPH surgical counseling should, therefore, consider Aquablation as a treatment option for LUTS/BPH.

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.

OBJECTIVE: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation. METHODS: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline. RESULTS: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. CONCLUSIONS: The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

WATER vs WATER II 3-Year Update: Comparing Aquablation Therapy for Benign Prostatic Hyperplasia in 30-80 cc and 80-150 cc Prostates.

OBJECTIVE: To compare the outcomes of Aquablation for small-to-moderate (30-80cc) prostates with the outcomes for large (80-150 cc) prostates at 3-year follow up. METHODS: WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45-80 year with a prostate of 30cc-80cc. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80cc-150cc. We compare 36-mo outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation. RESULTS: International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.5 at 36-month, with 36-mo reductions of 14.4 and 16.3 points, respectively (P = .247). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 18.5 cc/sec, respectively (P = .552) at 36-mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 3 year, 98% and 94% of treated patients were BPH medication-free in WATER and WATER II, respectively (P = .038). At 3yr, 96% and 97% of treated patients were free from surgical retreatment in WATER and WATER II, respectively (P = .613). CONCLUSIONS: Three-year follow-up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.

Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

INTRODUCTION: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP. MATERIALS AND METHODS: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years. RESULTS: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm. CONCLUSIONS: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.

Does MOSES Technology Enhance the Efficiency and Outcomes of Standard Holmium Laser Enucleation of the Prostate? Results of a Systematic Review and Meta-analysis of Comparative Studies.

CONTEXT: Holmium laser enucleation of the prostate (HoLEP) is currently the size-independent gold standard for surgical treatment of benign prostate enlargement (BPE). OBJECTIVE: To systematically review the current literature and compare perioperative parameters, early outcomes, and complications after HoLEP with MOSES technology LEP (MoLEP) for BPE. EVIDENCE ACQUISITION: This study was performed according to the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework using the PICOS (Patient, Intervention Comparison, Outcome, Study) model to frame the clinical question. The population was adults undergoing LEP for BPE, with standard HoLEP as the intervention and MoLEP as the comparison. The outcomes were enucleation time, surgical time, haemostasis time, energy used, hospital length of stay (LOS), recatheterisation, urethral stricture rate, and functional outcomes. The study type included randomised, prospective nonrandomised, and retrospective studies. EVIDENCE SYNTHESIS: Seven studies were included for meta-analysis after screening. Mean enucleation time was significantly shorter for MoLEP (mean difference [MD] -7.27 min, 95% confidence interval [CI] -11.26 to -3.28; p = 0.0004). Postoperative LOS was significantly longer in the HoLEP group (MD 0.3 d, 95% CI -0.24-0.85,p<0.0001). Although not statistically significant, there was a trend for higher incidence of recatheterisation (odds ratio [OR] 1.39, 95% CI 0.47-4.09; p = 0.55) and urethral stricture (OR 1.81, 95% CI 0.45-7.37; p = 0.41) in the HoLEP group. The mean maximum peak flow favoured HoLEP (MD 0.95 ml/s, 95% CI -1.66 to 3.57; p = 0.47) and a lower mean postvoid residual volume was noted in the MoLEP group (MD -10.08 ml, 95% CI -53.54 to 33.37; p = 0.65). CONCLUSIONS: MoLEP performed better in terms of intraoperative outcomes compared to standard HoLEP, resulting in shorter enucleation, haemostasis, and total surgical times for similar energy delivered. In addition, postoperative LOS with an early trial of catheter favours MoLEP, making it appealing as a day surgery procedure. PATIENT SUMMARY: We reviewed the literature for early outcomes of laser treatment of the prostate for tissue removal using a MOSES system in comparison to standard treatment with a holmium laser for BPE. We found that the MOSES laser system can improve intraoperative performance, making prostate treatment a same-day discharge surgery.

'Pain-free TRUS B': a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501).

OBJECTIVE: To determine whether the addition of inhaled methoxyflurane to periprostatic infiltration of local anaesthetic (PILA) during transrectal ultrasonography-guided prostate biopsies (TRUSBs) improved pain and other aspects of the experience. PATIENTS AND METHODS: We conducted a multicentre, placebo-controlled, double-blind, randomized phase 3 trial, involving 420 men undergoing their first TRUSB. The intervention was PILA plus a patient-controlled device containing either 3 mL methoxyflurane, or 3 mL 0.9% saline plus one drop of methoxyflurane to preserve blinding. The primary outcome was the pain score (0-10) reported by the participant after 15 min. Secondary outcomes included ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events. RESULTS: The mean (SE) pain scores 15 min after TRUSB were 2.51 (0.22) in those assigned methoxyflurane vs 2.82 (0.22) for placebo (difference 0.31, 95% confidence interval [CI] -0.75 to 0.14; P = 0.18). Methoxyflurane was associated with better scores for discomfort (difference -0.48, 95% CI -0.92 to -0.03; P = 0.035, adjusted [adj.] P = 0.076), whole experience (difference -0.50, 95% CI -0.92 to -0.08; P = 0.021, adj. P = 0.053), and willingness to undergo repeat biopsies (odds ratio 1.67, 95% CI 1.12-2.49; P = 0.01) than placebo. Methoxyflurane resulted in higher scores for drowsiness (difference +1.64, 95% CI 1.21-2.07; P < 0.001, adj. P < 0.001) and dizziness (difference +1.78, 95% CI 1.31-2.24; P < 0.001, adj. P < 0.001) than placebo. There was no significant difference in the number of ≥ grade 3 adverse events. CONCLUSIONS: We found no evidence that methoxyflurane improved pain scores at 15 min, however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

WATER versus WATER II 2-Year Update: Comparing Aquablation Therapy for Benign Prostatic Hyperplasia in 30-80-cm3 and 80-150-cm3 Prostates.

BACKGROUND: Surgical options are limited when treating large (>80 cm3) prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Open simple prostatectomy remains the most common procedure performed for large prostates. There is a need for novel surgical approaches with shorter learning curves and effective treatment. Aquablation could be this novel tool. OBJECTIVE: To compare the outcome of Aquablation for 30-80-cm3 prostates with the outcome for 80-150-cm3 prostates at 2-yr follow-up. DESIGN SETTING AND PARTICIPANTS: We used data from two trials. WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and transurethral resection of the prostate in the treatment of LUTS/BPH in men aged 45-80 yr with a prostate of 30-80 cm3. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80-150 cm3. INTERVENTION: Aquablation, an ultrasound-guided, robotically executed waterjet ablative procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We compared 24-mo outcomes between 116 WATER and 101 WATER II study subjects. Student's t test or a Wilcoxon test was used to compare continuous variables and Fisher's test for categorical variables. RESULTS AND LIMITATIONS: The International Prostate Symptom Score (IPSS) reductions at 24 mo was 14.5 points for WATER and 17.4 points for WATER II (p = 0.31). At baseline, the maximum urinary flow rate (Qmax) was 9.4 and 8.7 cm3/s in WATER and WATER II, improving to 20.5 and 18.2 cm3/s, respectively (p = 0.60) at 24 mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 2 yr, the surgical retreatment rate was 4% in WATER and 2% in WATER II. CONCLUSIONS: Aquablation is effective in patients with a prostate of 30-80 cm3 and patients with a prostate of 80-150 cm3 treated for LUTS/BPH, with comparable outcomes in both groups. It has low complication and retreatment rates at 2 yr of follow-up, with durable improvements in functional outcome. PATIENT SUMMARY: Outcomes of Aquablation for both small-to-moderately-sized and large prostates are similar and sustainable at 2 yr of follow-up.

Erectile Function Following Surgery for Benign Prostatic Obstruction: A Systematic Review and Network Meta-analysis of Randomised Controlled Trials.

CONTEXT: Benign prostatic obstruction (BPO) is associated with sexual dysfunction. Furthermore, numerous BPO interventions may themselves impact sexual function. OBJECTIVE: To perform a systematic review with network meta-analysis to evaluate how BPO interventions affect erectile function. EVIDENCE ACQUISITION: Three databases were searched for randomised controlled trials (RCTs) comparing surgical interventions for BPO. The primary outcome was postoperative International Index of Erectile Function-5 (IIEF-5) score at ten time points up to 72 mo. A random-effects Bayesian network meta-analysis with meta-regression was performed. In comparison to monopolar transurethral resection (mTURP), the mean difference (MD) with 95% credible interval (CrI) and rank probability (rank p) were calculated for interventions. The mean baseline score was studied in meta-regression. τ2 values were used to quantify heterogeneity. EVIDENCE SYNTHESIS: A total of 48 papers (33 RCTs, 5159 patients, 16 interventions) were included. Prostatic urethral lift (PUL) ranked highest at 1 mo (MD 3.88, 95% CrI -0.47 to 8.25; rank p = 0.742), 6 mo (MD 2.43, 95% CrI -0.72 to 5.62; rank p = 0.581), 12 mo (MD 2.94, 95% CrI -0.26 to 6.12, rank p = 0.782), and 24 mo (MD 3.63, 95% CrI 0.14 to 7.11; rank p = 0.948), at which point statistical significance was reached. At time points up to 60 mo, there were no statistically significant comparisons for other interventions. Analyses were not possible at 18, 48, or 72 mo. ß did not reach statistical significance in meta-regression. τ2 was highest at 1 mo (0.56) and 60 mo (0.55). CONCLUSIONS: PUL ranked highly and resulted in erectile function improvement at 24 mo compared to mTURP, but direct evidence is lacking. We did not observe significant differences in erectile function following other interventions up to 60 mo. Owing to heterogeneity, our conclusions are weakest at 1 and 60 mo. Further RCTs comparing sexual function outcomes are recommended, such as PUL versus holmium laser or bipolar enucleation. PATIENT SUMMARY: Different surgical treatments can be used to treat benign enlargement of the prostate causing urinary problems. We compared the effects of various treatments on erectile function at time points up to 5 years after surgery. Compared to surgical removal of some of the prostate gland (transurethral resection of the prostate, TURP), a technique called prostatic urethral lift resulted in better erectile function scores at 24 months. However, other treatments did not differ in their effect on erectile function.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Meta-analysis with individual data of functional outcomes following Aquablation for lower urinary tract symptoms due to BPH in various prostate anatomies.

OBJECTIVES: To evaluate functional outcomes following Aquablation in various prostate volume and anatomical subgroups. DESIGN: A meta-analysis with individual patient data undergoing Aquablation therapy from four prospective, global, clinical studies that have been conducted with Aquablation; WATER, WATER II, FRANCAIS WATER and OPEN WATER. SETTING: Australia, Canada, Lebanon, Germany, New Zealand, UK and the USA. PARTICIPANTS: 425 men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with 1-year follow-up. INTERVENTIONS: Aquablation therapy is an ultrasound guided, robotically executed waterjet ablative procedure for the prostate. MAIN OUTCOME MEASURES: The analyses focus International Prostate Symptom Score (IPSS), uroflowmetry, postoperative Incontinence Severity Index (ISI) and surgical retreatment. RESULTS: 425 men with prostates ranging in size from 20 to 150 mL underwent Aquablation therapy. The outcomes from the seven questions in the IPSS questionnaire were grouped by the following; prostates <100 mL, prostates ≥100 mL, prostate anatomy with an obstructive median lobe identifed by imaging, and prostate anatomy without an obstructive median lobe. Regardless of subgroup, all outcomes are consistent and demonstrate a significant improvement from baseline. Specifically, improvements in frequency, urgency and nocturia demonstrated bladder function improvement. Patients entering treatment with severe incontinence, ISI score >4, and regardless of prostate size, showed a reduction in incontinence during patient follow-up. Surgical retreatment due to BPH symptoms occurred in 0.7% (95% CI 0.1%-2.0%). CONCLUSIONS: Across a variety of prostate anatomies, Aquablation therapy showed remarkable functional improvements following the index procedure. Additionally, men with moderate to severe LUTS/BPH and overactive bladder resulting in urge incontinence showed a reduction in incontinence symptoms postprocedure.