Predictors of achieving a minimal clinically important difference in lower urinary tract symptoms 3 months after Rezum therapy.

Introduction: Gaining insight into patient characteristics to predict the success of procedures is crucial for improving outcomes and for preoperative counselling. We identified predictors of achieving a minimal clinically important difference (MCID) in lower urinary tract symptoms (LUTS) 3 months after Rezum. Material and methods: A retrospective study was conducted on patients treated with Rezum. Patients with moderate or severe LUTS and a recorded International Prostate Symptom Score (IPSS) at 3 months were included and categorised into 2 cohorts based on experiencing a MCID at 3 months (≥ 25% improvement in IPSS). Predictors were identified through multivariate logistic regression analysis. Results: Out of 174 patients, 134 (77%) achieved a MCID at 3 months, and those who did had a higher median baseline IPSS (20 [16-26] vs 15 [10-21], P <0.001) and were more likely to have severe LUTS at baseline (53.0% vs 35.0%, P = 0.046) when compared to those who did not experience a MCID at 3 months. Higher baseline IPSS (OR: 1.10, 95% CI 1.04-1.17) and larger baseline prostate volumes (OR: 1.03, 95% CI 1.0-1.05) were predictors of achieving a MCID at 3 months. More specifically, a significantly greater proportion of patients with severe LUTS (83.5 vs 70.8%, P = 0.046) and prostate volume ≥60 cc (94.6 vs 71.4%, P = 0.003) achieved MCID at 3 months when compared to patients with moderate LUTS and prostate volumes <60 cc, respectively. Conclusions: More than three-quarters of patients treated with Rezum achieved a MCID at 3 months. Patients with severe LUTS and prostate volumes ≥ 60 cc may be optimal candidates for experiencing early relief in LUTS following Rezum.

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial.

BACKGROUND: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. METHODS: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. DISCUSSION: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

One-year outcomes after prostate artery embolization versus laser enucleation: A network meta-analysis.

Background: Although holmium laser enucleation (HoLEP) is considered a size-independent procedure for treatment of an enlarged prostate, prostate artery embolization (PAE) is emerging as an alternative modality to treat moderate and large benign prostatic hyperplasia. This study aims to compare the early post-operative and short-term efficacy of PAE and HoLEP. Methods: PubMed, Cochrane Library and EMBASE databases were searched. Network meta-analysis was performed following PRISMA-N-guidelines. Post-operative parameters analysed include international prostate symptom score (IPSS), quality of life (QOL), post-void residual urine (PVR), maximal uroflow rate (Qmax) and serious adverse events (SAE). Random effects model calculated weighted mean differences (WMD). If 95%CI crossed the line of no effect (WMD = 0), evidence indicated no statistically significant difference between treatments compared. Results: Qualitative and quantitative syntheses included 20 and 18 studies with 1991 and 1606 patients, respectively. At 3 months, there was no statistically significant difference between PAE and HoLEP in IPSS score improvement [WMD: -2.21: 95%CI: (-10.20, 5.78), favouring PAE], QoL score improvement [WMD: -0.22:95%CI: (-1.75, 1.32), favouring PAE] and PVR improvement [WMD: 26.97: 95%CI: (-59.53, 113.48), favouring HoLEP]. However, PAE was found inferior to HoLEP for Qmax improvement [WMD: 8.47, 95%CI: (2.89, 14.05), favouring HoLEP]. At 1-year follow-up, there was no statistically significant was found between PAE and HoLEP for IPSS score improvement [WMD:6.03, 95%CI: (-1.30, 13.35)], QoL score improvement [WMD: 0.03, 95%CI: (-1.19, 1.25)], PVR improvement [WMD:4.11, 95%CI: (-32.31, 40.53)] and Qmax improvement [WMD:2.60, 95%CI: (-2.20, 7.41)] with all differences favouring HoLEP. PAE was superior to HoLEP for SAE [PAE vs. HoLEP-OR: 0.68, 95%CI: (0.25, 1.37)]. Conclusion: HoLEP was superior to PAE at 3 months for Qmax improvement. There was no significant difference in IPSS, QoL, PVR and Qmax improvement at 1 year between PAE and HoLEP. PAE was also associated with lesser SAE compared to HoLEP. Studies on the long-term outcome of PAE are needed to establish the durability of early outcomes after PAE.

Minimally invasive techniques in quest of Holy Grail of surgical management of enlarged prostates: a narrative review.

PURPOSE: Past decade has seen a renewed interest in minimally invasive surgical techniques (MISTs) for management of enlarged prostate. This narrative review aims to explore newer MIST for benign prostatic hyperplasia (BPH) which are not yet integrated into established societal guidelines. METHODS: We conducted a literature search across PubMed, Google Scholar, and FDA ClinicalTrials.gov databases on June 1st, 2023, to identify studies published within the past decade exploring various MISTs for BPH. Additionally, we gathered insights from abstracts presented in meetings of professional associations and corporate websites. We broadly classified these procedures into three distinct categories: energy-based, balloon dilation, and implant/stent treatments. We collected detail information about the device, procedure details, its inclusion and exclusion criteria, and outcome. RESULTS: Our review reveals that newer energy-based MISTs include Transperineal Laser Ablation, Transurethral Ultrasound Ablation, and High-Intensity Focused Ultrasound. In the sphere of balloon dilation, Transurethral Columnar Balloon Dilation and the Optilume BPH Catheter System were gaining momentum. The noteworthy implants/stents that are on horizon include Butterfly Prostatic Retraction Device, Urocross Expander System, Zenflow Spring System, and ProVee Urethral Expander System. CONCLUSION: The exploration of various MISTs reflects ongoing efforts to enhance patient care and address limitations of existing treatments. This review provides a bird-eye view and valuable insights for urologists and researchers seeking to navigate the dynamic landscape of MISTs in the quest for effective and minimally invasive solutions for enlarged prostates.

Efficacy and safety of the Rezum system for the treatment of catheter-dependent urinary retention: Three-year real-world outcomes in a multimorbid, multiethnic population.

OBJECTIVES: To evaluate the long-term real-world efficacy and safety of Rezum for the treatment of catheter-dependent urinary retention in a multimorbid, multiethnic population. METHODS: A single-office, retrospective study was conducted on patients treated with Rezum between 2017 and 2019. Patients were included if they had catheter-dependent urinary retention prior to treatment and at least one follow-up within 36 months postoperatively. Patient demographics, procedural characteristics, adverse events (AEs), and outcome measures, including benign prostate hyperplasia (BPH) medication usage and postvoid residual (PVR), were collected at 3, 6, 12, and/or 36 months postoperatively. Regret was assessed at 36 months using the 5-item Decisional Regret Scale (DRS). RESULTS: A total of 27 patients met the inclusion criteria, with the majority being Asian (29.6%), followed by non-Hispanic Black (26.0%) and Hispanic (22.2%). Most patients (77.8%) had at least one comorbidity. Trial of void (TOV) was attempted at a median of 8 days (7, 13). Fourteen patients (51.9%) failed their initial TOV. Median time until catheter independence was 13.5 days (8.5, 28.8). Common AEs included urinary retention (51.9%), urinary tract infections (UTIs) (25.9%), and dysuria (25.9%). All cases of UTIs (7/7) and most cases of dysuria (6/7) occurred in patients who failed their initial TOV. At 36 months, there was a significant median percentage change in PVR (-100.0% [-100.0, -36.7], p = .049), and 40.4% of patients discontinued their BPH medications (p = .001). Of the 11 patients who filled out the DRS, 10 (90.9%) agreed/strongly agreed that they made the right decision. By 36 months, 4 patients (14.8%) underwent reoperation and 24 (88.9%) remained catheter-independent. CONCLUSIONS: At long-term follow-up, Rezum effectively treated catheter-dependent urinary retention with minimal decisional regret. In patients with urinary retention, urologists should consider delaying TOV until 2 weeks postoperatively to maximize the likelihood of a successful TOV and minimize the risk of AEs.

Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review.

PURPOSE: MAUDE database houses medical device reports of suspected device-related complications received by Food and Drug Administration. In the present study we aim to evaluate the MAUDE database for reported complications of MIST procedures. METHODS: The database was queried using keywords: rezum, urolift, prostate embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), prostate stent and Temporarily Implanted Nitinol Device (iTIND) on 10/1/22 to extract information regarding device problems and procedure-related complications. Gupta classification system was used to stratify complications. Statistical analysis was performed to compare frequency of complications among MIST procedures. RESULTS: We found a total of 692 reports (Rezum-358, urolift-226, PAE-53, TUNA-31, TUMT-19, prostatic stent-4, and iTIND-1). Most complications related to device or users were minor (level 1 and 2) and there was no significant difference among various MIST procedures. The screen/system error was responsible for 93% and 83% aborted cases in Rezum and TUNA, respectively, and PAE showed 40% of device component detachment/fracture. Overall Urolift and TUMT were associated with statistically significant higher incidence of major (level 3 and 4) complications (23% and 21%, respectively) as compared with Rezum (7%). Most major complications needing hospitalization after Urolift included hematoma and hematuria with clots and those after Rezum included urinary tract infection and sepsis. Thirteen deaths were reported, mostly due to cardiovascular events, which were classified as not associated with the proposed treatment. CONCLUSION: MIST for BPH can occasionally cause significant morbidity. Our data should assist urologists and patients in shared decision-making process.

Rezum water vapor therapy for patients with mild, moderate, or severe lower urinary tract symptoms: A retrospective study in a multiethnic population.

BACKGROUND: The Rezum System (Rezum) represents a novel, minimally invasive surgical therapy used to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). We evaluated the safety and efficacy of Rezum in patients with mild, moderate, or severe LUTS. METHODS: A single office, retrospective study was conducted on patients from a multiethnic population treated with Rezum between 2017 and 2019. Patients were categorized into three cohorts based on baseline International Prostate Symptom Score (IPSS) LUTS severity: mild LUTS (IPSS ≤ 7), moderate LUTS (IPSS 8-19), or severe LUTS (IPSS ≥ 20) cohorts. Outcome measures, including IPSS, quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), BPH medication usage, and adverse events (AEs) were collected and analyzed at baseline, 1-, 3-, 6-, and/or 12-months postoperatively. RESULTS: A total of 238 patients were included: 33 with mild LUTS, 109 with moderate LUTS, and 96 with severe LUTS. At 1-month follow-up, the moderate and severe LUTS cohorts saw significant improvements in IPSS (moderate LUTS: -3.0 [-6.0, 1.5], p < 0.001; severe LUTS: -10.0 [-16.0, -5.0], p < 0.001) and QoL (moderate LUTS: -1.0 [-3.0, 0.0], p < 0.001; severe LUTS: -1.0 [-3.0, 0.0], p < 0.001) and improvements remained durable up to 12-months (p < 0.001). The mild LUTS cohort saw significant worsening in IPSS by 2.0 (0.0, 12.0) at 1-month (p = 0.002) but returned to baseline at 3-months (p = 0.114). However, the mild LUTS cohort experienced significant improvements in QoL by -0.5 (-3.0, 0.0) at 3-months (p = 0.035) and nocturia by 0.0 (-1.0, 0.0) at 6-months (p = 0.002), both of which remained durable to 12-months (p < 0.05). Most AEs were transient and nonserious, with gross hematuria (66.5%) being most common. There were no significant differences in QoL point reduction, Qmax improvement, PVR reduction, and AE occurrence between the cohorts at 12-months (p > 0.05). At 12-months, 80.0%, 87.5%, and 66.0% of the patients in the mild, moderate, and severe LUTS cohorts discontinued their BPH medications, respectively. CONCLUSIONS: Rezum provides rapid and durable relief in LUTS in patients with moderate or severe LUTS and can be offered to patients with mild LUTS who have bothersome nocturia and wish to discontinue their BPH medications.

Patients' Perspectives on Attributes While Choosing Minimally Invasive Surgery for Benign Prostatic Hyperplasia Procedures: Experience from Men Undergoing Water Vapor Thermal Therapy.

Objective: To understand which attributes men with benign prostatic hyperplasia (BPH) undergoing water vapor thermal therapy (WVTT) find important while considering treatment options for the condition. Methods: Men (n = 170) with lower urinary tract symptoms due to BPH who underwent WVTT between April 2019 and November 2020 in a Toronto urologic clinic were invited to participate in an online survey. The survey included eight attributes of BPH surgical procedures and five attributes of WVTT. Patients were asked how important each attribute was to them before they selected a BPH procedure and decided to undergo WVTT. Results: In total, 128 respondents (75%) completed the survey. A majority of the respondents were White (88%), married (83%), and aged 60-69 years old (45%). Approximately 97% of respondents rated the ability to avoid further BPH treatments as "very important" or "extremely important," followed by duration to return to normal activities (79%), and wait times to receive the procedure (57%). Only 47% of patients reported that postprocedural catheterization was important. For WVTT, 98% of the respondents rated avoiding more invasive surgical treatments and 88% rated a quick recovery as important attributes. Conclusions: Among men with moderate-to-severe BPH undergoing WVTT, the most important attributes for selecting a BPH surgical procedure were avoiding further BPH treatments, returning quickly to normal activities, and reducing treatment wait times. Most men chose WVTT to avoid more invasive procedures and have a quick recovery.

The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate.

INTRODUCTION: The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms. We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life. MATERIALS AND METHODS: We included 64 men, treated for benign prostate hyperplasia for at least 1 year. All patients had Qmax≤ 13 mL/s and IPSS >12. Insertion of the device was performed via cystoscopy. Follow-up visits were performed at 2 weeks, 1, 3, 6, and 12 months and included uroflowmetry, IPSS, QoL, and sexual function questionnaires. Cystoscopy was performed on 3 and 12 months. RESULTS: Patients age was 50-83 years. 28 patients completed a 1-year follow-up with an intact device. Mean Qmax improved by 2 mL/s (25%), IPSS median drop was 10 points (40%), and QoL score was 1.5 points (38%). Sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the devices with urethral mucosa was observed. In 1 patient, the device was repositioned. In 19 patients, the device was removed. 12 patients returned to alpha-blocker therapy and 7 patients underwent TURP. One patient developed a bulbar urethral stricture. CONCLUSIONS: We demonstrated feasibility and good tolerability of the Butterfly device.

Transurethral Vapor Ablation in Patients with Intermediate-Risk Localized Prostate Cancer.

Purpose: We report results of a prospective, multicenter single-arm study of transurethral vapor ablation (TUVA) of prostate tissue in patients with unilateral, intermediate-risk, localized prostate cancer (PCa). Materials and Methods: Men ≥45 years of age with biopsy-confirmed unilateral Gleason grade group 2 (GGG2) adenocarcinoma of the prostate, prostate volume of 20-80 cc, and prostate-specific antigen (PSA) ≤15 ng/mL were enrolled. Cystoscopy and transrectal ultrasound (TRUS) guidance were used to deliver ∼103°C water vapor to prostate zones for unilateral hemigland ablation, including destruction of cancers detected by multiparametric MRI (mpMRI) and confirmed by biopsy. The primary outcomes were device-related serious adverse events (SAEs). At 7 days and 6 months postprocedure, the ablation extent was assessed by mpMRI; MRI/TRUS fusion biopsies were completed at 6 months. Quality of life (QOL) was assessed with validated questionnaires. Results: All subjects underwent a single hemigland TUVA procedure. No SAEs occurred. Grade 2 procedure-related AEs included transient urinary retention (n = 4) and erectile (n = 1) or ejaculatory dysfunction (n = 1). At 7 days, mpMRI revealed complete ablation of 14/17 (82%) visible lesions. At 6 months, biopsies showed no Gleason pattern ≥4 or ≥GGG2 cancer on the treated side of prostates in 13/15 (87%) subjects. Ten of 15 (67%) subjects were biopsy negative. Of the 5 biopsy-negative subjects, 2 had one core each of 3 + 4 disease and 3 had one core each of 3 + 3 disease with ≤5% involvement. Median prostate volume was reduced by 40.7% and PSA by 58%. Extensive QOL assessments showed, on average, no appreciable negative effects of treatment. Conclusions: Initial evidence suggests that TUVA is safe in men with intermediate-risk PCa. Preliminary results demonstrate the absence of ≥GGG2 disease on the treated side in 87% of men and a favorable QOL profile.

Rezum Outcomes in Relationship to Number of Injections: Is Less More?

Objectives: To assess efficacy and safety outcomes in relationship to the number of injections given during Rezum treatment. Methods: A retrospective study was conducted on patients with moderate to severe lower urinary tract symptoms (LUTS) treated with Rezum. Patients were stratified into cohorts based on the number of injections received per lateral prostatic lobe: 1, 2, 3, or 4 injections. International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), International Index of Erectile Function (IIEF)-Erectile Function, IIEF-Orgasmic Function, and adverse events were collected at baseline, 1, 3, 6, and/or 12 months postoperatively. Results: A total of 179 patients were included: 58, 91, 22, and 8 patients in the 1, 2, 3, and 4 injections cohorts, respectively. Baseline demographics significantly different across cohorts were age, history of urinary retention, prostate-specific antigen, prostate volume, prostatic urethral length, and presence of median lobe. At 3 months, all cohorts reported significant improvements in IPSS and QoL, which remained durable to 12 months. There were no significant differences in changes in IPSS, QoL, PVR, and IIEF-Erectile and Orgasmic Function between the cohorts at any follow-up. Multiple linear regression showed that the number of injections did not predict changes in IPSS, QoL, PVR, and IIEF-Erectile and Orgasmic Function at any follow-up (p > 0.05) but predicted change in Qmax at 3 months (ß = 5.7, p = 0.019). Multiple logistic regression showed that for each additional injection, the odds of gross hematuria, penile burning, penile pain, and dysuria increased by 3.8, 2.6, 2.2, and 3.0, respectively. Conclusions: Utilizing less injections represents a safe treatment strategy without compromising Rezum's efficacy in providing durable relief in LUTS.

Risk Factors and Real-World Short-Term Outcomes of a Failed Trial of Void After Rezum Therapy in a Multiethnic Population.

Background: Postoperative urinary retention is a common complication following surgery for benign prostatic hyperplasia. We aimed to identify risk factors for a failed trial of void (TOV) following treatment with the Rezum system and assess the impact of a failed TOV on short-term outcomes. Methods: A single-office retrospective study was conducted on patients treated with Rezum therapy between 2017 and 2019. A urinary catheter was placed in all patients following Rezum therapy. Demographic data and outcome measures, including the International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), and adverse events, were analyzed at baseline and 1, 3, and/or 6 months postoperatively. Risk factors were identified through multivariate logistic regression analysis. Results: A total of 289 patients were included. Thirty-five patients (12.1%) failed a TOV, while 254 (87.9%) had an effective TOV. All patients were given a TOV after a median of 5 days (4-5). Those who failed the TOV spent an additional mean of 13.7 ± 13.3 days with a catheter. Patients who failed the TOV were more likely to get a urinary tract infection compared with those who had an effective TOV (20.0% vs 4.7%, p < 0.001). All patients experienced significant improvements in IPSS, QoL, and Qmax at 1, 3, and/or 6 months. On multivariate analysis, a high baseline PVR was the only independent predictor of a failed TOV (odds ratio: 1.01, 95% confidence interval 1.00-1.01). A greater proportion of patients with a baseline PVR >200 mL failed the TOV (40.0%) compared with patients with a baseline PVR <200 mL (10.9%, p = 0.008). Conclusions: Approximately one in eight patients failed the TOV following Rezum therapy. Baseline PVR was the only independent risk factor for a failed TOV. Nevertheless, all patients experienced significant relief of urinary symptoms. Patients with high baseline PVR, particularly >200 mL, may require a catheter for an extended duration.

Prostatic Urethral Lift for Obstructive Median Lobes: Consistent Results Across Controlled Trial and Real-World Settings.

Introduction: The evidence for prostatic urethral lift (PUL), in treating lower urinary tract symptoms/benign prostatic hyperplasia (BPH) in men with obstructive median lobes (OMLs), has grown. In this study, we present the first detailed comparison of outcomes between OML patients treated with PUL in controlled and real-world settings to relevant comparators (subjects treated with transurethral resection of the prostate [TURP] and sham in randomized controlled trials [RCTs]) to demonstrate similar symptom, safety, and patient experience outcomes. Materials and Methods: Symptom and safety outcomes and patient satisfaction were compared through 12 months among controlled PUL studies: BPH6 RCT (35 men randomized to TURP); L.I.F.T. pivotal RCT in subjects with lateral lobe obstruction (66 subjects randomized to sham) and MedLift, an U.S. Food and Drug Administration-approved Investigational Device Exemption (IDE) extension of the L.I.F.T. trial (45 men with OML). Symptom improvement, catheterization, and adverse event rates were compared between MedLift subjects and OML patients (n = 187) from the large real-world retrospective (RWR) study of PUL filtered on baseline characteristics to approximate the MedLift population. Results: Posttreatment, International Prostate Symptoms Score (IPSS) improvement for MedLift subjects was 170% greater compared with sham at 3 months with significantly better quality of life (QoL), Qmax, and benign prostatic hyperplasia impact index (BPHII). Compared with TURP, MedLift IPSS and QoL improved significantly better at 1 and 3 months and with superior ejaculatory function scores at all time points after PUL. IPSS, QoL, postvoid residual (PVR), and Qmax outcomes were equivalent between MedLift and RWR OML groups at 3, 6, and 12 months. RWR OML patients did not experience higher rates of overall adverse events compared with MedLift. Conclusion: Controlled and real-world outcomes confirm PUL is a safe and effective treatment for BPH patients with and without OML.

Trends in minimally invasive surgical therapies for overactive bladder management in Australia.

OBJECTIVE: To evaluate the national trends in minimally invasive surgical therapies (MIST) for overactive bladder (OAB) in Australia over the past decade. METHODS: Annual MIST data were extracted using the Australian Medicare Benefit Schedule (MBS) on intravesical botulinum toxin (BTX), sacral nerve modulators (SNM) and percutaneous tibial nerve stimulators (PTNS) performed between 2010 and 2021. Population-adjusted rates of these procedures were compared in relation to individual states and against the introduction of various OAB drugs during the intervening years. RESULTS: The overall national utilization of MIST for OAB has increased over the last decade. The data reflect a rapid uptake in PTNS over the last 2 years following its introduction compared to the relatively steady increase in BTX and SNM over the past decade. There was minimal difference in SNM lead and generator placement, suggesting perhaps the conversion of trial SNM to permanent SNM has been relatively stable across the years. In contrast, there was an increase in PTNS maintenance in the following years following the initial rise in the PTNS treatment initiation. The introduction of various OAB drugs in the market did not seem to significantly affect the pattern of MIST uptake. CONCLUSION: Despite the introduction of various OAB drugs, the overall MIST has increased steadily over the last decade, especially with PTNS. Further exploration into the motivators for specific MIST and cost-benefit analysis of these MIST for OAB is warranted.

New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia.

INTRODUCTION: Lower urinary tract symptoms (LUTS) from bladder outlet obstruction from benign prostatic hyperplasia (BPH) occur in a large percentage of urologic patients. Treatment of this condition with medical and surgical therapy provides symptom relief but has serious adverse effects and causes sexual dysfunction. New technologies to treat BPH-associated LUTS aim to effectively treat urinary symptoms and minimize side effects and sexual dysfunction. AIM: To review the efficacy of new and emerging therapies for treatment of LUTS from BPH. METHODS: A literature search was performed to identify therapies for LUTS from BPH with early outcomes data within the past 5 years. MAIN OUTCOME MEASURES: Improvement in International Prostate Symptom Score (IPSS) and effect on sexual functions such as erectile and ejaculatory functions as measured on the International Index of Erectile Function and the Male Sexual Health Questionnaire. RESULTS: Technologies introduced within the past 5 years include techniques using intraprostatic injectables, mechanical devices, and prostatic tissue ablation. Most technologies remain in the development phase and have only phase I and II studies available that show promising alleviation of urinary symptoms. Injectables have not typically surpassed placebo or sham effects, although special cohorts could be exceptions. Thus far, convective water vapor ablation therapy and prostatic urethral lift have shown the most promise, with short- and medium-term data available on phase III studies demonstrating significant improvement in IPSS with minimal impact on sexual function. Many of these technologies are limited in their potential treatment population by prostate size and conformation, whereas other therapies might be more generalizable. CONCLUSION: Many new technologies aim to treat LUTS from BPH and minimize sexual side effects. Most therapies remain experimental, although prostatic urethral lift and water vapor ablation therapy have been brought to market and show promise. Long-term durability of symptom relief remains to be demonstrated. Gupta NK, Gange SN, McVary KT. New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia. Sex Med Rev 2018;7:491-498.

Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years.

INTRODUCTION: Successful outcomes have been reported for the treatment of lower urinary tract symptoms (LUTS) with the prostatic urethral lift (PUL) in a number of clinical investigations. Our aim was to investigate PUL outcomes in patients treated in a day-to-day clinical setting without the rigid exclusion criteria of clinical studies. MATERIALS AND METHODS: We investigated the outcome of the PUL procedure at five German departments during the initial period when PUL was approved for the clinic (10/2012-06/2014). All candidates for transurethral resection of the prostate (TURP) received PUL information and were given the choice of procedures. The only exclusion criterion was an obstructive median lobe. No patients were excluded because of high post-void residual volume (PVR), prostate size, retention history or LUTS oral therapy. Maximum urinary flow (Qmax), PVR, International Prostate Symptom Score (IPSS) and Quality of Life (QOL) were assessed at baseline, 1, 6, 12, and 24 months after surgery. RESULTS: Of 212 TURP candidates, 86 choose PUL. A mean of 3.8 (2-7) UroLift implants were implanted in patients of 38-85 years with a prostate size of 17-111 ml over 57 (42-90) min under general or local anesthesia. Thirty-eight (38.4%) patients had severe BPH obstruction and would have been denied PUL utilizing previously reported study criteria. Within 1 month 74 (86%) reported substantial symptom relief with significant improvements in Qmax, PVR, IPSS, and QOL (p < 0.001) that was maintained within the follow-up. Sexual function including ejaculation was unchanged or improved. No Clavien-Dindo Grad ≥ 2 was reported postoperatively. Eleven (12.8%) patients were retreated over 2 years. Twelve (86%) of 14 patients presenting with chronic urinary retention were catheter free at last follow-up. CONCLUSION: PUL is a promising surgical technique that may alleviate LUTS, even in patients with severe obstruction.

24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham.

OBJECTIVE: To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. PATIENTS AND METHODS: In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3 months after the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. RESULTS: At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P < 0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. CONCLUSIONS: The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.

Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systematic review and meta-analysis.

CONTEXT: Treatment for lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH) is varied, and significant side effects, particularly concerning sexual function, affect uptake. The prostatic urethral lift (PUL) procedure is a recent addition to the armamentarium for BPH treatment, with independent reports suggesting improvement of symptoms, sexual function, and urinary flow. OBJECTIVE: We undertook a systematic review and meta-analysis of reported symptomatic, functional, and sexual outcomes following the PUL procedure. EVIDENCE ACQUISITION: We performed a critical review of Medline, Embase, ScienceDirect, Cochrane Library, and Web of Science databases in May 2014 according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Quality assessment was performed using a modification of the Methodological Index for Non-Randomized Studies tool. All retrospective, prospective, and controlled trials were included for analysis. Symptom scores, sexual health scores, and functional outcomes were pooled and meta-analysed using quality and random-effects models. EVIDENCE SYNTHESIS: Ten articles comprising six independent patient cohorts were included for analysis. Pooled estimates from between 452 and 680 patients suggested overall improvement following PUL, including symptoms (large gain; standardised mean gain range of 1.3-1.6, International Prostate Symptom Score difference of -7.2 to -8.7 points), maximum flow rate (3.8-4.0 ml/s), and quality of life (2.2-2.4 points). Sexual function was preserved with a small improvement estimated at 12 mo (standardised mean gain range of 0.3-0.4). Pooled estimates were mostly heterogeneous across study groups. CONCLUSIONS: PUL is a well-tolerated, minimally invasive therapy for BPH that provides favourable symptom, sexual health, and functional outcomes during follow-up to 12 mo. Longer follow-up and larger randomised studies are required to further confirm these preliminary results. PATIENT SUMMARY: We reviewed the early results of an innovative procedure directed towards the management of prostate enlargement. The results revealed a well-tolerated procedure that produces improvement in urinary symptoms and function while preserving sexual function.