Benign Prostatic Hyperplasia Impact Index Research Articles

The efficacy and safety of prostatic urethral lift as a minimally invasive therapeutic modality to treat lower urinary tract symptoms while maintaining sexual function in patients with benign prostatic hyperplasia: a systematic review and meta-analysis of randomized controlled trials.

Benign prostatic hyperplasia (BPH) is prevalent among elderly men, necessitating focused attention. The Prostatic Urethral Lift (PUL) procedure, a minimally invasive intervention, has emerged as a promising option for BPH management. It has shown remarkable results in ameliorating lower urinary tract symptoms (LUTS), enhancing quality of life, and preserving sexual function. This study aims to evaluate the effectiveness and safety of PUL in BPH patients. Key databases (MEDLINE, Cochrane CENTRAL, ScienceDirect, EBSCO, Google Scholar) were systematically searched using pertinent terms related to PUL and BPH. Following the PRISMA checklist, we considered only randomized controlled trials (RCTs) from 2013 to 2023. The assessment focused on LUTS, quality of life, sexual function, and adverse events within three months. Follow-up post-treatment mean values compared with controls (Sham) and the improvement from baseline to post-treatment follow-up duration were considered. Statistical analysis and risk of bias evaluation were conducted using Review Manager 5.4.1, presenting results as difference of mean values (MD) and risk ratios (RR). A meta-analysis with a Random Effects Model of 7 RCTs involving 378 confirmed BPH patients demonstrated significant improvements in the PUL arm including International Prostate Symptom Score (IPSS) (MD 5.51, p<0.0001), maximum urinary flow rate (Qmax) (MD 2.13, p=0.0001), BPH Impact Index (BPHII) (MD 2.14, p=0.0001), and IPSS-QoL (MD 1.50, p<0.0001), without significant increase of adverse events (RR 1.51; p=0.50). Positive outcomes were observed in sexual function variables and post-void residual measurements when post-treatment values were compared to baseline. PUL holds advantages over control interventions, providing encouraging prospects for BPH management. This study underscores the need for further exploration of PUL's efficacy and safety in BPH patients.

Clinical Effects of Oral Supplementation of Gamma-Cyclodextrin Curcumin Complex in Male Patients with Moderate-To-Severe Benign Prostatic Hyperplasia-Related Lower Urinary Tract Symptoms

Introduction: Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTSs) in males. Curcumin exhibits anti-inflammatory and anti-tumor properties which may be effective for BPH. This multi-arm observational study evaluated the real-world efficacy of QURMIN^® (Gamma-cyclodextrin-curcumin Complex-CAVACURMIN^®) as single or combination therapy for BPH. Methods: Men with moderate-severe LUTS/BPH, receiving a 6-month supplementation with QURMIN^® alone or in combination with BPH-specific medication were propensity score matched with patients not taking curcumin and then divided into subgroups based on concomitant baseline treatment. Cohorts were compared in the 6-month variation of IPSS, quality of life (IPSS-QoL), Benign Prostatic Hyperplasia Impact Index (BII) and uroflowmetry parameters. Curcumin tolerability was evaluated in terms of discontinuations and adverse effects. Results: The 1:1 propensity score matching resulted in a treatment-naïve (n = 152), an alpha-blocker only (AB) (n = 138) and AB + 5-alpha reductase inhibitors (5-ARIs) (n = 78) subgroup. After 6 months, drug-naïve patients taking curcumin reported significant improvement in IPSS-storage (−3.9, p < 0.001), IPSS-voiding (−2.0, p = 0.011), IPSS-total (−5.9, p < 0.001), IPSS-QoL (−3.9, p < 0.001), BII (−2.0, p < 0.001), Q_max (+3.1 mL/s, p < 0.001), Q_mean (+1.9 mL/s, p = 0.005), post-void residual volume (−7.7 mL, p < 0.001), and PSA (−0.3 ng/mL, p = 0.003), compared to controls. Patients taking ABs and curcumin showed improvement in IPSS-storage (−2.7, p < 0.001), IPSS-voiding (−1.3, p = 0.033), IPSS-total (−3.5, p < 0.001), IPSS-QoL (−1.1, p = 0.004), BII (−1.7, p = 0.006), Q_max (+1.0 mL/s, p = 0.006), and PSA (−0.2 ng/mL, p = 0.01). Patients taking curcumin and AB + 5-ARI showed improvement in IPSS-storage (−1.3, p = 0.007), IPSS-total (−1.6, p = 0.034), IPSS-QoL (−1.1, p < 0.001), and BII (−2.0, p < 0.001). No adverse reactions were reported for curcumin supplementation. Conclusion: QURMIN^® (CAVACURMIN^®) led to significant improvements in symptom burden, uroflow parameters, and QoL, without significant additional side effects, thus proving to be a potential new treatment for BPH, either as a single therapy or in addition to standard treatment.

Modeling study of the effect of placebo and medical therapy on storage and voiding symptoms, nocturia, and quality of life in men with prostate enlargement at risk for progression

BackgroundModeling studies using large datasets from men with lower urinary tract symptoms/benign prostate enlargement (LUTS/BPE) can predict changes in International Prostate Symptom Score (IPSS) and risk of acute urinary retention/surgery under different treatment regimens and according to predictors (baseline characteristics) that commonly define risk of progression. We assessed the impact of treatments on different symptom types (storage, voiding, and nocturia), quality of life (QoL; IPSS Q8), and BPH Impact Index [BII]).MethodsGeneralized least squares models were used to predict each outcome. Data from the CombAT study were used to predict outcomes for active treatments (dutasteride, tamsulosin, combination therapy). Predictors included: age; IPSS total, storage, voiding, nocturia and QoL (IPSS Q8) scores; BII; prostate volume; maximum urine flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR); alpha-blocker usage within 12 months. Data from phase III dutasteride monotherapy studies were used to predict placebo outcomes. Results were visualized using an interactive web-based tool (www.bphtool.com).ResultsCombination therapy provided greater predicted benefit than either monotherapy for all five outcomes for most patient profiles within the CombAT inclusion criteria. PVR and corresponding subscores were significant predictors of change in both storage and voiding subscores. Alpha-blocker use within 12 months, age (storage subscore), and Qmax (voiding subscore) were also significant predictors. PVR, age, Qmax, and nocturia score were significant predictors of change in nocturia. PVR, Qmax, previous alpha-blocker use, total IPSS, and QoL (IPSS Q8) score were significant predictors of change in QoL (IPSS Q8) score. For BII, significant predictors were PVR, age, total IPSS, and BII score. The multivariable effect of covariates and treatments is best visualized through the interactive web-based tool.ConclusionsThis predictive modeling study informs our understanding of how risk factors for disease progression interact and affect treatment impact on different symptom types and QoL scores.

Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study.

To evaluate the safety and efficacy of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). This open-label, single-arm study enrolled eighty subjects with LUTS secondary to BPH who were treated with the Optilume BPH Catheter System. Symptoms were recorded utilizing the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPH-II). Functional improvement was measured utilizing peak urinary flow rate (Qmax) and post-void residual urine volume (PVR). Adverse events were systematically captured and reported at each follow-up visit. Subjects treated with the Optilume BPH Catheter System experienced a significant improvement in LUTS from baseline through 2years of follow-up, as measured by IPSS (22.3 vs 8.2, p < 0.001) and BPH-II (6.9 vs 2.3, p < 0.001). Functional improvement was also significant, with Qmax improving from an average of 10.9mL/s at baseline to 17.2mL/s at the 2-year follow-up and PVR improving from 63.1 to 45.0mL. Treatment-related adverse events were typically minor, with none occurring between 1- and 2-year post-treatment. The Optilume BPH Catheter System is a unique minimally invasive surgical therapy that combines mechanical and pharmaceutical aspects for the treatment of BPH. The functional and symptomatic improvements seen after treatment are significant and have been sustained through 2years in this early feasibility study. NCT03423979, registered February 6, 2018.

MP76-02 AT 4 YEARS, OPTILUME BPH HAS THE HIGHEST SUSTAINED IMPROVEMENT IN PEAK FLOW (QMAX) OF ANY MINIMALLY INVASIVE BPH THERAPY

You have accessJournal of UrologyCME1 Apr 2023MP76-02 AT 4 YEARS, OPTILUME BPH HAS THE HIGHEST SUSTAINED IMPROVEMENT IN PEAK FLOW (QMAX) OF ANY MINIMALLY INVASIVE BPH THERAPY Steven Kaplan, Merycarla Pichardo, Edwin Rijo, Ramon Rodriguez Lay, Gustavo Espino, and Rafael Estrella Steven KaplanSteven Kaplan More articles by this author , Merycarla PichardoMerycarla Pichardo More articles by this author , Edwin RijoEdwin Rijo More articles by this author , Ramon Rodriguez LayRamon Rodriguez Lay More articles by this author , Gustavo EspinoGustavo Espino More articles by this author , and Rafael EstrellaRafael Estrella More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003350.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The EVEREST-I study is a prospective, single arm, multicenter study evaluating functional improvement in urine flow and improvement in lower urinary tract symptoms (LUTS) after treatment with the Optilume BPH System, a novel minimally-invasive treatment for Benign Prostatic Hyperplasia (BPH). Optilume BPH utilizes mechanical dilation of the prostatic urethra to achieve an anterior commissurotomy while delivering the drug paclitaxel to maintain long-term urethral patency. METHODS: A total of 80 subjects were enrolled at 6 centers. Follow up is ongoing, with 32 of 72 expected subjects with 4-year follow-up 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). RESULTS: Mean Qmax showed an immediate increase from 10.9 mL/sec at baseline to 18.8 mL/sec at 14 days, which was sustained at 18.1 mL/sec through 4 years post treatment (p<0.001 vs baseline). A paired analysis of those subjects completing the 4-year visit showed a steady Qmax compared to 3-year outcomes (18.1 vs 18.8, p=0.54). IPSS and BPH-II showed significant, immediate improvement from baseline with this improvement maintained through the 4-year follow-up (Table 1). Erectile and ejaculatory function scores were not significantly changed from baseline through 4 years. CONCLUSIONS: The Optilume BPH Catheter System combines mechanical and pharmaceutical aspects for the treatment of BPH, resulting in both an immediate functional improvement by way of creating an anterior commissurotomy and a sustained anatomic result due to the application of paclitaxel to the prostatic urethra during the initial dilation. The functional and symptomatic improvements seen after treatment with Optilume BPH have been sustained through 4 years in this early feasibility study. The sustained improvement in Qmax is superior to any minimally invasive BPH device currently approved. Results from the EVEREST study will be further verified in the ongoing randomized, sham controlled PINNACLE study. Source of Funding: This study was funded by Urotronic, Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1090 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven Kaplan More articles by this author Merycarla Pichardo More articles by this author Edwin Rijo More articles by this author Ramon Rodriguez Lay More articles by this author Gustavo Espino More articles by this author Rafael Estrella 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 ...

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.

Features of patients referring to the outpatient office due to benign prostatic hyperplasia: analysis of a national prospective cohort of 5815 cases.

Evidence on clinical presentation of benign prostatic hyperplasia (BPH) is scarce, and studies involving outpatients are lacking. We aimed to provide an insight into the contemporary Italian scenario of BPH-affected outpatients using symptom scores (International Prostate Symptom Score [IPSS], BPH Impact Index [BII]), and to compare characteristics of patients with known BPH and those first-diagnosed at the visit. "IMPROVING THE PATH" project working group designed a questionary prospectively administered to BPH-affected outpatients by urologists. A cross-sectional study was performed. Data were adjusted for patient age as a potential confounding factor. Of 5815 patients enrolled, BPH was already diagnosed in 4144 (71.3%), and not in 1671 (28.7%). Patients with known BPH, compared to newly diagnosed, were older (median 68 versus [vs] 55), had more frequent smoking (smoker 27.2 vs 22.6%, and ex-smoker 16.4 vs 12.5%) and drinking habits (55.4 vs 45.1%), were more frequently affected by hypertension (60.0 vs 42.4%), obesity (15.3 vs 9.6%), diabetes (17.9 vs 12.5%), and cardiovascular diseases (14.2 vs 9.5%), p < 0.001. At IPSS, moderate and severe symptoms correlated with already known BPH (56.1 vs 47.3% and 24.8 vs 7.8%), whereas newly diagnosed patients showed milder symptoms (44.9 vs 19.1%), all p < 0.001. At BII, concern for one's health and time lost due to urinary problems were higher in patients with known BPH (p < 0.001). For these patients, the urologist changes at least one of the ongoing medications in 63.5%. For patients newly diagnosed, supplements/phytotherapeutics, alpha-blockers, and 5-alfa reductase inhibitors were prescribed in 54.6%, 21.6%, and 7.1%, respectively. Despite medical treatment, natural history of BPH leads to a progressive deterioration of symptoms. This may reflect the difference between newly diagnosed patients and those with known BPH in lifestyle and associated comorbidities. A healthy lifestyle and treatments including local anti-inflammatory agents may delay worsening of symptoms and improve quality of life.

Simplified Chinese version of the international prostate symptom score and the benign prostatic hyperplasia impact index: cross-cultural adaptation, reliability, and validity for patients with benign prostatic hyperplasia.

BackgroundThe aim of this study was to translate and cross-culturally adapt the international prostate symptom score (IPSS) and benign prostatic hyperplasia impact index (BII) into simplified Chinese for mainland Chinese patients with benign prostatic hyperplasia (BPH).MethodsThe original English IPSS and BII were translated into simplified Chinese versions based on cross-cultural adaptation guidelines. Internal consistency was evaluated with Cronbach’s α, then test-retest reliability with intraclass correlation coefficients (ICCs) in stable patients. The validity of these two adaptations was tested by the correlation between the IPSS and BII with visual prostate symptom score (VPSS) and 36 items Short Form Health Survey (SF-36). The floor and ceiling effects were calculated by the proportion of participants who obtained the highest and lowest possible score.ResultsA total of 105 native Chinese-speaking patients with BPH were enrolled. Cronbach’s α was over 0.75 for the simplified Chinese IPSS (IPSS 0.815; IPSS-symptom 0.782) and 0.709 for the simplified Chinese BII, indicating acceptable internal consistency. The ICCs for the test-retest reliability were over 0.75 (IPSS, r = 0.836; IPSS-symptom, r = 0.801; IPSS-quality of life, r = 0.794; BII, r = 0.758), indicating excellent test-retest reliability. There were very good positive correlations between IPSS and BII (r = 0.605), as well as VPSS (r = 0.634), and very good or good negative correlations between IPSS-Qol and SF-36 physical functioning (r = −0.621), and vitality (r = −0.659), and between BII and SF-36 physical functioning (r = −0.421). No floor or ceiling effect was detected in the simplified Chinese IPSS and BII.ConclusionsThis study indicates that the simplified Chinese IPSS and BII are reliable and valid measurements of the symptom and quality of life among Chinese patients with BPH, which is likely to be widely used in this population.

Rezūm therapy for ≥80-mL benign prostatic enlargement: a large, multicentre cohort study.

To evaluate the efficacy and safety of Rezūm therapy in benign prostatic hyperplasia (BPH) patients with prostates ≥80 mL. A prospective registry was established at two high-volume Canadian centres. Patients had baseline medical history documented, and uroflowmetry and questionnaire results were recorded over 12 months. Eighty-three patients (median [interquartile range {IQR}] age 69.2 [63.2, 74.8] years) with a prostate size ≥80 mL were included. The median (IQR) prostate volume was 100.0 (88.5, 115.0) mL and 65% had a median lobe. Twenty-one patients had prior urinary retention. The median (IQR) number of injections was 13 (11, 15) and catheterization duration was 9 (7, 14) days. International Prostate Symptom Scores (IPSSs) improved by 24%, 57% and 59% at 1, 3 and 12 months, respectively (P < 0.001). IPSS Quality of Life (QoL) scores improved by 27%, 56% and 70% at these same timepoints (P < 0.001). Maximum urinary flow rate improved by 55% at 3 months (P = 0.002) and 59% at 12 months, and post-void residual urine volume improved by 58% at 3 months (P = 0.006). BPH Impact Index scores improved by 57% at 3 months and 71% at 12 months. International Index of Erectile Function-15 scores improved by 15% at 6 months, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction scores improved by 22.4% at 1 month. Three patients (3.6%) noted reduced/anejaculation. No events of Clavien-Dindo grade III or higher occurred. This study demonstrates, for the first time, the safety and efficacy of Rezūm therapy in large glands >80 mL. IPSS improved by 59% and IPSS QoL score improved by 70% at 12 months. Objective maximum urinary flow measures improved at 12 months by 59%, while erectile and ejaculatory function remained preserved.

Impact of drug use on patient symptom score and quality of life in benign prostatic hyperplasia patients

Introduction: To assess the drug use pattern for treating benign prostatic hyperplasia (BPH) patients and its impact on patient symptom score and quality of life (QoL) of these patients. Materials and Methods: After getting approval from the Indian Council of Medical Research, Institutional Ethics Committee and after obtaining written informed consent from 103 BPH patients, their demographic data, drugs prescribed to them, and scores of International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BII) were recorded. Patients were reassessed for changes in scores of IPSS, BII, and drug prescription (if any) on the 15th, 30th, and 60th days. Results: 68.93% of patients received drug as a single entity. Patients were classified according to their presenting symptoms as severe, low moderate, and mild with a mean total IPSS score of 16.73% ± 6.6. 37.86% of patients were dissatisfied with QoL and 24.27% of patients had mixed opinion with a mean score of 3.39 ± 1.08. There was a low, medium, moderate, and high total score of BII with a mean BII score of 4.02 ± 2.51. Significant changes were seen in total BII score and frequency of urination on day 15; weak stream, nocturia, total score, and QoL on day 30; and intermittency and urgency on day 60. Incomplete emptying of bladder and straining showed nonsignificant changes. Age and total IPSS score, age and QoL, and age and total BII score showed a negative correlation. Total IPSS score and QoL, total IPSS and BII score, and QoL and total BII score showed a positive correlation. Conclusion: Nonsurgical pharmacological intervention had a positive impact on the IPSS and BII score and health-related QoL in BPH patients.

Short-term efficacy and safety of second generation bipolar transurethral vaporization of the prostate (B-TUVP) for large benign prostate enlargement: Results from a retrospective feasibility study.

BackgroundTo investigate the efficacy and safety of a second-generation bipolar transurethral electro vaporization of the prostate (B-TUVP) with the new oval-shaped electrode for large benign prostatic enlargement (BPE) with prostate volume (PV) ≥100ml.Materials and methods100 patients who underwent second-generation B-TUVP with the oval-shaped electrode for male lower urinary tract symptom (LUTS) or urinary retention between July 2018 and July 2020 were enrolled in this study. The patients’ characteristics and treatment outcome were retrospectively compared between patients with PV <100ml and ≥100ml.Results17/41 (41.5%) cases of PV ≥100ml and 24/59 cases (40.7%) of PV <100ml were catheterised due to urinary retention. The duration of post-operative catheter placement and hospital-stay of PV ≥100ml (3.1±1.3 and 5.6±2.3 days) were not different from PV <100ml (2.7±1.2 and 5.0±2.4 days). In uncatheterised patients (N = 59), post-void residual urine volume (PVR) significantly decreased after surgery in both groups, however, maximum uroflow rate (Qmax) significantly increased after surgery only in PV <100ml but not in PV ≥100ml. Voiding symptoms and patients’ QoL derived from International Prostate Symptom Score (IPSS), IPSS-QoL (IPSS Quality of Life Index) and BPH Impact Index (BII) scores, significantly improved after B-TUVP in both groups. Catheter free status after final B-TUVP among patients with preoperative urinary retention was achieved in 18/24 (75.0%) and 14/17 (82.1%) cases in patient with <100ml and ≥100ml, respectively. There was no significant difference in post-operative Hb after B-TUVP, which was 97.0±5.4% of baseline for PV <100ml and 96.9±6.1% for PV ≥100ml and no TUR syndrome was observed.ConclusionsThis is the first study investigating short-term efficacy and safety of second-generation B-TUVP with the oval-shaped electrode on large BPE. B-TUVP appears to be effective and safe for treating moderate-to-severe lower urinary tract symptoms and urinary retention in patients with large BPE.

Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial.

Introduction and Objective: Prolieve® transurethral thermodilatation (TUTD) is the only third-generation transurethral microwave thermotherapy (TUMT) device that incorporates balloon dilation/compression of the prostatic urethra with cooled TUMT, at ≤50 W power. We evaluated its 5-year efficacy in the treatment of symptomatic benign prostatic hyperplasia (BPH) in an open-label prospective multicenter trial. Methods: Eligible patients with American Urological Association symptom index score (AUASS) ≥9, peak urine flow rate (Qmax) <12 mL/s, and prostate size 20-80 g without obstructing median lobe were enrolled. Prolieve TUTD was delivered in the office setting under local anesthesia. AUASS, quality of life (QOL), BPH impact index (BPHII), Qmax, and other measures were assessed at baseline, and at least annually thereafter to year 5. Adverse events (AEs) were recorded. Treatment success over time was analyzed using the Kaplan-Meier method while changes from baseline were evaluated using paired t-tests. Results: Intention to treat population was 225, of whom 220 with a mean (standard deviation) age of 65 (5.9) completed treatment. 187/220 (85%) did not require urethral catheterization. AUAS, QOL, and BPHII scores significantly improved from baseline in ≤3 months, with sustained improvements to year 5. Qmax also significantly improved from baseline at each annual follow-up evaluation. Cumulative 5-year surgical retreatment rate was 14.2% (95% confidence interval 9.5-20.8). Transient urinary urgency and dysuria were the most reported AEs. Conclusions: Prolieve TUTD is a safe and effective treatment option for BPH, with durable long-term improvements in voiding symptoms and urinary flow rates. It has a low catheterization rate and sexual side effects are rare. Clinical Trials.gov Registration Number: NCT02021032.

Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia.

BackgroundErectile dysfunction (ED) and ejaculatory dysfunction (EjD) are known outcomes of traditional surgery and some pharmacotherapies for treatment of benign prostatic hyperplasia (BPH). Minimally invasive treatment options, including water vapor thermal therapy (WVTT), are now available to treat lower urinary tract symptoms (LUTS) due to BPH.AimThe objective of this analysis was to evaluate long-term impact of a single water vapor thermal therapy procedure on erectile and ejaculatory function in subjects enrolled in the Rezum II prospective, multicenter, randomized, blinded controlled trial.MethodsFifteen centers enrolled 197 subjects with International Prostate Symptom Score (IPSS) ≥ 13, maximum flow rate (Qmax) ≤ 15 mL/s, and prostate volume 30–80 cc. Subjects were randomized (2:1) to (WVTT) or sham procedure (control) and followed for 5 years. Erectile and ejaculatory functions were quantitatively assessed at baseline and yearly thereafter. After 3 months, control subjects could opt to requalify for cross-over to WVTT and were followed for 5 years. Results of the per protocol analysis were reported previously. The current post hoc analysis was performed on all treated subjects who were sexually active at baseline with no other surgical or medical management for BPH during the 5-year study period.OutcomesLUTS was evaluated using IPSS, Benign Prostatic Hyperplasia Impact Index (BPHII), and Qmax. Sexual function was assessed using the International Index of Erectile Function (IIEF-EF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).ResultsA total of 197 subjects (136 treated, 61 control) were enrolled in the study, and 53 control subjects opted to cross-over and receive WVTT. All subgroups experienced significant, durable improvement in IPSS (P < .0001). Subjects with normal sexual function at baseline had little change in function over 5 years (IIEF-EF: −2.4 ± 8.9, P = .1414; MSHQ-EjD Function: −1.6 ± 3.2, P = .0083; MSHQ-EjD Bother: −0.5 ± 1.6, P = .1107). Subjects with baseline medical history of ED and EjD showed slight decline over time that was not clinically significant (ED, IIEF-EF: −3.0 ± 10.1, P = .1259; MSHQ EjD Function: −2.3 ± 4.7, P = .0158; MSHQ-EjD Bother: −0.1 ± 2.6, P = .7764; EjD, IIEF-EF: −4.1 ± 9.2, P = .0127; MSHQ EjD Function: −1.6 ± 4.8, P = .1970; MSHQ-EjD Bother: −0.4 ± 2.6, P = .440).Clinical ImplicationsTreatment for BPH with Rezum durably improved IPSS without clinically significant impact on sexual function. Patients with baseline ED/EjD may expect continued decline from other causes but are unimpacted by the therapy.Strengths & Limitations, ConclusionThe results are limited by the post-hoc nature of the analysis and attrition over the 5-year follow-up but provide long-term evidence of durable outcomes after treatment with Rezum without impact on sexual function scores. McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med 2021;9:100454.

Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

The International Prostate Symptom Score (IPSS), the quality of life (QoL) score, and the benign prostatic hyperplasia impact index (BII) are three different scales commonly used to assess the severity of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS). Based on a phase II clinical trial including 403 patients with moderate to severe BPH-LUTS, the objectives of this study were to (i) develop traditional pharmacometric and bounded integer (BI) models for the IPSS, QoL score, and BII endpoints, respectively; (ii) compare the power and type I error in detecting drug effects of BI modeling with traditional methods through simulation; and (iii) obtain quantitative translation between scores on the three abovementioned scales using a BI modeling framework. All developed models described the data adequately. Pharmacometric modeling using a continuous variable (CV) approach was overall found to be the most robust in terms of type I error and power to detect a drug effect. In most cases, BI modeling showed similar performance to the CV approach, yet severely inflated type I error was generally observed when inter-individual variability (IIV) was incorporated in the BI variance function (g()). BI modeling without IIV in g() showed greater type I error control compared to the ordered categorical approach. Lastly, a multiple-scale BI model was developed and estimated the relationship between scores on the three BPH-LUTS scales with overall low uncertainty. The current study yields greater understanding of the operating characteristics of the novel BI modeling approach and highlights areas potentially requiring further improvement.

The impact of medical therapy for benign prostatic obstruction on the health-related quality of life at tertiary hospital: A prospective study

Benign prostatic obstruction (BPO) is a common condition in older men that often result in lower urinary tract symptoms (LUTS). LUTS associated with Benign Prostate Enlargement (BPE) may have significant negative impact on patients’ health-related quality of life as can certain treatments for the condition. This study aimed to determine the impact of medical therapy on health-related quality of life among patients on treatment for BPO.This was a hospital based descriptive study carried out in urology public and private clinics from April to December 2017. All diagnostic and treatment options of patients were decided by attending clinicians of which Patients aged ≥40 years on medical treatment for BPO were included. Symptom and Health Related Quality Life (HRQL) were measured at baseline and at 3 months using the International Prostate Symptom Score (IPSS) and the Benign Prostatic Hyperplasia Impact Index score (BII) tools. A total 150 patients were included in the analysis with a mean age of 54), mean PSA of 4.45ng/ml and a mean prostate volume 54.62cc. Majority, 144(96.5%) had moderate and severe LUTS and 94(63%) men received a combination of tamsulosin and finasteride and 44(29%) men received tamsulosin alone: Medical therapy was associated with overall improvement of quality of life (p&lt;0.001). A combination of tamsulosin and finasteride was associated with more adverse effects. Improvements in Quality of life (QoL) and symptoms were noted across the medical treatments most widely used in real-life practice at MNH to manage patients with BPO. Tamsulosin showed an equivalent efficacy to a combination of tamsulosin and finasteride at third month of therapy with fewer adverse effects.

Reasons to go for Rezūm steam therapy: an effective and durable outpatient minimally invasive procedure.

In this review, we will discuss the state of the literature regarding Rezūm and opportunities for its application in the treatment of BPH. A comprehensive review of original research on convective water vapor thermal therapy (Rezūm) was conducted. Articles related to transurethral resection of the prostate, holmium laser enucleation of the prostate, Aquablation, and greenlight photoselective vaporization of the prostate were reviewed for discussion. Rezūm distinguishes itself from other treatment options by its durable improvement in objective clinical outcomes such as IPSS and BPH Impact Index, while being cost-effective and versatile in its ability to treat a variety of prostate gland morphologies. This treatment option shows good lower urinary tract symptom relief, especially in small-to-moderate prostate sizes (30-80cc). The use of convective heat transfer is unique and allows for localized treatment, avoiding damage to surrounding structures, thus providing an excellent safety profile and sexual function preservation. The current evidence on Rezūm warrants its consideration as a therapeutic alternative to transurethral surgery in selected patients.

Integrated Item Response Theory Modeling of Multiple Patient-Reported Outcomes Assessing Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

In clinical trials within lower urinary tract symptoms due to benign prostatic hyperplasia (BPH-LUTS), the International Prostate Symptom Score (IPSS) is commonly the primary efficacy outcome while the Quality of Life (QoL) score and the BPH Impact Index (BII) are common secondary efficacy markers. The current study aimed to characterize BPH-LUTS progression using responses to the IPSS, the QoL, and the BII in an integrated item response theory (IRT) framework and assess the Fisher information of each scale. The power of this approach to detect a drug effect was compared with an IRT approach considering only IPSS responses. A unidimensional and a bidimensional pharmacometric IRT model, based on item-level IPSS responses in a clinical trial with 403 patients, were extended by incorporating patients’ QoL and summary BII scores over the 6-month trial period. In the developed unidimensional integrated model, the QoL score was found to be the most informative, representing 17% of the total Fisher information, while the combined information content of the seven IPSS items represented 70.6%. In the bidimensional model, “storage” and both storage and “voiding” disability drove QoL and summary BII responses, respectively. Sample size reduction of 16% to detect a drug effect at 80% power was obtained with the unidimensional integrated IRT model compared with its counterpart IPSS IRT model. This study shows that utilizing the information content across the IPSS, QoL, and BII scales in an integrated IRT framework results in a modest but meaningful increase in power to detect a drug effect.

Water vapor thermal therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: Systematic review and meta-analysis.

Background:Water vapor thermal therapy (WVTT) is a minimally invasive procedure for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). There are no known systematic reviews reporting the effectiveness and safety of this increasingly common BPH therapy.Methods:We performed a systematic review and meta-analysis of studies utilizing WVTT for symptomatic BPH. The international prostate symptom score (IPSS), IPSS-quality of life (IPSS-QOL), BPH impact index (BPHII), and maximum flow rate (Qmax) were calculated as the weighted mean difference relative to baseline and reported in minimal clinically important difference (MCID) units. MCID thresholds were −3 for IPSS, −0.5 for IPSS-QOL, −0.5 for BPHII, and 2 mL/s for Qmax. The surgical retreatment rate was calculated using life-table methods.Results:We identified 5 cohorts treated with WVTT from 4 studies (514 patients; 40% with median lobe obstruction) with 2 years median follow-up (range: 6 months to 4 years). The IPSS, IPSS-QOL, BPHII, and Qmax significantly improved at all intervals between 3 months and 4 years; this benefit ranged from 3.3 to 3.8 MCID units for IPSS, 3.9 to 4.6 MCID units for IPSS-QOL, 6.8 to 8.2 MCID units for BPHII, and 1.5 to 3.0 MCID units for Qmax. The surgical retreatment rate was 7.0% at 4 years of follow-up data. Most adverse events were nonserious and transient; dysuria, urinary retention, and urinary tract infection were most common. No cases of de novo erectile dysfunction occurred.Conclusions:WVTT provided improvement in BPH symptoms that exceeded established MCID thresholds, preserved sexual function, and was associated with low surgical retreatment rates over 4 years.

392 - Quality of life with pharmacological treatment in patients with benign prostatic enlargement: Results from the evolution European prospective multicenter multi-national registry study

Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2 years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24 months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0–26 years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.