Improvement In International Prostate Symptom Score Research Articles

Comparison Between Thulium Fiber Laser and High-power Holmium Laser for Anatomic Endoscopic Enucleation of the Prostate: A Propensity Score–matched Analysis from the REAP Registry

BackgroundDifferent lasers have been developed for treatment of benign prostatic hyperplasia, with no definitively superior technique identified to date. ObjectiveTo compare surgical and functional enucleation outcomes in real-world multicentre practice using high-power holmium laser (HP-HoLEP) and thulium fiber laser enucleation of the prostate (ThuFLEP) for different prostate sizes. Design, setting, and participantsThe study included 4216 patients who underwent HP-HoLEP or ThuFLEP at eight centers in seven countries between 2020 and 2022. Exclusion criteria were previous urethral or prostatic surgery, radiotherapy, or concomitant surgery. Outcome measurements and statistical analysisTo adjust for the bias arising from different characteristics at baseline, propensity score matching (PSM) was used to identify 563 matched patients in each cohort. Outcomes included the incidence of postoperative incontinence, early complications (30-d), and delayed complications, and results for the International Prostate Symptom Score (IPSS), quality of life (QoL), maximum flow rate (Qmax), and postvoid residual volume (PVR). Results and limitationsAfter PSM, 563 patients in each arm were included. Total operative time was similar between the arms, but enucleation and morcellation times were significantly longer for ThuFLEP. The rate of postoperative acute urinary retention was higher in the ThuFLEP arm (3.6% vs 0.9%; p = 0.005), but the 30-d readmission rate was higher in the HP-HoLEP arm (22% vs 8%; p = 0.016). There was no difference in postoperative incontinence rates (HP-HoLEP:19.7%, ThuFLEP:16.0%; p = 0.120). Rates of other early and delayed complications were low and comparable between the arms. The ThuFLEP group had higher Qmax (p < 0.001) and lower PVR (p < 0.001) than the HP-HoLEP group at 1-yr follow-up. The study is limited by its retrospective nature. ConclusionsThis real-world study shows that early and delayed outcomes of enucleation with ThuFLEP are comparable to those with HP-HoLEP, with similar improvements in micturition parameters and IPSS. Patient summaryAs lasers become readily available for the treatment of enlarged prostates causing urinary bother, urologists should focus on performing good anatomic removal of prostate tissue, with the choice of laser not as important for good outcomes. Patients should be counseled about long-term complications, even when the procedure is being performed by an experienced surgeon.

Three years outcomes of transperineal laser ablation of the prostate.

Ultra-minimally Invasive Surgical Techniques (uMISTs) play an increasingly significant role in treating benign prostatic obstruction (BPO) as an alternative to both medical therapy and surgery. Transperineal laser ablation of the prostate (TPLA) is an uMIST that has shown its efficacy in symptom relief and improvement of urodynamic parameters while sparing ejaculatory function and having a low risk of complications. This is the 3-year follow-up of a pilot study on TPLA. TPLA was performed using the SoracteLite™ system. It consists of ablating prostate tissue through a diode laser, eventually causing prostate volume reduction. We recorded International Prostate Symptom Score (IPSS), uroflowmetry parameters, the Male Sexual Health Questionnaire (MSHQ-EjD), and prostate volume at baseline and after 3 years. The Wilcoxon Test was employed to compare continuous variables. Twenty men completed a 3-year follow-up after TPLA. The median prostate volume was 41.5 mL (IQR: 40.0-54.3). Preoperative median IPSS, Q<inf>max</inf>, and MSHQ-EjD were 18 (IQR: 16-21), 8.8 mL/s (IQR: 7.8-10.8), and 4 (IQR: 3-8). TPLA showed significant improvement in IPSS (-37.2%; P<0.01) and Q<inf>max</inf> (45.8%; P<0.01); median MSHQ-EjD improvement was by 60% (P<0.01) and median prostate volume reduction was by -20.4% (P<0.01). This analysis shows that TPLA maintains satisfactory results within 3 years. Therefore, TPLA confirms its role in the treatment of patients unsatisfied or intolerant to oral therapies but not eligible for surgery to avoid impact on sexual function or due to anesthesiologic contraindications.

(146) Rezum Water Vapor Therapy for Patients with Mild, Moderate, or Severe Lower Urinary Tract Symptoms: A Retrospective Study in a Multiethnic Population

Abstract Introduction Benign prostatic hyperplasia (BPH) is a common chronic condition that is associated with the development of lower urinary tract symptoms (LUTS). Symptom severity of LUTS secondary to BPH can range from mild, moderate, to severe and can be assessed utilizing the International Prostate Symptom Score (IPSS). The Rezum System (Rezum; Boston Scientific, Marlborough, MA, USA) is a minimally invasive surgical therapy that utilizes convective radiofrequency water vapor thermal energy to ablate obstructive lobes of the prostate, resulting in cell necrosis and improvement in LUTS. Objective To evaluate the safety and efficacy of Rezum in patients with mild, moderate, or severe LUTS secondary to BPH. 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 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), alpha blockers and 5-alpha reductase inhibitors 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&amp;lt;0.001; severe LUTS: -10.0 [-16.0, -5.0], p&amp;lt;0.001) and QoL (moderate LUTS: -1.0 [-3.0, 0.0], p&amp;lt;0.001; severe LUTS: -1.0 [-3.0, 0.0], p&amp;lt;0.001) and improvements remained durable up to 12-months (p&amp;lt;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&amp;lt;0.05). Most AEs were transient and non-serious, 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&amp;gt;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. Disclosure No

MP79-16 ANALYSIS OF THE EFFECT OF TESTOSTERONE REPLACEMENT ON BODY COMPOSITION, PHYSICAL FITNESS AND THE CORRELATION WITH HYPOGONADAL SYMPTOMS IN THE TESTOSTERONE DEFICIENCY

You have accessJournal of UrologyCME1 Apr 2023MP79-16 ANALYSIS OF THE EFFECT OF TESTOSTERONE REPLACEMENT ON BODY COMPOSITION, PHYSICAL FITNESS AND THE CORRELATION WITH HYPOGONADAL SYMPTOMS IN THE TESTOSTERONE DEFICIENCY Tae Yong Park, Dong Su Kim, Jeong Kyun Yeo, and Min Gu Park Tae Yong ParkTae Yong Park More articles by this author , Dong Su KimDong Su Kim More articles by this author , Jeong Kyun YeoJeong Kyun Yeo More articles by this author , and Min Gu ParkMin Gu Park More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: This study aimed to investigate how testosterone replacement therapy (TRT) change body composition and physical fitness, and which those changes correlate with serum testosterone level and hypogonadal symptoms. METHODS: Seventy patients with testosterone deficiency (TD) were divided into group I (n: 23) and group II (n :47). Only group II was given testosterone enanthate intramuscularly for 6 months. Both groups were investigated following items at the beginning and end of the study: Baseline demographics and serologic test; questionnaires of aging male symptom (AMS) scale and international prostate symptom score (IPSS); BMI, waist circumference, body composition; and physical fitness. Body composition was assessed by bioelectrical impedance analysis. Seven types of basic exercise tests were used to measure physical fitness. RESULTS: No significant difference was observed in baseline measurements between the two groups before treatment. After 6 months, group I showed no significant change in all measurements. Group II showed significant improvement in IPSS and AMS scales. Hematocrit, and prostate specific antigen slightly increased, while total cholesterol significantly decreased after treatment. As to body composition parameters, TRT significantly decreased body fat mass, visceral fat mass and waist circumference. Skeletal muscle mass was significantly increased by TRT although upper body muscle appeared to be more responsive. Most parameters of physical fitness resulted in improvement except for flexibility and endurance. The decrease of waist circumference was significantly correlated with serum testosterone level changes. AMS scale improvement was correlated with the changes of IPSS, cardiorespiratory fitness and agility. CONCLUSIONS: TRT improved hypogonadal and lower urinary tract symptoms. TRT also resulted in overall improvement in metabolic syndrome components, body composition and physical fitness. Testosterone increment and hypogonadal symptom improvement are correlated with waist circumference, cardiorespiratory fitness, and agility, respectively. Combined adjunctive exercise program that improve those parameters, might maximize the effect of TRT. Source of Funding: No conflict of interests © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1147 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tae Yong Park More articles by this author Dong Su Kim More articles by this author Jeong Kyun Yeo More articles by this author Min Gu Park More articles by this author Expand All Advertisement PDF downloadLoading ...

PD41-02 12-MONTH OUTCOMES FROM THE FIRST NORTH AMERICAN STUDY OF THE ZENFLOW SPRING SYSTEM FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)

You have accessJournal of UrologyCME1 Apr 2023PD41-02 12-MONTH OUTCOMES FROM THE FIRST NORTH AMERICAN STUDY OF THE ZENFLOW SPRING SYSTEM FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Dean Elterman, Edward D. Matsumoto, and Kevin C. Zorn Dean EltermanDean Elterman More articles by this author , Edward D. MatsumotoEdward D. Matsumoto More articles by this author , and Kevin C. ZornKevin C. Zorn More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The ZEST-CAN study is a prospective single-arm study evaluating the Zenflow Spring System for BPH. The Zenflow Spring System is a novel minimally invasive surgical therapy (MIST) that delivers an appropriately sized nitinol stent-like device into the prostatic urethra displacing the lateral lobes for improved urinary flow. METHODS: Ten (10) subjects received the device at 3 centers in Canada. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and IPSS-QOL, and functional improvement was measured by peak urinary flow rate (Qmax). Erectile and ejaculatory function were evaluated utilizing validated questionnaires. The clinical events committee independently adjudicated any adverse event. RESULTS: Subjects treated with the Zenflow Spring showed a significant reduction in IPSS from baseline to 12 months (21.2 vs 11.4, p<0.01), representing a 47% reduction in IPSS. IPSS QOL significantly improved from baseline to 12 months (5.4 vs 2.4, p<0.010, representing a 56% improvement. Qmax improved from 9.7 mL/sec at baseline to 14.0 mL/sec after treatment (p<0.05) representing a 45% improvement. There were no changes in sexual or ejaculatory function as assessed by the validated questionnaires. The responder rate at 12 months calculated as those with 30% improvement in IPSS was 70%. (7/10 subjects). Adverse events post procedure were typically mild and transient and common to events reported in similar procedures. CONCLUSIONS: The Zenflow Spring System resulted in immediate and significant symptomatic improvements from 3 through 12 months. Subjects experienced improvements in symptoms, quality of life, maximum flow rate without any sexual dysfunction through 12 months of follow up. These results are currently being validated through a large, multiple centers, prospective randomized study in the United States and Canada. Source of Funding: Zenflow Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1058 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Dean Elterman More articles by this author Edward D. Matsumoto More articles by this author Kevin C. Zorn More articles by this author Expand All Advertisement PDF downloadLoading ...

PD41-03 12-MONTH OUTCOMES FROM A RANDOMIZED, SHAM CONTROLLED STUDY EVALUATING A NOVEL DRUG COATED BALLOON FOR THE TREATMENT OF BPH

You have accessJournal of UrologyCME1 Apr 2023PD41-03 12-MONTH OUTCOMES FROM A RANDOMIZED, SHAM CONTROLLED STUDY EVALUATING A NOVEL DRUG COATED BALLOON FOR THE TREATMENT OF BPH Steven A. Kaplan, Jared Moss, Sheldon Freedman, Karl Coutinho, Ning Wu, Mitchell Efros, Dean Elterman, Richard D'Anna, Osvaldo Padron, Kaiser J. Robertson, Samuel Lawindy, Sandeep Mistry, Neal Shore, Jeffrey Spier, Jed Kaminestky, Brian Mazzarella, David Cahn, Mark Jalkut, and Alexis Te Steven A. KaplanSteven A. Kaplan More articles by this author , Jared MossJared Moss More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Karl CoutinhoKarl Coutinho More articles by this author , Ning WuNing Wu More articles by this author , Mitchell EfrosMitchell Efros More articles by this author , Dean EltermanDean Elterman More articles by this author , Richard D'AnnaRichard D'Anna More articles by this author , Osvaldo PadronOsvaldo Padron More articles by this author , Kaiser J. RobertsonKaiser J. Robertson More articles by this author , Samuel LawindySamuel Lawindy More articles by this author , Sandeep MistrySandeep Mistry More articles by this author , Neal ShoreNeal Shore More articles by this author , Jeffrey SpierJeffrey Spier More articles by this author , Jed KaminestkyJed Kaminestky More articles by this author , Brian MazzarellaBrian Mazzarella More articles by this author , David CahnDavid Cahn More articles by this author , Mark JalkutMark Jalkut More articles by this author , and Alexis TeAlexis Te More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel minimally invasive surgical therapy (MIST) that combines mechanical dilation with the delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing. METHODS: 148 subjects were randomized in a 2:1 fashion at 18 centers in the US and Canada. Subjects and evaluating personnel were blinded to treatment through 12-months. 12-month follow-up is complete. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS) and BPH Impact Index (BPH-II), functional improvement measured by peak urinary flow rate (Qmax) and post-void residual volume (PVR). Erectile and ejaculatory function were evaluated utilizing validated questionnaires. Adverse events were prospectively collected and relatedness to treatment was adjudicated by an independent, blinded clinical events committee. RESULTS: Subjects treated with Optilume BPH showed a significant reduction in IPSS through 12 months (23.4 vs 10.9, p<0.001). Improvement in IPSS at 12 months was significantly greater for Optilume BPH compared to Sham in the intent-to-treat population (11.5 vs 4.8, p<0.001). Qmax more than doubled from 8.9 mL/sec at baseline to 19.0 mL/sec after treatment with Optilume BPH, while average PVR decreased from 84 mL to 58 mL (p=0.004). There were no changes in perceived sexual or ejaculatory function. The most reported treatment related adverse events after treatment with Optilume BPH included hematuria (39/98 [39.8%]), urinary tract infection (11/98 [11.2%]), and dysuria (8/98 [8.2%]). CONCLUSIONS: Treatment with Optilume BPH resulted in significant, immediate symptomatic and functional improvements and to date the highest Qmax reported in BPH MIST trials. Durability of these outcomes was shown through 12 months follow-up, demonstrating the intended effect of an immediate mechanical benefit that is sustained long-term by the delivery of paclitaxel. Long-term outcomes will be verified with 5 year follow-up for Optilume BPH. Source of Funding: Urotronic, Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1059 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven A. Kaplan More articles by this author Jared Moss More articles by this author Sheldon Freedman More articles by this author Karl Coutinho More articles by this author Ning Wu More articles by this author Mitchell Efros More articles by this author Dean Elterman More articles by this author Richard D'Anna More articles by this author Osvaldo Padron More articles by this author Kaiser J. Robertson More articles by this author Samuel Lawindy More articles by this author Sandeep Mistry More articles by this author Neal Shore More articles by this author Jeffrey Spier More articles by this author Jed Kaminestky More articles by this author Brian Mazzarella More articles by this author David Cahn More articles by this author Mark Jalkut More articles by this author Alexis Te More articles by this author Expand All Advertisement PDF downloadLoading ...

Robot-assisted simple prostatectomy for prostates greater than 100 g

Efforts are ongoing to treat severe benign prostatic hyperplasia as traditional endoscopic treatment options are often difficult to perform and associated with significant complications. This manuscript highlights our initial experience of robot-assisted simple prostatectomy [RASP] with minimum a year follow-up. We also compared our outcomes with published literature. After an Institution Review Board approval, we gathered data of 50 cases of RASP between Jan 2014 and May 2021. Patients with prostate volume > 100cc [calculated from magnetic resonance imaging (MRI)] and prostate biopsy confirmed benign prostate were candidates for RASP. Patients underwent RASP via transperitoneal route either by suprapubic or trans-vesical approach. Preoperative demographics, peri-operative parameters and post-operative parameters such as hospital stay, catheter removal, urinary continence and uroflow were recorded in standard database and presented as descriptive statistics. Patients presented with a baseline median International Prostate Symptom Score (IPSS) of 23 (inter-quartile range (IQR) 21,25) and a median PSA of 7.7ng/ml (IQR 6.4,8.7). Median preoperative prostate volume was 167ml (IQR, 136,198ml). Median console time was 118min, and median estimated blood loss was 148ml (IQR 130, 167ml). None of our cohort needed intraoperative transfusion, conversion to open surgery or developed any complications. Median time to Foley removal was 10days (IQR 8,12). Significant drop in the IPSS score and improvement in Qmax was noted over the period of follow-up. RASP is associated with considerable improvements in urinary symptoms. However, comparative studies with endoscopic treatment options of large prostatic adenomas are warranted and ideally include cost analysis of different procedures.

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

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. 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. 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. 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.

Chronic prostatic inflammation as a prognostic marker for post-operative improvement in clinical parameters after transurethral resection of prostate

Background: Medical therapy of prostatic symptoms and reduce study on benign prostatic hyperplasia (BPH) recently demonstrated a link between histological prostatic inflammation and prostate enlargement or symptoms scores. Aims and Objectives: Prognostication of symptoms of lower urinary tract based on pathological diagnosis following transurethral resection of prostate (TURP). Materials and Methods: This was a prospective observational study. A total of 60 BPH patients who underwent TURP were studied; 30 patients in each group, BPH without inflammation (Group I), and BPH with inflammation (Group II). Pre-operative and post-operative international prostate symptom score (IPSS), overactive bladder symptom score (OABSS), and uroflowmetry were compared in both groups. Chronic prostatic inflammation was assessed by the grade (lymphocyte density), extent (lymphocyte distribution), and location of inflammation. Results: The prostate volume was significantly higher in Group II as compared to Group I (53.2±1.29 vs. 50.87±1.48). The improvement in IPSS and OABSS in each group, before and after surgery, was significant but the between-group difference was not significant. The post-operative voided volume (in ml) in Group I was 273.27±52.34 and in Group II, it was 289.47±34.25 (P=0.03). The post-operative post-void residual volume (in ml) was 21.97±2.55 in Group I and 13.28±2.11 in Group II (P=0.017). The post-operative Qmax (ml/s) in Group I was 15.41±2.1 and in Group II it was 19.28±2.11. (P=0.041). Conclusion: Surgical resection of the prostate helps in a higher degree of improvement in post-operative clinical parameters in BPH patients with inflammation.

OP19 Comparative Effectiveness Of Common Treatment Options For Benign Prostatic Hyperplasia: A Systematic Review And Network Meta-Analysis

IntroductionTreatment options for men with moderate-to-severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) include medical therapy, minimally invasive surgical therapies (MISTs), and invasive surgical procedures. While these treatments are recommended by American Urological Association Guidelines, they have different clinical profiles impacting both efficacy and durability outcomes. Using an indirect comparison approach, this study assessed the clinical effects of combination therapy (CT) using alpha-blockers and 5-alpha reductase inhibitors, two emerging MISTs (prostatic urethral lift [PUL] and water vapor thermal therapy [WVTT]), and two invasive surgical procedures (photoselective vaporization of the prostate [PVP] and transurethral resection of the prostate [TURP]).MethodsA systematic search of Medline, Embase, Cochrane Library, and relevant health technology assessment (HTA) databases was conducted to identify randomized and non-randomized clinical trials of the five treatments published prior to December 2020. Trials were included if they reported changes in International Prostate Symptom Score (IPSS) and retreatment rates, without any country or language restrictions. A random-effects network meta-analysis (NMA) with an aggregate regression model was performed to account for the baseline BPH severity and characteristic differences among men from the different trials.ResultsA total of 237 of 3,104 retrieved abstracts were included for full-text review. Of these, 16 randomized and four non-randomized clinical trials were included in the NMA. The random-effects NMA showed among medical and minimally invasive therapies, WVTT had the greatest one-year IPSS improvement (-∆11.7), followed by PUL (-∆10.4) and CT (-∆10.3). The one-year IPSS improvement for TURP and PVP was comparable (-∆14.1 vs. -∆13.8, respectively; p-value=0.675). The one-year retreatment rates were lowest for WVTT (3.0%), followed by CT (3.6%), TURP (6.3%), PVP (7.8%), and PUL (8.0%).ConclusionsWVTT provided greater clinical and durability benefits compared to other less invasive treatment options for men with BPH. Given NMA is increasingly used in HTA processes, this study provided systematically synthesized evidence that could facilitate decision-makers in determining new technology coverage decisions globally.

EFFICACY AND SAFETY OF INITIAL DESMOPRESSIN DOSE OF 50 μg IN ELDERLY MALE PATIENTS WITH NOCTURNAL POLYURIA

(Introduction) Low-dose desmopressin is now available for the treatment of nocturia associated with nocturnal polyuria in men, and its usefulness in a dose-dependent manner has been reported. Since side effects such as hyponatremia have reported frequently, the initial dose has been set at 25 μg in many cases considering age and other factors. In the present study, we investigated the efficacy and safety of an initial dose of 50 μg in elderly patients. (Subjects and methods) At Chikugo city hospital, 45 patients were started on desmopressin at an initial dose of 50 μg for nocturia with nocturnal polyuria. Efficacy and safety after one and four weeks were evaluated based on bladder (micturition) diary. The investigated parameters included frequency of nocturnal urination, nocturnal polyuria index, time to first nocturnal void, first nocturnal urine volume, nocturnal urine volume, International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and Athens Insomnia Scale. Physical examinations were also carried out, along with blood tests. (Results) The mean age of the patients was 78.3 years, which was higher than that reported in prior studies. After one week of treatment, there was a significant decrease in the frequency of nocturnal urination and nocturnal urine volume, as well as a prolongation of the time to first nocturnal void, improvement in nocturnal polyuria index, and improvement in IPSS, IPSS-QOL, OABSS, and Athens Insomnia Scale. In terms of safety, adverse events were observed in eight patients (17.8%), and hyponatremia was observed in seven patients (15.6%), which was comparable to the findings of prior reports. (Conclusion) Good therapeutic results were obtained in elderly patients at an initial desmopressin dose of 50 μg, indicating that the drug could be safely administered to elderly patients with regular follow-ups and appropriate withdrawal and dose reductions.

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 (β = 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.

The Impact of Transoral Robotic Surgery on Erectile Dysfunction and Lower Urinary Tract Symptoms in Male Patients with Moderate-to-Severe Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA), lower urinary tract symptoms (LUTS), and erectile dysfunction (ED) are chronic conditions that seriously affect middle-aged men. This study aimed to evaluate the changes in the presence of these conditions after transoral robotic surgery (TORS) for OSA. This prospective observational study recruited 48 men with moderate-to-severe OSA (mean age 40.6 ± 8.1 years) who underwent TORS from October 2019 to November 2021 at a tertiary center. Baseline polysomnographic parameters, Epworth Sleepiness Scale (ESS), and demographic characteristics were measured. The evaluations of LUTS and ED were based on self-administered International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires, respectively, before TORS. The treatment outcomes were assessed three months postoperatively in the patients undergoing TORS due to moderate-to-severe OSA. There was significant Apnea-Hypopnea Index (AHI) reduction from 53.10 ± 25.77 to 31.66 ± 20.34 three months after undergoing TORS (p < 0.001). There was also a significant decrease in the total IPSS score (5.06 ± 5.42 at baseline to 2.98 ± 2.71 at three months postoperatively, p = 0.001), the storage domain, and the voiding domain (p < 0.05). The ED also improved significantly, as seen in the IIEF score (20.98 ± 3.32 to 22.17± 3.60, p = 0.007). The reduction of AHI was associated with changes in body weight and the lowest oxygen saturation (SpO2) levels during sleep (rho = 0.395, p = 0.005; rho = 0.526, p < 0.001, respectively). However, the reduction in AHI was not significantly associated with improvement in IPSS or IIEF scores (p > 0.05). For men with moderate-to-severe OSA, TORS can significantly improve the polysomnography parameters, sleep-related questionnaire scores, and quality of life, and alleviate ED and LUTS. AHI reduction is not a crucial factor for ED and LUTS improvement after TORS for OSA, especially in ED.

Understanding Treatment Response in Individual Profiles of Men with Prostatic Enlargement at Risk of Progression

BackgroundIt is unclear how cumulative multivariable effects of clinically relevant covariates impact response to pharmacological treatments for lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE). ObjectiveTo develop models to predict treatment response in terms of International Prostate Symptom Score (IPSS) and the risk of acute urinary retention (AUR) or BPE-related surgery, based on large data sets and using as predictors baseline characteristics that commonly define the risk of disease progression. Design, setting, and participantsA total of 9167 patients with LUTS/BPE at risk of progression in three placebo-controlled dutasteride trials and one comparing dutasteride, tamsulosin, and dutasteride + tamsulosin combination therapy (CT) were included in the analysis to predict response to placebo up to 24 mo and active treatment up to 48 mo. Outcome measurements and statistical analysisPredictors included age, IPSS, total prostate volume (PV), maximum urinary flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR), α-blocker usage within 12 mo, and randomised treatment. A generalised least-squares model was developed for longitudinal IPSS and a Cox proportional-hazards model for time to first AUR/surgery. Results and limitationsThe vast majority of patients benefit from dutasteride or CT when compared with tamsulosin alone. The predicted IPSS improvement with dutasteride or CT increased with greater PV and severity of symptoms at baseline. The tamsulosin effect was lower with greater baseline PV and tended to decrease over time. Predicted AUR/surgery risk was greater with tamsulosin versus CT or dutasteride; this risk increased with larger PV, higher PVR, and lower Qmax (all at baseline). An educational interactive web-based tool facilitates visualisation of the results (www.bphtool.com). Limitations include: the placebo and active-treatment predictions are from different studies, the lack of similar studies for external validation, and the focus on a population at risk of progression from the 4-yr CombAT study. ConclusionsPredictive modelling based on large data sets and visualisation of the risk for individual profiles can improve our understanding of how risk factors for disease progression interact and affect response to different treatments, reinforcing the importance of an individualised approach for LUTS/BPE management. Patient summaryWe used data from previous studies to develop statistical models for predicting how men with lower urinary tract symptoms or benign prostate enlargement and at risk of disease complications respond to certain treatments according to their individual characteristics.

Efficacy of tadalafil on symptom-specific bother in men with lower urinary tract symptoms.

This multicenter and prospective study was performed to evaluate the efficacy of tadalafil on patient-reported bother for each symptom in men with lower urinary tract symptoms (LUTS). Men with LUTS received 5mg of tadalafil daily for 4 weeks. We assessed change in symptom severity using both international prostate symptom score (IPSS), and overactive bladder symptom score (OABSS), as well as patient-reported quality of life (QOL: bother or satisfaction) for each symptoms using IPSS-visual analog scale (IPSS-VAS) and OABSS-VAS. We found significant improvements in total IPSS (P < 0.001), including voiding symptoms (P < 0.001), storage symptoms (P < 0.001), and QOL (P < 0.001). All VAS measures corresponding to symptoms in IPSS and OABSS also significantly improved (P < 0.001). The most bothersome symptoms for each patient at baseline evaluated by VAS measures significantly improved (P < 0.001). Patients whose most bothersome symptoms at baseline included IPSS-Q7 (nocturia) showed significantly smaller improvement of VAS measure after treatment than those without it (P=0.024). Daily tadalafil significantly improved not only symptom severity of LUTS but also patient-reported QOL on each symptom.

Long-Term Outcome of Prostatic Artery Embolization for Patients with Benign Prostatic Hyperplasia: Single-Centre Retrospective Study in 1072 Patients Over a 10-Year Period.

Assess long-term outcomes of prostatic artery embolization (PAE) for patients with benign prostatic hyperplasia (BPH). Single centre retrospective study from 2009-2019 including 1072 patients who received PAE and had available follow-up. Patients were evaluated yearly at 1-10years post PAE using the International Prostate Symptom Score (IPSS) and quality of life (QoL), prostate volume (PV), prostate-specific antigen (PSA), peak urinary flow rate (Qmax) and postvoid residual (PVR) volume. The need for prostatic medication, re-intervention rates, repeat PAE and prostatectomy rates were assessed with Kaplan-Meier survival analysis and compared between different embolic agents using Cox regression analysis. Mean follow-up time was 4.39 ± 2.37years. At last follow-up visit, mean IPSS and QoL improvements were -10.14 ± 8.34 (p < .0001) and -1.87 ± 1.48 (p < .0001) points, mean PV reduction was -6.82 ± 41.11 cm3 (p = 0.7779), mean PSA reduction was -1.12 ± 4.60ng/mL (p = 0.9713), mean Qmax increase was 2.72 ± 6.38mL/s (p = 0.0005), mean PVR reduction was -8.35 ± 135.75mL (p = 0.6786). There were 335 patients (31.3%) needing prostatic medication after PAE. Re-intervention rates were 3.4%at 1year, 21.1%at 5years and 58.1%at 10years. Repeat-PAE rates were 2.3%at 1year, 9.5%at 5years and 23.1%at 10years. Prostatectomy rates were 1.1%at 1year, 11.6%at 5years and 35.0%at 10years. No significant differences were found between polyvinyl alcohol particles, Bead Block, Embospheres and Embozenes. PAE induces durable long-term LUTS relief, with re-intervention rates of 20% in the first 5years and 30%-60% > 5years post-PAE.

Outcome of Modified Laparoscopic Sacrocolpopexy and Its Effect on Voiding Dysfunction.

Because of its low recurrence rate and safety, laparoscopic sacrocolpopexy (LSC) is an increasingly popular treatment for pelvic organ prolapse (POP). Although LSC may improve voiding function, it can also lead to de novo stress urinary incontinence. The exact effects of LSC on voiding function, and the mechanisms responsible, remain unclear. Therefore, in this study we prospectively evaluated the impact of LSC on voiding function by performing a pre- and postoperative urodynamic study of patients with stage 3 or worse POP. Urinary status was evaluated before and 3 months after LSC. Pre- and postoperative evaluations included medical history, clinical examination, urodynamic studies, chain cystography, and residual urine volume measurement. Urinary symptoms were assessed using the International Prostate Symptom Score (IPSS) and the Overactive Bladder Symptom Score (OABSS). The nonrecurrence rate at 3 months was 82.3%. All recurrences involved bladder prolapse. In addition to the absence of a significant change in OABSS, the improvement in IPSS suggests that subjective voiding symptoms improved. Although the maximum urinary flow rate did not significantly change, bladder volume at first sensation increased, urinary storage function improved, and residual urine volume decreased. There were no perioperative complications, and no patient reported postoperative difficulty in urination or urinary retention. The retrovesical angle significantly decreased. The modified LSC in women with POP provides good functional outcomes in terms of IPSS, post-void residual volume (PVR), and urinary storage function.

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

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. 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. 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). 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.

Beneficial effects of pumpkin seed soft extract on lower urinary tract symptoms and quality of life in men with benign prostatic hyperplasia: a meta-analysis of two randomized, placebo-controlled trials over 12\u2009months

BackgroundIn clinical practice, plant extracts are an option to treat mild-to-moderate lower urinary tract symptoms suggestive of benign prostate hyperplasia (LUTS/BPH). However, only a few herbal extracts have been investigated in long-term placebo-controlled studies. The safety and efficacy of a well-tolerated proprietary pumpkin seed soft extract (PSE) were investigated in two randomized placebo-controlled 12-month studies (Bach and GRANU study). Both trials studied LUTS/BPH patients with an International Prostate Symptom Score (IPSS) ≥13 points at baseline. The Bach study demonstrated positive effects of PSE compared to placebo, but no difference between treatments was observed in the GRANU study. We aimed to assess the efficacy of PSE in a meta-analysis using the patient-level data of these two studies.MethodsPooled analysis was performed in the intention-to-treat set using last-observation-carried-forward (ITT-LOCF). An IPSS improvement of ≥5 points after 12 months of therapy was the predefined response criterion. Logistic regression and ANCOVA models included the covariables treatment group, study, center size, and baseline IPSS. Each analysis was repeated for the per-protocol (PP) set.ResultsThe ITT/PP analysis sets consisted of 687/485 and 702/488 patients in the PSE and placebo groups, respectively. At the 12-month follow-up, the response rates in the PSE group were 3% (ITT) and 5% (PP) higher than those in the placebo group. The odds ratio of response obtained by logistic regression analysis for comparing PSE versus placebo was 1.2 (95% CI 0.9, 1.5), favoring PSE (ITT- LOCF). For the IPSS change from baseline to 12 months, the ANCOVA estimated difference between the treatment groups was 0.7 points (95% CI 0.1, 1.2) in favor of PSE. The variables study, baseline IPSS, and center size had a relevant influence on treatment response.ConclusionAlthough the Bach and the GRANU study showed contradictory results, the analysis in a pooled form still pointed towards an advantage of PSE; namely, more patients in the PSE group showed an IPSS improvement of at least 5 points after 12 months. Therefore, the results of this meta-analysis suggest that patients with moderate LUTS/BPH may benefit from PSE treatment in terms of symptomatic relief.