Long-term outcomes after treatment with Optilume BPH: Four-year results from the EVEREST study.

INTRODUCTION: The purpose of this study was to gather initial safety and efficacy data with the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: A total of 80 men with moderate-to-severe LUTS secondary to BPH were enrolled and treated with the Optilume BPH Catheter System. Symptoms were evaluated using the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPHII). Improvement in urinary flow and relief of obstruction was evaluated by way of peak urinary flow rate (Qmax) and postvoid residual urine volume (PVR). Subjects were prospectively queried for adverse events at each study visit, and relatedness to the study device were evaluated by the investigators, as well as centrally adjudicated by the study principal investigator. RESULTS: Previous reports of symptom improvement in this cohort were maintained through four-year followup, with a significant reduction in IPSS and IPSS quality of life maintained through four years (-12.1, -2.8, respectively). Clinically meaningful improvement in Qmax was maintained in the majority of subjects, with an average improvement from baseline of +5.6 mL/sec. No treatment-related adverse events were reported in the long-term followup period. CONCLUSIONS: Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and functional improvement in flow rate. These results indicate the unique mechanism of action for Optilume BPH successfully achieves an immediate mechanical effect that is maintained long-term through incorporation of paclitaxel to maintain patency.

Aquablation at 4-years: Real World Data From the Largest Single-center Study With Associated Outcomes Follow-up.

OBJECTIVE: To report real-world experience of 4-year safety and efficacy outcomes of Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH). METHODS: This is a prospective single-center, observational study evaluating the outcomes of robotic-assisted Aquablation therapy for moderate-to-severe BPH between December 2019 and December 2023. Patient-level data included age, prostate volume, IPSS score, peak urinary flow rate (Qmax), post-void residual (PVR) were evaluated at 3 M, 6 M, and Years 1-4. Primary outcomes included change in IPSS score, change in Qmax, change in PVR, preservation of antegrade ejaculation, and complications. RESULTS: In this cohort of 330 men, mean prostatic volume was 110.3 mL (range 38-330 mL) at baseline. International Prostate Symptom Score (IPSS) improved from a baseline of 23.8 (SD 8.4) to 6.9 (SD 2.9) at 4 years. Mean peak urinary flow rate (Qmax) also demonstrated improvement and increased from 6.4 mL/sec (SD 4.2) to 17.4 mL/sec (SD 5.5) at 4 years. At 1 year, mean prostate volume reduction was 45.5 mL (-41.3%). Postoperative antegrade ejaculation was preserved in 249/250 men (99.6)% of men. Complications included urinary tract infection within first month after procedure in 37 (11.2%) and bleeding requiring blood transfusion in 11 (3.3%). Thirteen patients (3.9%) required a second procedure including 2 for post-operative bleeding, 1 for a bladder neck disruption and 10 (3.0%) for transurethral resection of residual anterior tissue. CONCLUSION: We demonstrate Aquablation to not only be safe but also providing durable outcomes at 4 years for men with BPH.

On-Site More Frequent Dialysis May Hasten Return Home for Nursing Home End-Stage Renal Disease Patients.

BACKGROUND: A direct outcome comparison between Skilled nursing facility (SNF) patients receiving on-site more frequent dialysis (MFD) targeting 14 hours of treatment over five sessions weekly compared to on-site conventional dialysis for death, hospitalization and speed of return home has not been reported. METHODS: From Jan 1, 2022, to July 1, 2023, in a retrospective prospective observational design, using an intent to treat and competing risk strategy, all new admissions to an on-site in SNF dialysis service admitted to nursing homes with on-site MFD dialysis were compared to admissions to nursing homes providing on-site conventional dialysis for the outcome goal of 90 day cumulative incidence of discharge to home, while monitoring safety issues represented by the competing risks of hospitalization and death. RESULTS: 10,246 MFD dialytic episodes and 3,451 conventional dialytic episodes were studied in 195 nursing homes in 12 states. At baseline the MFD population was consistently sicker than CONVENTIONAL dialysis population with a first systolic blood pressure in 23% vs 7.6% (p<.001), lower mean hemoglobin (9.3g/dl vs 10.4g/dl; p<.001), lower iron saturation (25.7% vs 26.6%; p=0.02), higher Charlson score (3.5 vs 3.0; p<.001), higher mean age (67.6 vs 66.7; p<.001). ), more complicated diabetes (31% vs 24%; P<.001), cerebrovascular disease ( 12.6% vs 6.8%:p<.001), and congestive heart failure (24% vs 18%). At 42 days, discharge to home was 25% greater in the MFD than conventional group (17.5% vs 14%) without worsened hospitalization or death. CONCLUSION: Despite a handicap of sicker patients at baseline, real-world application of MFD appears to hasten return home from SNFs compared to conventional dialysis. The findings suggests that MFD allows for SNF acceptance of sicker patients, presumably permitting earlier hospital discharge, without safety compromise as measured by death or rehospitalization benefitting hospitals, patients, and payers.

Ejaculation sparing of classic and minimally invasive surgical treatments of LUTS/BPH.

BACKGROUND: The surgical landscape for Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH) has evolved with the introduction of Minimally Invasive Surgical Therapies (MISTs), recognizing the impact of sexual function on patients' well-being, and prioritizing ejaculation-sparing approaches. METHODS: This systematic review explored ejaculation sparing after classic endoscopic procedures and MISTs (iTind, Rezum, Urolift, Aquablation, and TPLA) and a literature search yielded 41 studies. RESULTS: While all procedures demonstrated efficacy in improving LUTS/BPH symptoms (IPSS, QoL, Qmax), a subset of studies evaluated ejaculatory function. Positive outcomes were noted, challenging the historical association of BPH surgeries with ejaculatory dysfunction. Variations in study design, patient cohorts, and limited long-term data present challenges. Notably, the lack of baseline specificity, use of alpha-blockers, and non-specific sexual function assessments underscore potential biases. CONCLUSIONS: Despite limitations, the review tentatively concluded that MISTs, including iTind, Rezum, Urolift, Aquablation, and TPLA, appear comparable in sparing ejaculation. Long-term studies are essential to validate sustainability, and comparative research should assess trade-offs between MISTs and traditional surgeries. Incorporating patient-reported outcomes and quality of life assessments will enhance future investigations, refining MISTs as standard therapeutic options for LUTS/BPH.

The Role of Remote Diagnostics to Better Assess Uroflow Variability: Insights From Combining at Home Uroflows and Frequency Volume Charts From 19,868 Voids Using a Novel, Hand Held, Cellular Embedded Device.

OBJECTIVE: To examine how representative 24-hour data collection is of the overall patient experience utilizing a home uroflow device in men with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Home uroflow data were collected with the iO Urology CarePath device from men at a single urology clinic and retrospectively analyzed. Void characteristics were summarized for data collected over 24 hours compared to data collected over several days or weeks with the device (overall study excludes the 24-hour data). A linear mixed-effects model was used to evaluate differences in average Qmax from voids collected during a single 24-hour period compared to the overall study. RESULTS: A total of 486 men (mean age 67.4) used the device resulting in 465 included in the analysis with a total of 15,521 voids in the overall study and 4347 voids in the single-day analysis. Average Qmax from the model was 11.2 mL/s (95% CI: 10.80, 11.65) and 11.2 mL/s (95% CI: 10.81, 11.64) in the 24-hour and overall study groups, respectively. Both groups had similar between (20.3% vs 20.4%) and within-subject (12.0% vs 11.9%) variance. The difference in Qmax was not significantly different (P = .970). A subgroup analysis including voids >150 mL yielded similar results. CONCLUSION: Data show variability in voiding parameters, but similar average Qmax collected in 24 hours as compared to several days/weeks. The combination of home uroflowmetry with frequency-volume chart information can provide objective data and a unique perspective on uroflow variability (UFV) for clinician review to support the development of individualized patient treatment plans.

Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study).

BACKGROUND: Patient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). METHODS: One-hundred forty-eight adult males with symptomatic BPH were enrolled and randomized in a 2:1 fashion to Optilume BPH or Sham (100 Optilume BPH; 48 Sham). Long-term measures include International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), Post-Void Residual Urine (PVR), quality of life measures and sexual function. Follow-up beyond one year was limited to those treated with Optilume BPH. RESULTS: At 2 years, 67.5% (56/83 CI 56.3%, 77.4%) of participants in the Optilume BPH arm were symptomatic responders as defined by ≥30% improvement in IPSS without medical or surgical retreatment. IPSS significantly improved from 23.4 ± 5.5 (n = 100) to 11.0 ± 7.0 (n = 74). Qmax improved by 116.8.% (8.9 ± 2.2 (n = 97) to 19.0 ± 16.3 (n = 65)), while PVR showed a slight reduction (83.7 ± 70.3 (n = 99) to 65.9 ± 74.5 (n = 65)). Improvement in uroflowmetry measures was consistent across all prostate volumes. BPH-II improved from 7.0 ± 2.9 (n = 98) to 2.3 ± 2.5 at 1 year (n = 89) and remained consistent at 2.3 ± 2.9 at the 2-years (n = 74), representing a 53.9% improvement. IPSS QoL also improved from 4.6 ± 1.3 (n = 100) at baseline to 2.2 ± 1.5 (n = 74). The most common adverse events reported in the Optilume BPH arm were hematuria and urinary tract infection (UTI). No device and/or treatment related serious adverse events were reported occurring beyond 12 months post-procedure. There was no impact to sexual function. CONCLUSIONS: In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the enduring effectiveness. The Optilume BPH Catheter System provides lasting results that are comparable to the more invasive therapies, while preserving the advantages with being a minimally invasive therapy. REGISTRATION: ClinicalTrials.gov NCT04131907.

Lack of association between the ICIQ-SF questionnaire and the urodynamic diagnosis in men with post radical prostatectomy incontinence / Falta de associação entre o questionário ICIQ-SF e o diagnóstico nos homens portadores de incontinência urinária pós-prostatectomia radical

PURPOSE: To analyze the correlation between the "International Consultation on Incontinence Questionnaire-Short Form" (ICIQ-UISF) survey and the urodynamic findings in men with urinary incontinence (UI) following radical prostatectomy (RP). METHODS: 88 men who presented post-RP UI for a minimum of 1 year were enrolled prospectively. All answered the ICIQ-UISF survey and underwent urodynamic testing. Patients were divided in 3 Groups according to their urodynamic diagnosis: Group 1, patients with sphincteric incontinence (SI) alone; Group 2, patients with mixed UI (SI + Bladder Dysfunction (BD)); and Group 3, patients with BD alone. Data were analyzed using SPSS v16.0 software. RESULTS: There were 51 men in Group 1 (57.9%); 30 in Group 2 (34%); and 7 (7.9%) in Group 3. BD was found in 37/88 patients (42%), but it was the main cause of UI in only 14 patients (15.9%). There was no statistically significant difference among the mean ICIQ-UISFs values from groups 1, 2, or 3 (p>0.05). The symptoms of stress incontinence correlated with the urodynamic finding of SI (r = 0.59), and complaints of urinary urgency correlated with the presence of detrusor overactivity (DO) (r = 0.37), but these complaints did not predict the main cause of UI. CONCLUSION: The etiology of UI following RP cannot be predicted by the ICIQ-UISF survey. Symptoms of stress and urge incontinence predict the findings of SI and DO on urodynamic tests, but they cannot ascertain the main cause of UI. Urodynamic testing remains the gold standard to assess the etiology of post-RP UI.

OBJETIVO: Analisar a relação entre as queixas clínicas mensuradas pelo "International Consultation on Incontinence Questionnaire-Short Form" (ICIQ-UISF) e os achados urodinâmicos em homens com incontinência urinária (IU) após a prostatectomia radical (PR). MÉTODOS: 88 homens que apresentavam IU por um período mínimo de 1 ano após a PR foram incluídos prospectivamente. Todos responderam o questinário "ICIQ-UISF" e foram submetidos a avaliação urodinâmica. Os pacientes foram categorizados em 3 grupos de acordo com o diagnóstico urodinâmico: Grupo 1, pacientes com incontinência esfincteriana isolada (IE); Grupo 2, pacientes com IU mista (IE + disfunção vesical (DV)); e Grupo 3, pacientes com DV isolada. Os dados foram analisados utilizando o software SPSS v16.0. RESULTADOS: Dos 88 pacientes avaliados, após a avaliação urodinâmica, 51 homens (57,9%) apresentaram IE isolada (Grupo 1); 30 homens (34%) apresentaram IE associada a DV (Grupo 2) e 7 homens (7,9%) tinham somente DV (Grupo 3). A DV foi encontrada em 37/88 pacientes (42%), mas foi a principal causa de IU em apenas 14 pacientes (15,9%). Não houve diferença estatisticamente significativa entre os valores das médias do "ICIQ-UISFs" entre os grupos 1, 2 ou 3 (p> 0,05). Os sintomas de incontinência de esforço se correlacionaram com o diagnóstico urodinâmico de IE (r = 0,59), e as queixas de urgência miccional se correlacionaram com a presença de hiperactividade do detrusor na avaliação urodinâmica (r = 0,37), entretanto apesar da correlação encontrada, os sintomas não foram capazes de identificar a principal causa da UI . CONCLUSÃO: A etiologia da UI após a PR não pode ser previsto pelo escore de sintomas obtidos através do "ICIQ-UISF". Os sintomas de perda urinária as manobras de estresse e de urgência miccional estão relacionados a presença de IE e hiperatividade detrusora na avaliação urodinâmica, entretanto estes sintomas não conseguem identificar com segurança qual é o principal fator da IU após a PR.O teste urodinâmico continua sendo o padrão ouro para avaliar a etiologia da IU após a PR.

Correlation between the presence of inguinal hernia and the intensity of lower urinary tract symptoms / Correlação entre a presença de hérnia inguinal e a intensidade dos sintomas do trato urinário inferior

PURPOSE: To verify the correlation between the presence of IH and the intensity of LUTS related to BPH quantified through the International Prostate Symptom Score (IPSS). METHODS: We prospectively selected 52 patients over the age of 55years; Patients were divided into 2 groups. Group 1: composed of 32 patients with IH; Group 2 (control group): composed of 20 patients with no clinical evidence of IH. All patients were assessed using the IPSS, uroflowmetry (Qmax), post-void residual urine volume (PVR) and prostate volume (PV). RESULTS: Groups 1 and 2 presented no difference in PV (p>0.05) and uroflowmetry (Qmax) (p>0.05). There was a statistical significant difference between the PVR mean values between groups 1 and 2. The presence of IH correlated with a higher IPSS score (r=0.38 p<0.05) despite the fact the no difference was detected between the incidence of patients with mild, moderate and severe LUTS in groups 1 and 2. CONCLUSION: Patients with IH present higher IPSS. The role of IPSS as a marker to predict the development of clinical IH still to be determined.

OBJETIVO: Verificar a correlação entre a presença de HI e a intensidade dos STUI quantificados através do escore internacional de sintomas prostáticos (IPSS). MÉTODOS: Foram selecionados prospectivamente 52 pacientes com idade superior a 55 anos; os pacientes foram divididos em 2 grupos. Grupo 1: composto por 32 pacientes portadores de IH, Grupo 2 (grupo controle): composto por 20 pacientes sem evidência clínica de IH. Os parâmetros avaliados foram: sintomas urinários, quantificados através do IPSS; fluxo urinário máximo (Qmax), obtido através da fluxometria livre; resíduo pós miccional (RM) e volume prostático (VP), obtido através do ultrassom transretal. RESULTADOS: Os grupos 1 e 2 não apresentaram diferença significativa em relação ao Qmax e VP (p>0.05). Foi detectada diferença estatística significativa entre em relação ao VR entre os grupos 1 e 2 (p<0.05). A presença de HI se correlacionou com o aumento da intensidade dos STUI (r=0,38; p<0.05). Não foi detectada diferença estatisticamente significativa entre a incidência de pacientes portadores de STUI, leve, moderado ou intenso entre os grupos 1 e 2. CONCLUSÃO: Pacientes portadores de HI apresentam escore de sintomas (IPSS) mais elevados, entretanto o papel dos sintomas urinários como um dos possíveis fatores causadores do aparecimento de HI ainda não foi determinado.