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1.
Urologie ; 63(1): 58-66, 2024 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-38193989

RESUMO

BACKGROUND: Lower urinary tract symptoms suggestive for benign prostatic obstruction (LUTS/BPO) are one of the most frequent diseases in men and can have a significant impact on quality of life. Instrumental therapies are common, and many patients seek minimally invasive treatment options. OBJECTIVE: Presentation and evidence-based evaluation of the minimally invasive therapy for benign prostatic syndrome. MATERIALS AND METHODS: Summary and overview of chapters 11-13 on minimally invasive therapies for LUTS/BPO of the current long version of the German S2e guideline. RESULTS: In case of absolute indication for surgery or after unsatisfactory or undesired medical therapy, minimally invasive treatments such as UroLift® (Neotract Inc., Pleasanton, CA, USA), Rezá¿¡m™ (Boston Scientific, Malborough, MA, USA), iTIND™ (Olympus America Inc., Westborough, MA, USA), and prostatic artery embolization (PAE) can be considered. These indirect/delayed ablative therapies offer lower morbidity and the possibility of performing them under local anesthesia, but they are inferior to direct ablative/resective techniques in terms of effectiveness and sustainability. CONCLUSIONS: The updated German S2e guideline summarizes evidence-based recommendations for new minimally invasive therapies for LUTS/BPO, which present alternative treatment options for selected patients.


Assuntos
Embolização Terapêutica , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Obstrução Uretral , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Próstata/irrigação sanguínea , Embolização Terapêutica/efeitos adversos , Qualidade de Vida , Resultado do Tratamento , Sintomas do Trato Urinário Inferior/etiologia , Obstrução Uretral/etiologia
3.
Urologie ; 62(10): 1048-1056, 2023 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-37796278

RESUMO

BACKGROUND: Lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH, in German guidelines: benign prostatic syndrome [BPS]) is considered the most common disease of the lower urinary tract in men and can have a tremendous impact on the quality-of-life of affected patients. Conservative and pharmacological therapy of this disease are of great importance, both in improving LUTS and reducing progression-related complications. OBJECTIVES: Presentation of the conservative and pharmacological treatment options according to the current German S2e guideline on BPS. MATERIALS AND METHODS: Summary and overview of chapters 9 and 10 of the current German S2e guideline on BPS. RESULTS: In addition to a controlled watchful waiting for BPS patients without an absolute indication for prostate surgery, a variety of phytopharmacological formulations and synthetic drugs according to the symptomatology and clinical progress are available. Phytotherapy should, due to inconsistent study data, only be considered for mild to moderate symptoms. Synthetic drugs include alpha-blockers, 5α-reductase inhibitors, phosphodiesterase inhibitors, antimuscarinics and, more recently, the ß3-agonist mirabegron in the current guideline. In addition, various combination therapies are listed and evaluated according to their indications, effects and side effects. CONCLUSIONS: The current German S2e guideline on the diagnosis and treatment of BPS provides an evidence-based foundation for finding the best possible and most effective medication.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Medicamentos Sintéticos , Masculino , Humanos , Hiperplasia Prostática/diagnóstico , Resultado do Tratamento , Próstata , Antagonistas Adrenérgicos alfa/uso terapêutico , Sintomas do Trato Urinário Inferior/diagnóstico , Medicamentos Sintéticos/uso terapêutico
4.
Artigo em Inglês | MEDLINE | ID: mdl-37794168

RESUMO

BACKGROUND: Modeling 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]). METHODS: Generalized 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 ). RESULTS: Combination 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. CONCLUSIONS: This 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.

5.
Urologie ; 62(11): 1177-1185, 2023 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-37823934

RESUMO

BACKGROUND: Lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) are one of the most common diagnoses in clinical practice. Bothersome LUTS impact considerably quality of life of men and may cause severe complications without treatment. According to the diagnostic assessment every patient should be treated with an adequate therapy. Management comprises a conservative approach, medication, novel minimally invasive options, and surgical procedures with the aim to remove the obstructing adenoma. The German guideline panel has updated the German guidelines on diagnostic evaluation and management of LUTS due to BPO. OBJECTIVES: Evidence-based recommendations of surgical treatment options of LUTS due to BPO are evaluated. MATERIALS AND METHODS: Chapters 11.1.1 and 11.2 of the updated German S2e guideline on the management of LUTS due to BPO are summarized as a review article. RESULTS: A treatment algorithm based on current evidence has been proposed. It is considered to provide guidance for the selection of the best procedure according to the needs of the patient. Anatomic features of the prostate, the patients' morbidity, and the preservation of ejaculatory function are taken into account for the choice of the best procedures. These surgical options can be divided into techniques with direct, delayed or no removal of the adenoma, procedures with suprapubic access, and embolizing approaches. CONCLUSIONS: The updated German S2e guideline on the management of LUTS due to BPO provides evidence-based recommendations for the selection of the best procedure according to the needs of the individual patient.


Assuntos
Adenoma , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Obstrução Uretral , Masculino , Humanos , Hiperplasia Prostática/complicações , Qualidade de Vida , Próstata , Obstrução Uretral/complicações , Sintomas do Trato Urinário Inferior/diagnóstico , Adenoma/complicações
6.
Eur Urol Focus ; 2023 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-37758614

RESUMO

CONTEXT: The incidence and risk factors for persisting pharmacotherapy following surgical treatment of benign prostatic obstruction (BPO) remain unclear. OBJECTIVE: To evaluate the evidence on persisting pharmacotherapy of lower urinary tract symptoms (LUTS) following surgical treatment of BPO. EVIDENCE ACQUISITION: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses checklist (PROSPERO ID CRD42022310598). PubMed and EMBASE databases were searched in February 2022, with an updated search in October 2022. Studies evaluating pharmacotherapy in men aged >18 yr following surgical treatment of BPO were included. EVIDENCE SYNTHESIS: Overall, ten nonrandomized studies and one post hoc analysis of two randomized controlled trials were included. The incidence of persisting medical treatment or medical retreatment varied strongly between time points and investigated surgical techniques. Among the investigated techniques, most data were available for transurethral resection of the prostate (TURP). Persistence of pharmacotherapy after TURP at 6 mo ranged from 8.7% to 57% for the use of alpha-blockers. The use of 5-alpha reductase inhibitors after TURP ranged from 5.5% at 6 mo to 19% at 6-24 mo, whereas the use of antimuscarinics ranged from 3.4% to 28.1% at 6 mo. Data on initiation of pharmacotherapy after TURP also differed between study and type of medication. At 12 yr, the use of alpha-blockers after TURP ranged from 12% to 38%. The risk factors associated with medication after BPO surgery were age, history of diabetes mellitus, history of cerebrovascular accident, preoperative medication use, as well as surgical techniques other than laser enucleation of the prostate. CONCLUSIONS: Pharmacotherapy for LUTS is common after BPO surgery. The outcomes following different surgical techniques are heterogeneous, with limited data from randomized controlled trials. Future studies on surgical treatment of BPO should include the use of LUTS-related pharmacotherapy after BPO surgery as a secondary endpoint. PATIENT SUMMARY: In the present systematic review, we investigated the risk of ongoing or novel therapy with drugs following surgery for benign prostate enlargement. We found that a non-negligible proportion of men will need to take drug therapy after surgery. Certain risk factors can be identified, which are associated with a higher risk of drug therapy after surgery.

7.
Urologie ; 62(8): 805-817, 2023 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-37401972

RESUMO

BACKGROUND: Lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; in German guidelines: benign prostatic syndrome [BPS]) is the most frequent urological disease in men and can result in a considerable deterioration of quality-of-life. BPS can be associated with LUTS, benign prostatic enlargement (BPE), and bladder outlet obstruction (BOO) or benign prostatic obstruction (BPO), respectively. The expert group on BPS of the German Society of Urology has re-evaluated the tests for the assessment of BPH and provides evidence-based recommendations. OBJECTIVES: Presentation and evidence-based rating of tests for the assessment of patients with BPS. MATERIALS AND METHODS: Summary and overview of chapters 5, 6, and 8 of the latest long version of the German S2e guideline on BPS. RESULTS: The diagnostic work-up should clarify (1) whether the complaints of the patient are caused by BPS, (2) how relevant the complaints are and whether treatment is necessary, (3) whether complications of the lower or upper urinary tract already exist, and (4) which treatment will be most suitable. Baseline assessment should be done in all BPS patients and include history, measurement of LUTS and quality-of-life, urinalysis, serum prostate-specific antigen, post-void residual, ultrasound of the lower urinary tract, including measurements of prostate volume, intravesical prostatic protrusion and detrusor wall thickness, and ultrasound of the upper urinary tract. Additional tests can follow when questions remain unanswered after baseline assessment. These optional tests include bladder diaries, uroflowmetry, serum creatinine, urethrocystoscopy, other noninvasive tests for the determination of BOO/BPO such as penile cuff test, condom catheter method and near-infrared spectroscopy, and other imagining tests such as X­ray and MRI investigations. CONCLUSIONS: The updated German S2e guideline summarizes evidence-based recommendations on the diagnostic work-up, including the assessment of the BPS components BPE, LUTS, and BOO/BPO.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Obstrução do Colo da Bexiga Urinária , Masculino , Humanos , Hiperplasia Prostática/diagnóstico , Próstata/diagnóstico por imagem , Bexiga Urinária/diagnóstico por imagem , Ultrassonografia/efeitos adversos , Sintomas do Trato Urinário Inferior/diagnóstico , Obstrução do Colo da Bexiga Urinária/complicações
8.
Geburtshilfe Frauenheilkd ; 83(4): 410-436, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37034416

RESUMO

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as "Female stress urinary incontinence," "Female urge incontinence" and "Use of Ultrasonography in Urogynecological Diagnostics" for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB). Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline "Urinary Incontinence in Adults" published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated. Recommendations The short version of this guideline consists of recommendations and statements on the surgical treatment of female patients with stress urinary incontinence and urge incontinence. Specific solutions for the diagnostic workup and treatment of uncomplicated and complicated urinary incontinence are discussed. The diagnostics and surgical treatment of iatrogenic urogenital fistula are presented.

9.
Geburtshilfe Frauenheilkd ; 83(4): 377-409, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37034417

RESUMO

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as "Female stress urinary incontinence," "Female urge incontinence" and "Use of Ultrasonography in Urogynecological Diagnostics" for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB). Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline "Urinary Incontinence in Adults" published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated. Recommendations The short version of this guideline consists of recommendations and statements on the epidemiology, etiology, classification, symptoms, diagnostics, and treatment of female patients with urinary incontinence. Specific solutions for the diagnostic workup and appropriate conservative and medical therapies for uncomplicated and complication urinary incontinence are discussed.

10.
Eur Urol Focus ; 9(1): 178-187, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35985933

RESUMO

BACKGROUND: It 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). OBJECTIVE: To 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 PARTICIPANTS: A 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 ANALYSIS: Predictors 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 LIMITATIONS: The 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. CONCLUSIONS: Predictive 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 SUMMARY: We 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.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Retenção Urinária , Masculino , Humanos , Dutasterida/uso terapêutico , Tansulosina/uso terapêutico , Azasteroides/uso terapêutico , Sulfonamidas/uso terapêutico , Resultado do Tratamento , Quimioterapia Combinada , Hiperplasia Prostática/complicações , Hiperplasia Prostática/tratamento farmacológico , Hiperplasia Prostática/cirurgia , Retenção Urinária/complicações , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/complicações , Progressão da Doença
12.
Neurourol Urodyn ; 42(1): 249-255, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36335610

RESUMO

AIMS: The efficacy of the transurethral convective interstitial radiofrequency water vapor thermal ablation of the prostate with the Rezum system for the treatment of male lower urinary tract symptom due to benign prostatic hyperplasia is well proven. The improvement of urodynamic parameters obtained from a simple uroflowmetry cannot measure the effect of water vapor injection on the bladder outlet obstruction. METHODS: This monocentric retrospective pilot study analyzes the data of pressure-flow studies performed before and after 17 Rezum procedures to answer the question whether thus obtained ablation of prostate tissue has a disobstructive effect on the bladder outlet. RESULTS: All the functional outcomes were consistently improved after the procedure, with a median flowrate increase of 5.1 ml/s (p = 0.0022) and a median postvoid residual urine (PVR) reduction of 100 ml (p = 0.0042). The prostate volume was reduced by 40% (p < 0.0001) and the median Bladder Outlet Obstruction Index (BOOI) reduction was 53.8 (p < 0.0001). CONCLUSIONS: These data show that the possibility to significantly reduce the obstruction grade with even a single Rezum procedure is concrete and seems to be independent from the degree of the obstruction grade.


Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Obstrução do Colo da Bexiga Urinária , Masculino , Humanos , Próstata/cirurgia , Vapor , Obstrução do Colo da Bexiga Urinária/etiologia , Obstrução do Colo da Bexiga Urinária/cirurgia , Urodinâmica , Projetos Piloto , Estudos Retrospectivos , Hiperplasia Prostática/diagnóstico , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Resultado do Tratamento
13.
J Comp Eff Res ; 11(13): 919-925, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35881009

RESUMO

WHAT IS THIS SUMMARY ABOUT?: This is a summary of a study originally published in Neurourology and Urodynamics. Overactive bladder is a medical condition that causes an urgent need to urinate, which can cause accidental urination. Fesoterodine is a medication used to treat overactive bladder. Because we don't know how likely it is that an individual patient will achieve a level of improvement in their overactive bladder symptoms, researchers analyzed results of 6 studies of patients with overactive bladder who were treated with fesoterodine. WHAT WERE THE RESULTS?: Although complete resolution of all symptoms was rare with fesoterodine treatment, a resolution of accidental urination was more common, which is the most important treatment goal for many patients. After taking fesoterodine, episodes of accidental urination were more likely to be reduced or completely absent than episodes of an urgent need to urinate. WHAT DO THE RESULTS OF THE STUDY MEAN?: These results can help patients with overactive bladder understand their own chances of treatment success with fesoterodine and can help doctors support their patients on what to expect regarding their specific symptoms and concerns. ▪Toviaz (fesoterodine) is approved to treat the condition that is discussed in this summary. Approval varies from country to country; please check with your local health provider for more details. ▪This summary reports the combined results of 6 studies. The results of individual studies may vary from the combined study results presented here. Individuals should make treatment decisions based on all available evidence. ClinicalTrials.gov NCT number: NCT01302054, NCT01302067, NCT00444925, NCT00611026, NCT00220363, and NCT00138723.


Assuntos
Bexiga Urinária Hiperativa , Compostos Benzidrílicos/uso terapêutico , Humanos , Idioma , Resultado do Tratamento , Bexiga Urinária Hiperativa/tratamento farmacológico
15.
J Urol ; 208(2): 333-340, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35422136

RESUMO

PURPOSE: The purpose of this study was to investigate the effect of a surgically constructed bilateral peritoneal flap (PIF) as an adjunct to robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND) on the incidence of lymphoceles. MATERIALS AND METHODS: A total of 530 men with localized prostate cancer underwent a RARP with bilateral extended standardized PLND in a prospective randomized controlled trial. In group A, a PIF was created by suturing the margins of the bladder peritoneum to the ipsilateral endopelvic fascia at 2 points on each side. In group B, no PIF was created. The patients were followed 30 and 90 days after the surgery to assess the incidence, extent and treatment of lymphoceles. RESULTS: Lymphoceles occurred in 22% of group A patients and 33% of group B patients (p=0.008). Symptomatic lymphoceles were observed in 3.3% of group A patients and 8.1% of group B patients (p=0.027). Lymphoceles requiring intervention occurred significantly less frequently in group A patients (1.3%) than in group B patients (6.8%, p=0.002). The median lymphocele size was 4.3 cm in group A and 5.0 cm in group B (p=0.055). No statistically significant differences were observed in minor or major complications unrelated to lymphocele, blood loss, or surgical time between groups A and B. CONCLUSIONS: Bilateral PIFs in conjunction with RARP and PLND significantly reduce the total incidence of lymphoceles, the frequency of symptomatic lymphoceles and the rate of associated secondary interventions.


Assuntos
Linfocele , Neoplasias da Próstata , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Incidência , Excisão de Linfonodo/efeitos adversos , Excisão de Linfonodo/métodos , Linfocele/epidemiologia , Linfocele/etiologia , Linfocele/prevenção & controle , Masculino , Pelve , Peritônio/cirurgia , Estudos Prospectivos , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Neoplasias da Próstata/patologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos
16.
Neurourol Urodyn ; 41(5): 1139-1148, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35419807

RESUMO

AIM: The aim of this study is to evaluate safety and efficacy of ASP8302, a novel positive allosteric modulator for the muscarinic M3 receptor (M3-PAM), in patients with underactive bladder (UAB). METHODS: A randomized, double-blind, placebo-controlled multicenter study was performed in adult male/female subjects with UAB, defined as incomplete bladder emptying (postvoid residual volume [PVR] > 100 ml) without significant bladder outlet obstruction and/or overactive bladder. Subjects were randomized (1:1) to receive 4-week oral once-daily administration of 100 mg ASP8302 or matching placebo. Primary endpoint was a change from baseline in PVR measured by catheterization after standardized bladder filling (PVRC2 ). Other endpoints included PVR and bladder voiding efficiency (BVE) measured in various ways, uroflowmetry, bladder diary, and questionnaires. Pressure-flow studies were performed in a subgroup. RESULTS: One hundred and thirty-five patients were randomized (ASP8302 group: 65 patients, placebo group: 70 patients). The median change in PVRC2 was -40.0 ml (ASP8302) versus -35.0 ml (placebo) and the difference between groups was -5.0 ml (p = 0.960). In males, functional and symptomatic outcomes improved, for example, maximum urine flow rate (Qmax ) and detrusor pressure at Qmax (Pdet.Qmax ) increased (mean difference in change ASP8302 vs. placebo: 3.8 ml/s, p = 0.031 and 12.7 cm H2 O, p = 0.034, respectively). Urinary incontinence episodes/24 h decreased in males with preexisting incontinence (mean difference: -0.35; p = 0.028). The incidence of adverse events was similar between study groups (ASP8302: 33.3%, placebo: 31.4%). In the included subjects, both baseline urine flow and bladder voiding pressure was low. Compared with PVR, simultaneous BVE measurements were more consistent between various methods (spontaneous vs. standardized bladder filling, catheterization vs. ultrasound [US]). CONCLUSIONS: ASP8302 was safe and well tolerated in patients with UAB identified by nonurodynamic clinical criteria, but it did not show efficacy in the primary endpoint. However, in males it showed improvement of symptoms and functional parameters. BVE (using US) is a more optimal outcome measure than PVR in UAB.


Assuntos
Colinérgicos , Bexiga Inativa , Adulto , Colinérgicos/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Masculino , Receptores Muscarínicos , Resultado do Tratamento , Obstrução do Colo da Bexiga Urinária , Bexiga Urinária Hiperativa , Bexiga Inativa/complicações , Bexiga Inativa/tratamento farmacológico , Incontinência Urinária/etiologia
17.
Adv Ther ; 39(6): 2489-2501, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35325367

RESUMO

INTRODUCTION: Unmet expectations are a major cause of perceived treatment failure and discontinuation of treatment. To enable evidence-based counselling of patients on realistic expectations, we determined the chance of patients with overactive bladder becoming free of a given symptom upon treatment with a muscarinic antagonist in a non-interventional setting. METHODS: Two non-interventional studies included 1335 and 745 patients, respectively, who received 30 or 45 mg q.d. propiverine ER for 12 weeks. They were monitored for becoming free of urgency, urinary incontinence, frequency, or nocturia. Analyses were also performed in subgroups defined by basal symptom severity, age, and gender. Categorical data are shown as a percentage of the respective population. Continuous data are expressed as means or as median depending on whether the variability was considered to exhibit a normal distribution. RESULTS: The probability of becoming symptom-free was largest for incontinence and frequency (about 50%), but lesser for urgency (about 20%) and nocturia (about 10%). Greater basal severity of a symptom reduced the chance to become free of that symptom upon treatment, but the chance to become free of incontinence and frequency was still considerable. Age and gender had only minor if any effects on the chance of becoming symptom-free. These findings are in line with those of a limited number of randomized controlled trials. CONCLUSION: These data provide an evidence base for the counselling of patients with overactive bladder on realistic expectations of treatment outcomes. We propose that realistic expectations can lead to greater long-term adherence.


Unmet expectations are a major reason why patients with overactive bladder syndrome discontinue treatment. To enable evidence-based counselling of patients on realistic expectations, we have determined the chance that patients with overactive bladder become free of urgency, incontinence, voiding frequency, and nocturia. Two non-interventional studies included 1335 and 745 patients, respectively, who received 30 or 45 mg q.d. propiverine ER for 12 weeks. Analyses were also performed in subgroups defined by basal symptom severity, age, and gender. The probability of becoming symptom-free was largest for incontinence and voiding frequency (about 50%), but lesser for urgency and nocturia (about 20%). Greater basal severity of a symptom reduced the chance to become free of that symptom upon treatment, but the chance to become free of incontinence and frequency was still considerable. Age and gender had only minor if any effects on the chance of becoming symptom-free. These data provide an evidence base for the counselling of patients with overactive bladder on realistic expectations of treatment outcomes. We propose that realistic expectations can lead to greater long-term adherence.


Assuntos
Noctúria , Bexiga Urinária Hiperativa , Incontinência Urinária , Benzilatos/uso terapêutico , Humanos , Motivação , Noctúria/tratamento farmacológico , Resultado do Tratamento , Bexiga Urinária Hiperativa/tratamento farmacológico
18.
World J Urol ; 40(6): 1419-1425, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35348869

RESUMO

OBJECTIVE: To compare surgical, oncological and functional outcomes between obese vs. normal-weight prostate cancer (PCa) patients treated with robotic-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: We assessed 4555 consecutive RARP patients from a high-volume center 2008-2018. Analyses were restricted to normal-weight vs. obese patients (≥ 30 kg/m2). Multivariable cox regression analyses (MVA) assessed the effect of obesity on biochemical recurrence (BCR), metastatic progression (MP), erectile function and urinary continence recovery. Analyses were repeated after propensity score matching. RESULTS: Before matching, higher rates of pathological Gleason Grade group ≥ 4 (14 vs. 18%; p = 0.004) and pT3 stage (33 vs. 35%; p = 0.016) were observed in obese patients, with similar observations for surgery time, blood loss and 30-day wound- and surgical complication rates. For normal-weight vs. obese patients, BCR- and MP-free rates were 86 vs. 85% (p = 0.97) and 97.5 vs.97.8% (p = 0.8) at 48 months. Similarly, rates of erectile function at 36 months and urinary continence at 12 months were 56 vs. 49% (p = 0.012) and 88 vs. 85% (p = 0.003), respectively. Before and after propensity score matching, obesity had no effect on BCR or MP, but a negative effect on erectile function (matched HR 0.87, 95%CI 0.76-0.99; p = 0.029) and urinary continence recovery (matched HR 0.91, 95%CI 0.84-0.98; p = 0.014). CONCLUSIONS: Obesity did not represent a risk factor of BCR or MP after RARP despite higher rates of adverse pathological features. However, obesity was associated with higher risk of perioperative morbidity and impaired functional outcomes. Such information is integral for patient counselling. Thus, weight loss before RARP should be encouraged.


Assuntos
Disfunção Erétil , Neoplasias da Próstata , Procedimentos Cirúrgicos Robóticos , Disfunção Erétil/epidemiologia , Disfunção Erétil/etiologia , Disfunção Erétil/cirurgia , Humanos , Masculino , Obesidade/complicações , Obesidade/epidemiologia , Prostatectomia/efeitos adversos , Neoplasias da Próstata/patologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Resultado do Tratamento
19.
Sci Rep ; 12(1): 244, 2022 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-34997130

RESUMO

The quality of life (QoL) of men with optimal outcomes after robot-assisted radical prostatectomy (RARP) is largely unexplored. Thus we assessed meaningful changes of QoL measured with the EORTC QLQ-C30 24 months after RARP according to postsurgical Cancer of the Prostate Risk Assessment score (CAPRA-S) and pentafecta criteria. 2871 prostate cancer (PCa) patients with completed EORTC QLQ-C30 were stratified according to CAPRA-S, pentafecta (erectile function recovery, urinary continence recovery, biochemical-recurrence-free survival (BFS), negative surgical margins) and 90-day Clavien-Dindo-complications (CDC) ≤ 3a. Multivariable logistic regression analyses (LRM) aimed to predict improvement of EORTC QoL. Mean preoperative QoL values did not significantly differ between CAPRA-S low- (LR) vs. high-risk (HR, 75.7 vs. 75.2; p = 0.7) and pentafecta vs. non-pentafecta groups (75.6 vs. 75.2; p = 0.6). After RARP, stable QoL rates for CAPRA-S LR vs. HR and pentafecta were 30, 26 and 30%, respectively. Corresponding improved QoL rates were 44, 32 and 47%. In LRM, CAPRA-S and pentafecta criteria were independent predictors of improved QoL. We conclude that most favourable combined outcomes after RARP might confer stable or even improved QoL but up to one third of patients might experience deterioration. This warrants further investigation how to capture the underlying cause and to address and potentially solve these perceived negative effects despite successful RARP.


Assuntos
Prostatectomia , Neoplasias da Próstata/cirurgia , Qualidade de Vida , Procedimentos Cirúrgicos Robóticos , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Prostatectomia/efeitos adversos , Neoplasias da Próstata/patologia , Medição de Risco , Fatores de Risco , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
20.
Aging Male ; 25(1): 8-16, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34957914

RESUMO

OBJECTIVES: The aim of this study was to assess whether age ≥75 years impairs surgical, functional, and oncological outcomes after robot-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: Patients with prostate cancer (PCa) were stratified in ≥75(n = 669) vs. <70 years(n = 8,268). Multivariable cox regression analyses (MVA) tested for effect of senior age on erectile function-, urinary continence-recovery, biochemical recurrence (BCR), and metastatic progression (MP). RESULTS: RARP duration, blood loss, and 30d complication rates were similar between groups. For patients ≥75 vs. <70 years, rates of erectile function after 36 and urinary continence after 12 months were 27 vs. 56% (p < 0.001) and 85 vs. 86% (p = 0.99), respectively. Mean quality of life (QoL) score after 12 months improved in both groups (p = 0.9). At 48 months, BCR- and MP-free rates were 77 vs. 85% (p < 0.001) and 97 vs. 98% (p = 0.3), respectively. MVA confirmed the negative effect of senior age on erectile function but no significant effect on urinary continence, BCR or MP, before and after propensity score matching. CONCLUSION: Apart from erectile function, senior age has no significant effect on urinary continence recovery, BCR- or MP-free rates after RARP. Post-RARP QoL improved even in senior patients. Modern therapy of senior PCa patients should be based on individual counseling than just age.


Assuntos
Procedimentos Cirúrgicos Robóticos , Robótica , Idoso , Estudos de Viabilidade , Humanos , Masculino , Prostatectomia , Qualidade de Vida
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