20 results on '"Omar, Muhammad"'
Search Results
2. Benefits of Empiric Nutritional and Medical Therapy for Semen Parameters and Pregnancy and Live Birth Rates in Couples with Idiopathic Infertility: A Systematic Review and Meta-analysis.
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Omar, Muhammad Imran, Pal, Raj Prasenjit, Kelly, Brian D., Bruins, Harman Maxim, Yuan, Yuhong, Diemer, Thorsten, Krausz, Csilla, Tournaye, Herman, Kopa, Zsolt, Jungwirth, Andreas, and Minhas, Suks
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CHILDBIRTH , *DIET therapy , *BIRTH rate , *META-analysis , *SEMEN - Abstract
Abstract Context Empiric use of medical and nutritional supplements to improve semen parameters and pregnancy rates in couples with idiopathic infertility has reached global proportions, although the evidence base for their use in this setting is controversial. Objective We systematically reviewed evidence comparing the benefits of nutritional and medical therapy on pregnancy rates and semen parameters in men with idiopathic infertility. Evidence acquisition A literature search was performed using MEDLINE, Embase, LILACS, and the Cochrane Library (searched from January 1, 1990 to September 19, 2017). using the methods detailed in the Cochrane Handbook. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess the certainty of evidence. Evidence synthesis The literature search identified 5663 citations, and after screening of abstracts and full texts, 61 studies (59 randomised controlled trials and two nonrandomised comparative studies) were included. Pooled results demonstrated that pentoxyfylline, coenzyme Q10, L-carnitine, follicle-stimulating hormone, tamoxifen, and kallikrein all resulted in improvements in semen parameters. Individual studies identified several other medical and nutritional therapies that improved semen parameters, but data were limited to individual studies with inherent methodological flaws. There were limited data available on live birth and pregnancy rates for all interventions. The GRADE certainty of evidence for all outcomes was very low mainly owing to methodological flaws and inconsistencies in study design. Some outcomes were also downgraded owing to imprecision of results. Conclusions There is some evidence that empiric medical and nutritional supplements may improve semen parameters. There is very limited evidence that empiric therapy leads to better live birth rates, spontaneous pregnancy, or pregnancy following assisted-reproductive techniques. However, the findings should be interpreted with caution as there were some methodological flaws, as a number of studies were judged to be either at high or unclear risk of bias for many domains. Patient summary This review identified several medical and nutritional treatments, such as pentoxyfylline, coenzyme Q10, L-carnitine, follicle-stimulating hormone, tamoxifen, and kallikrein, that appear to improve semen parameters. However, there are limited data suggesting improvements in pregnancy and live birth rates. The lack of evidence can be attributed to methodological flaws in studies and the low number of pregnancies reported. Take Home Message This systematic review indicates that medical treatment and nutritional supplementation may improve male fertility. There is some evidence that empiric therapy may lead to improved rates of live birth, spontaneous pregnancy, and pregnancy following assisted reproductive techniques. [ABSTRACT FROM AUTHOR]
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- 2019
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3. Key Steps in Conducting Systematic Reviews for Underpinning Clinical Practice Guidelines: Methodology of the European Association of Urology.
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Knoll, Thomas, Omar, Muhammad Imran, Maclennan, Steven, Hernández, Virginia, Canfield, Steven, Yuan, Yuhong, Bruins, Max, Marconi, Lorenzo, Van Poppel, Hein, N’Dow, James, and Sylvester, Richard
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SYSTEMATIC reviews , *META-analysis , *MEDICAL decision making , *RANDOMIZED controlled trials , *UROLOGY , *SOCIETIES - Abstract
Context The findings of systematic reviews (SRs) and meta-analyses (MAs) are used for clinical decision making. The European Association of Urology has committed increasing resources into the development of high quality clinical guidelines based on such SRs and MAs. Objective In this paper, we have summarised the process of conducting SRs for underpinning clinical practice guidelines under the auspices of the European Association of Urology Guidelines Office. Evidence acquisition The process involves explicit methods and the findings should be reproducible. When conducting a SR, the essential first step is to formulate a clear and answerable research question. An extensive literature search lays the foundation for evidence synthesis. Data are extracted independently by two reviewers and any disagreements are resolved by discussion or arbitration by a third reviewer. Evidence synthesis In SRs, data for particular outcomes in individual randomised controlled trials may be combined statistically in a meta-analysis to increase power when the studies are similar enough. Biases in studies included in a SR/MA can lead to either an over estimation or an under estimation of true intervention effect size, resulting in heterogeneity in outcome between studies. A number of different tools are available such as Cochrane Risk of Bias assessment tool for randomised controlled trials. In circumstances where there is too much heterogeneity, or when a review has included nonrandomised comparative studies, it is more appropriate to conduct a narrative synthesis . The GRADE tool for assessing quality of evidence strives to be a structured and transparent system, which can be applied to all evidence, regardless of quality. A SR not only identifies, evaluates, and summarises the best available evidence, but also the gaps to be targeted by future studies. Conclusions SRs and MAs are integral in developing sound clinical practice guidelines and recommendations. Patient summary Clinical practice guidelines should be evidence based, and systematic reviews and meta-analyses are essential in their production. We have discussed the key steps of conducting systematic reviews and meta-analyses in this paper. [ABSTRACT FROM AUTHOR]
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- 2018
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4. Clinical Characterization of Patients Diagnosed with Prostate Cancer and Undergoing Conservative Management: A PIONEER Analysis Based on Big Data.
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Gandaglia, Giorgio, Pellegrino, Francesco, Golozar, Asieh, De Meulder, Bertrand, Abbott, Thomas, Achtman, Ariel, Imran Omar, Muhammad, Alshammari, Thamir, Areia, Carlos, Asiimwe, Alex, Beyer, Katharina, Bjartell, Anders, Campi, Riccardo, Cornford, Philip, Falconer, Thomas, Feng, Qi, Gong, Mengchun, Herrera, Ronald, Hughes, Nigel, and Hulsen, Tim
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PROSTATE cancer , *PROSTATE cancer patients , *EMERGENCY room visits , *BIG data , *THERAPEUTICS , *TYPE 2 diabetes - Abstract
Up to 25% of prostate cancer (PCa) patients managed conservatively experienced hospitalization and emergency department visits within 12 mo after diagnosis; 6% experienced PCa-related symptomatic progression. The probabilities of receiving therapies for PCa decreased according to the time elapsed after the diagnosis. Conservative management is an option for prostate cancer (PCa) patients either with the objective of delaying or even avoiding curative therapy, or to wait until palliative treatment is needed. PIONEER, funded by the European Commission Innovative Medicines Initiative, aims at improving PCa care across Europe through the application of big data analytics. To describe the clinical characteristics and long-term outcomes of PCa patients on conservative management by using an international large network of real-world data. From an initial cohort of >100 000 000 adult individuals included in eight databases evaluated during a virtual study-a-thon hosted by PIONEER, we identified newly diagnosed PCa cases (n = 527 311). Among those, we selected patients who did not receive curative or palliative treatment within 6 mo from diagnosis (n = 123 146). Patient and disease characteristics were reported. The number of patients who experienced the main study outcomes was quantified for each stratum and the overall cohort. Kaplan-Meier analyses were used to estimate the distribution of time to event data. The most common comorbidities were hypertension (35–73%), obesity (9.2–54%), and type 2 diabetes (11–28%). The rate of PCa-related symptomatic progression ranged between 2.6% and 6.2%. Hospitalization (12–25%) and emergency department visits (10–14%) were common events during the 1st year of follow-up. The probability of being free from both palliative and curative treatments decreased during follow-up. Limitations include a lack of information on patients and disease characteristics and on treatment intent. Our results allow us to better understand the current landscape of patients with PCa managed with conservative treatment. PIONEER offers a unique opportunity to characterize the baseline features and outcomes of PCa patients managed conservatively using real-world data. Up to 25% of men with prostate cancer (PCa) managed conservatively experienced hospitalization and emergency department visits within the 1st year after diagnosis; 6% experienced PCa-related symptoms. The probability of receiving therapies for PCa decreased according to time elapsed after the diagnosis. [ABSTRACT FROM AUTHOR]
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- 2024
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5. Reply to Qingpeng Xie and Dianqiu Shen's Letter to the Editor re: Bhavan P. Rai, José Luis Dominguez Escrig, Luís Vale, et al. Systematic Review of the Incidence of and Risk Factors for Urothelial Cancers and Renal Cell Carcinoma Among Patients with Haematuria. Eur Urol 2022;82:182–92
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Prasad Rai, Bhavan, Violette, Philippe D., and Imran Omar, Muhammad
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TRANSITIONAL cell carcinoma , *RENAL cell carcinoma - Published
- 2024
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6. What Are the Short-term Benefits and Potential Harms of Therapeutic Modalities for the Management of Overactive Bladder Syndrome in Women? A Review of Evidence Under the Auspices of the European Association of Urology, Female Non-neurogenic Lower Urinary Tract Symptoms Guidelines Panel
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Farag, Fawzy, Sakalis, Vasileios I., Arteaga, Serenella Monagas, Sihra, Néha, Karavitakis, Markos, Arlandis, Salvador, Bø, Kari, Cobussen-Boekhorst, Hanny, Costantini, Elisabetta, de Heide, Monica, Groen, Jan, Peyronnet, Benoit, Phé, Veronique, van Poelgeest-Pomfret, Mary-Lynne, van den Bos, Tine W.L., van der Vaart, Huub, Harding, Christopher K., Carmela Lapitan, Marie, Imran Omar, Muhammad, and Nambiar, Arjun K.
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OVERACTIVE bladder , *RETENTION of urine , *URINARY tract infections , *NEURAL stimulation , *URINARY urge incontinence , *SACRAL nerves , *TREATMENT effectiveness - Abstract
Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation. The choice of therapies should be guided by individual patient factors. Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions , and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Management of Urinary Retention in Patients with Benign Prostatic Obstruction: A Systematic Review and Meta-analysis.
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Karavitakis, Markos, Kyriazis, Iason, Omar, Muhammad Imran, Gravas, Stavros, Cornu, Jean-Nicolas, Drake, Marcus J., Gacci, Mauro, Gratzke, Christian, Herrmann, Thomas R.W., Madersbacher, Stephan, Rieken, Malte, Speakman, Mark J., Tikkinen, Kari A.O., Yuan, Yuhong, and Mamoulakis, Charalampos
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META-analysis , *RETENTION of urine , *CLINICAL trial registries , *RANDOMIZED controlled trials , *INTERNATIONAL organization , *URINARY organs - Abstract
Abstract Context Practice patterns for the management of urinary retention (UR) secondary to benign prostatic obstruction (BPO; UR/BPO) vary widely and remain unstandardized. Objective To review the evidence for managing patients with UR/BPO with pharmacological and nonpharmacological treatments included in the European Association of Urology guidelines on non-neurogenic male lower urinary tract symptoms. Evidence acquisition Search was conducted up to April 22, 2018, using CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform. This systematic review included randomized controlled trials (RCTs) and prospective comparative studies. Methods as detailed in the Cochrane handbook were followed. Certainty of evidence (CoE) was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Evidence synthesis Literature search identified 2074 citations. Twenty-one studies were included (qualitative synthesis). The evidence for managing patients with UR/BPO with pharmacological or nonpharmacological treatments is limited. CoE for most outcomes was low/very low. Only α1-blockers (alfuzosin and tamsulosin) have been evaluated in more than one RCT. Pooled results indicated that α1-blockers provided significantly higher rates of successful trial without catheter compared with placebo [alfuzosin: 322/540 (60%) vs 156/400 (39%) (odds ratio {OR} 2.28, 95% confidence interval {CI} 1.55 to 3.36; participants = 940; studies = 7; I 2 = 41%; low CoE); tamsulosin: 75/158 (47%) vs 40/139 (29%) (OR 2.40, 95% CI 1.29 to 4.45; participants = 297; studies = 3; I 2 = 30%; low CoE)] with rare adverse events. Similar rates were achieved with tamsulosin or alfuzosin [51/87 (59%) vs 45/84 (54%) (OR 1.28, 95% CI 0.68 to 2.41; participants = 171; studies = 2; I 2 = 0%; very low CoE)]. Nonpharmacological treatments have been evaluated in RCTs/prospective comparative studies only sporadically. Conclusions There is some evidence that usage of α1-blockers (alfuzosin and tamsulosin) may improve resolution of UR/BPO. As most nonpharmacological treatments have not been evaluated in patients with UR/BPO, the evidence is inconclusive about their benefits and harms. Patient summary There is some evidence that alfuzosin and tamsulosin may increase the rates of successful trial without catheter, but little or no evidence on various nonpharmacological treatment options for managing patients with urinary retention secondary to benign prostatic obstruction. Take Home Message Alfuzosin and tamsulosin appear to provide higher rates of successful trial without catheter. Most nonpharmacological treatment options have not been evaluated in patients with urinary retention secondary to benign prostatic obstruction. Consequently, the evidence is inconclusive regarding the efficacy of nonpharmacological interventions for the management of urinary retention secondary to benign prostatic obstruction. [ABSTRACT FROM AUTHOR]
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- 2019
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8. Reply to Badar M. Mian. Prostate Biopsy: Hyperbole and Misrepresentation Versus Scientific Evidence and Equipoise. Eur Urol. 2024;85:99–100.
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Pilatz, Adrian, MacLennan, Steven, van den Bergh, Roderick C.N., Veeratterapillay, Rajan, Imran Omar, Muhammad, Yuan, Yuhong, Cornford, Phillip, and Bonkat, Gernot
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PROSTATE biopsy , *HYPERBOLE - Published
- 2024
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9. Systematic Review of the Incidence of and Risk Factors for Urothelial Cancers and Renal Cell Carcinoma Among Patients with Haematuria.
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Rai, Bhavan P., Luis Dominguez Escrig, José, Vale, Luís, Kuusk, Teele, Capoun, Otakar, Soukup, Viktor, Bruins, Harman M., Yuan, Yuhong, Violette, Philippe D., Santesso, Nancy, van Rhijn, Bas W.G., Hugh Mostafid, A., and Imran Omar, Muhammad
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TRANSITIONAL cell carcinoma , *RENAL cell carcinoma , *HEMATURIA , *BLADDER cancer - Abstract
Male gender and smoking history are risk factors for cancer in haematuria. The commonest cancer among patients with haematuria is bladder cancer. The incidence of renal cell carcinoma and upper tract urothelial carcinoma among patients with nonvisible haematuria is low. The review provides a reference on investigation of haematuria for policy-making by organisations. The current impact of haematuria investigations on health care organisations is significant. There is currently no consensus on how to investigate patients with haematuria. To evaluate the incidence of bladder cancer, upper tract urothelial carcinoma (UTUC), and renal cell carcinoma (RCC) among patients undergoing investigation for haematuria and identify any risk factors for bladder cancer, UTUC, and RCC (BUR). Medline, Embase, and Cochrane controlled trials databases and ClinicalTrials.gov were searched for all relevant publications from January 1, 2000 to June 2021 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Prospective, retrospective, and cross-sectional studies with a minimum population of 50 patients with haematuria were considered for the review. A total of 44 studies were included. The total number of participants was 229 701. The pooled incidence rate for urothelial bladder cancer was 17% (95% confidence interval [CI] 14–20%) for visible haematuria (VH) and 3.3% (95% CI 2.45–4.3%) for nonvisible haematuria (NVH). The pooled incidence rate for RCC was 2% (95% CI 1–2%) for VH and 0.58% (95% CI 0.42–0.77%) for NVH. The pooled incidence rate for UTUC was 0.75% (95% CI 0.4–1.2%) for VH and 0.17% (95% CI 0.081–0.299%) for NVH. On sensitivity analysis, the proportions of males (risk ratio [RR] 1.14, 95% CI 1.10–1.17 for VH; 1.54, 95% CI 1.34–1.78 for NVH; p < 0.00001; moderate certainty evidence) and individuals with a smoking history (RR 1.41, 95% CI 1.24–1.61 for VH; 1.53, 95% CI 1.36–1.72 for NVH; p < 0.00001; moderate certainty evidence) appeared to be higher in BUR than in non-BUR groups. Male gender and smoking history are risk factors for BUR cancer in haematuria, with bladder cancer being the commonest cancer. The incidence of RCC and UTUC in NVH is low. The review serves as a reference standard for future policy-making on investigation of haematuria by global organisations. Our review shows that male gender and smoking history are risk factors for cancers of the bladder, kidney, and ureter. The review also provides information on the proportion of patients who have cancer when they have blood in their urine (haematuria) and will allow policy-makers to decide on the most appropriate method for investigating haematuria in patients. [ABSTRACT FROM AUTHOR]
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- 2022
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10. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence.
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Nambiar, Arjun K., Arlandis, Salvador, Bø, Kari, Cobussen-Boekhorst, Hanny, Costantini, Elisabetta, de Heide, Monica, Farag, Fawzy, Groen, Jan, Karavitakis, Markos, Lapitan, Marie Carmela, Manso, Margarida, Arteaga, Serenella Monagas, Riogh, Aisling Nic An, O'Connor, Eabhann, Omar, Muhammad Imran, Peyronnet, Benoit, Phé, Veronique, Sakalis, Vasileios I., Sihra, Néha, and Tzelves, Lazaros
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Female lower urinary tract dysfunction is a common reason for women to seek medical attention. Health care providers should endeavour to evaluate and manage these patients on the basis of the best available evidence and recommendations. Female lower urinary tract symptoms (LUTS) are a common presentation in urological practice. Thus far, only a limited number of female LUTS conditions have been included in the European Association of Urology (EAU) guidelines compendium. The new non-neurogenic female LUTS guideline expands the remit to include these symptoms and conditions. To summarise the diagnostic section of the non-neurogenic female LUTS guideline and the management of female overactive bladder (OAB), stress urinary incontinence (SUI), and mixed urinary incontinence (MUI). New literature searches were carried out in September 2021 and evidence synthesis was conducted using the modified GRADE criteria as outlined for all EAU guidelines. A new systematic review (SR) on OAB was carried out by the panel for the purposes of this guideline. The important considerations for informing guideline recommendations are presented, along with a summary of all the guideline recommendations. Non-neurogenic female LUTS are an important cause of urological dysfunction. Initial evaluation, diagnosis, and management should be carried out in a structured and logical fashion based on the best available evidence. This guideline serves to present this evidence to health care providers in an easily accessible and digestible format. This report summarises the main recommendations from the European Association of Urology guideline on symptoms and diseases of the female lower urinary tract (bladder and urethra) not associated with neurological disease. We cover recommendations related to diagnosis of these conditions, as well as the treatment of overactive bladder, stress urinary incontinence, and mixed urinary incontinence. [ABSTRACT FROM AUTHOR]
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- 2022
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11. European Association of Urology Guidelines on the Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 2: Underactive Bladder, Bladder Outlet Obstruction, and Nocturia.
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Arlandis, Salvador, Bø, Kari, Cobussen-Boekhorst, Hanny, Costantini, Elisabetta, de Heide, Monica, Farag, Fawzy, Groen, Jan, Karavitakis, Markos, Lapitan, Marie Carmela, Manso, Margarida, Arteaga, Serenella Monagas, Nambiar, Arjun K., Riogh, Aisling Nic An, O'Connor, Eabhann, Omar, Muhammad Imran, Peyronnet, Benoit, Phé, Veronique, Sakalis, Vasileios I., Sihra, Néha, and Tzelves, Lazaros
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Female lower urinary tract symptoms are a common reason for women to seek medical attention. Underactive bladder, bladder outlet obstruction, and nocturia are some of the underlying conditions causing these symptoms. Health care providers should endeavour to evaluate and manage these patients on the basis of the best available evidence and guideline recommendations. Female lower urinary tract symptoms (LUTS) are a common presentation in urological practice. Thus far, only a limited number of female LUTS conditions have been included in the European Association of Urology (EAU) guidelines compendium. The new non-neurogenic female LUTS guidelines expand the remit to include these symptoms and conditions. To summarise the management of underactive bladder (UAB), bladder outlet obstruction (BOO), and nocturia in females. The literature search was updated in September 2021 and evidence synthesis was conducted using modified GRADE approach as outlined for all EAU guidelines. A new systematic review on BOO was carried out by the panel for purposes of this guideline. The important considerations for informing guideline recommendations are presented, along with a summary of all the guideline recommendations. Non-neurogenic female LUTS are an important presentation of urological dysfunction. Initial evaluation, diagnosis, and management should be carried out in a structured and logical fashion on the basis of the best available evidence. This guideline serves to present this evidence to practising urologists and other health care providers in an easily accessible and digestible format. This report summarises the main recommendations from the European Association of Urology guideline on symptoms and diseases of the female lower urinary tract (bladder and urethra) not associated with neurological disease. We cover recommendations related to the treatment of underactive bladder, obstruction of the bladder outlet, and nighttime urination. [ABSTRACT FROM AUTHOR]
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- 2022
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12. Updating and Integrating Core Outcome Sets for Localised, Locally Advanced, Metastatic, and Nonmetastatic Castration-resistant Prostate Cancer: An Update from the PIONEER Consortium.
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Beyer, Katharina, Moris, Lisa, Lardas, Michael, Omar, Muhammad Imran, Healey, Jemma, Tripathee, Sheela, Gandaglia, Giorgio, Venderbos, Lionne D.F., Vradi, Eleni, van den Broeck, Thomas, Willemse, Peter-Paul, Antunes-Lopes, Tiago, Pacheco-Figueiredo, Luis, Monagas, Serenella, Esperto, Francesco, Flaherty, Stephen, Devecseri, Zsuzsanna, Lam, Thomas B.L., Williamson, Paula R., and Heer, Rakesh
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CASTRATION-resistant prostate cancer , *PROSTATE cancer , *METASTASIS , *MEDICAL research - Abstract
The PIONEER Consortium has updated and integrated existing core outcome sets for prostate cancer for the different stages of the disease, assessed their applicability, and developed standardised definitions of prioritised outcomes for use in research settings and clinical practice. Harmonisation of outcome reporting and definitions for clinical trials and routine patient records can enable health care systems to provide more efficient outcome-driven and patient-centred interventions. We report on the work of the PIONEER Consortium in this context for prostate cancer (PCa). To update and integrate existing core outcome sets (COS) for PCa for the different stages of the disease, assess their applicability, and develop standardised definitions of prioritised outcomes. We followed a four-stage process involving: (1) systematic reviews; (2) qualitative interviews; (3) expert group meetings to agree standardised terminologies; and (4) recommendations for the most appropriate definitions of clinician-reported outcomes. Following four systematic reviews, a multinational interview study, and expert group consensus meetings, we defined the most clinically suitable definitions for (1) COS for localised and locally advanced PCa and (2) COS for metastatic and nonmetastatic castration-resistant PCa. No new outcomes were identified in our COS for localised and locally advanced PCa. For our COS for metastatic and nonmetastatic castration-resistant PCa, nine new core outcomes were identified. These are the first COS for PCa for which the definitions of prioritised outcomes have been surveyed in a systematic, transparent, and replicable way. This is also the first time that outcome definitions across all prostate cancer COS have been agreed on by a multidisciplinary expert group and recommended for use in research and clinical practice. To limit heterogeneity across research, these COS should be recommended for future effectiveness trials, systematic reviews, guidelines and clinical practice of localised and metastatic PCa. Patient outcomes after treatment for prostate cancer (PCa) are difficult to compare because of variability. To allow better use of data from patients with PCa, the PIONEER Consortium has standardised and recommended outcomes (and their definitions) that should be collected as a minimum in all future studies. [ABSTRACT FROM AUTHOR]
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- 2022
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13. European Association of Urology Position Paper on the Prevention of Infectious Complications Following Prostate Biopsy.
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Pilatz, Adrian, Veeratterapillay, Rajan, Dimitropoulos, Konstantinos, Omar, Muhammad Imran, Pradere, Benjamin, Yuan, Yuhong, Cai, Tommaso, Mezei, Tunde, Devlies, Wout, Bruyère, Franck, Bartoletti, Riccardo, Köves, Bela, Geerlings, Suzanne, Schubert, Sören, Grummet, Jeremy, Mottet, Nicolas, Wagenlehner, Florian, and Bonkat, Gernot
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PROSTATE biopsy , *ENDORECTAL ultrasonography , *UROLOGY , *FLUOROQUINOLONES , *POVIDONE-iodine , *PREVENTIVE medicine - Abstract
The transperineal approach is preferred to reduce prostate biopsy (PB)-related infections. Fluoroquinolones are suspended for prophylaxis of PB in the European Union; therefore, alternative antibiotics based on local resistance, or targeted prophylaxis, in conjunction with povidone-iodine rectal preparation are recommended for transrectal PB. [ABSTRACT FROM AUTHOR]
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- 2021
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14. Benefits and Risks of Primary Treatments for High-risk Localized and Locally Advanced Prostate Cancer: An International Multidisciplinary Systematic Review.
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Moris, Lisa, Cumberbatch, Marcus G., Van den Broeck, Thomas, Gandaglia, Giorgio, Fossati, Nicola, Kelly, Brian, Pal, Raj, Briers, Erik, Cornford, Philip, De Santis, Maria, Fanti, Stefano, Gillessen, Silke, Grummet, Jeremy P., Henry, Ann M., Lam, Thomas B.L., Lardas, Michael, Liew, Matthew, Mason, Malcolm D., Omar, Muhammad Imran, and Rouvière, Olivier
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META-analysis , *PROSTATE cancer , *GLEASON grading system , *PROSTATE-specific antigen , *CLINICAL trials , *RANDOMIZED controlled trials - Abstract
The optimal treatment for men with high-risk localized or locally advanced prostate cancer (PCa) remains unknown. To perform a systematic review of the existing literature on the effectiveness of the different primary treatment modalities for high-risk localized and locally advanced PCa. The primary oncological outcome is the development of distant metastases at ≥5 yr of follow-up. Secondary oncological outcomes are PCa-specific mortality, overall mortality, biochemical recurrence, and need for salvage treatment with ≥5 yr of follow-up. Nononcological outcomes are quality of life (QoL), functional outcomes, and treatment-related side effects reported. Medline, Medline In-Process, Embase, and the Cochrane Central Register of Randomized Controlled Trials were searched. All comparative (randomized and nonrandomized) studies published between January 2000 and May 2019 with at least 50 participants in each arm were included. Studies reporting on high-risk localized PCa (International Society of Urologic Pathologists [ISUP] grade 4–5 [Gleason score {GS} 8–10] or prostate-specific antigen [PSA] >20 ng/ml or ≥ cT2c) and/or locally advanced PCa (any PSA, cT3–4 or cN+, any ISUP grade/GS) or where subanalyses were performed on either group were included. The following primary local treatments were mandated: radical prostatectomy (RP), external beam radiotherapy (EBRT) (≥64 Gy), brachytherapy (BT), or multimodality treatment combining any of the local treatments above (±any systemic treatment). Risk of bias (RoB) and confounding factors were assessed for each study. A narrative synthesis was performed. Overall, 90 studies met the inclusion criteria. RoB and confounding factors revealed high RoB for selection, performance, and detection bias, and low RoB for correction of initial PSA and biopsy GS. When comparing RP with EBRT, retrospective series suggested an advantage for RP, although with a low level of evidence. Both RT and RP should be seen as part of a multimodal treatment plan with possible addition of (postoperative) RT and/or androgen deprivation therapy (ADT), respectively. High levels of evidence exist for EBRT treatment, with several randomized clinical trials showing superior outcome for adding long-term ADT or BT to EBRT. No clear cutoff can be proposed for RT dose, but higher RT doses by means of dose escalation schemes result in an improved biochemical control. Twenty studies reported data on QoL, with RP resulting mainly in genitourinary toxicity and sexual dysfunction, and EBRT in bowel problems. Based on the results of this systematic review, both RP as part of multimodal treatment and EBRT + long-term ADT can be recommended as primary treatment in high-risk and locally advanced PCa. For high-risk PCa, EBRT + BT can also be offered despite more grade 3 toxicity. Interestingly, for selected patients, for example, those with higher comorbidity, a shorter duration of ADT might be an option. For locally advanced PCa, EBRT + BT shows promising result but still needs further validation. In this setting, it is important that patients are aware that the offered therapy will most likely be in the context a multimodality treatment plan. In particular, if radiation is used, the combination of local with systemic treatment provides the best outcome, provided the patient is fit enough to receive both. Until the results of the SPCG15 trial are known, the optimal local treatment remains a matter of debate. Patients should at all times be fully informed about all available options, and the likelihood of a multimodal approach including the potential side effects of both local and systemic treatment. We reviewed the literature to see whether the evidence from clinical studies would tell us the best way of curing men with aggressive prostate cancer that had not spread to other parts of the body such as lymph glands or bones. Based on the results of this systematic review, there is good evidence that both surgery and radiation therapy are good treatment options, in terms of prolonging life and preserving quality of life, provided they are combined with other treatments. In the case of surgery this means including radiotherapy (RT), and in the case of RT this means either hormonal therapy or combined RT and brachytherapy. High-risk and locally advanced prostate cancer (PCa) patients are likely to undergo multimodality treatment. Patients should at all times be fully informed about all available options and the likelihood of a multimodal approach, including the potential side effects of both local and systemic treatment. For high-risk localized and locally advanced PCa, both radical prostatectomy as part as multimodal therapy and external beam radiotherapy (EBRT) + long-term androgen deprivation therapy (ADT) can be recommended as primary treatment. For high-risk localized PCa, EBRT + BT can also be offered despite a less favorable toxicity profile. In selected high-risk PCa patients, a shorter duration of ADT might be considered. Until the results of the SPCG15 trial are known, the optimal local treatment remains a matter of debate. [ABSTRACT FROM AUTHOR]
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- 2020
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15. Study Protocol for the DETECTIVE Study: An International Collaborative Study To Develop Consensus Statements for Deferred Treatment with Curative Intent for Localised Prostate Cancer.
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Lam, Thomas B.L., MacLennan, Steven, Plass, Karin, Willemse, Peter-Paul M., Mason, Malcolm D., Cornford, Philip, Donaldson, James, Davis, Niall F., Dell'Oglio, Paolo, Fankhauser, Christian, Grivas, Nikos, Ingels, Alexandre, Lardas, Michael, Liew, Matthew, Pang, Karl H., Paterson, Catherine, Omar, Muhammad I., Zattoni, Fabio, Buddingh, Karel T., and Van den Broeck, Thomas
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ONCOLOGISTS , *PROSTATE cancer , *DETECTIVES , *MEDICAL personnel , *CONSENSUS (Social sciences) - Published
- 2019
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16. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies.
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Marconi, Lorenzo, MacLennan, Steven, Lam, Thomas B. L., Canfield, Steven E., Yuhong Yuan, Omar, Muhammad Imran, N'Dow, James, Sylvester, Richard, Derweesh, Ithaar H., Mir, Maria C., and Autorino, Riccardo
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NEPHRECTOMY , *KIDNEY tumors , *COMORBIDITY , *DECISION making in clinical medicine , *TREATMENT effectiveness , *TUMOR treatment - Published
- 2017
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17. Systematic Review of Perioperative and Quality-of-life Outcomes Following Surgical Management of Localised Renal Cancer
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MacLennan, Steven, Imamura, Mari, Lapitan, Marie C., Omar, Muhammad Imran, Lam, Thomas B.L., Hilvano-Cabungcal, Ana M., Royle, Pam, Stewart, Fiona, MacLennan, Graeme, MacLennan, Sara J., Dahm, Philipp, Canfield, Steven E., McClinton, Sam, Griffiths, T.R. Leyshon, Ljungberg, Börje, and N’Dow, James
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CANCER treatment , *RENAL cell carcinoma , *SYSTEMATIC reviews , *QUALITY of life , *PERIOPERATIVE care , *BLOOD transfusion , *HEALTH outcome assessment , *NEPHRECTOMY - Abstract
Abstract: Context: For the treatment of localised renal cell carcinoma (RCC), uncertainties remain over the perioperative and quality-of-life (QoL) outcomes for the many different surgical techniques and approaches of nephrectomy. Controversy also remains on whether newer minimally invasive nephron-sparing interventions offer better QoL and perioperative outcomes, and whether adrenalectomy and lymphadenectomy should be performed simultaneously with nephrectomy. These non-oncological outcomes are important because they may have a considerable impact on localised RCC treatment decision making. Objective: To review systematically all the relevant published literature comparing perioperative and QoL outcomes of surgical management of localised RCC (T1–2N0M0). Evidence acquisition: Relevant databases including Medline, Embase, and the Cochrane Library were searched up to January 2012. Randomised controlled trials (RCTs) or quasi-randomised controlled trials, prospective observational studies with controls, retrospective matched-pair studies, and comparative studies from well-defined registries/databases were included. The outcome measures were QoL, analgesic requirement, length of hospital stay, time to normal activity level, surgical morbidity and complications, ischaemia time, renal function, blood loss, length of operation, need for blood transfusion, and perioperative mortality. The Cochrane risk of bias tool was used to assess RCTs, and an extended version was used to assess nonrandomised studies (NRSs). The quality of evidence was assessed using Grading of Recommendations, Assessment, Development, and Evaluation. Evidence synthesis: A total of 4580 abstracts and 380 full-text articles were assessed, and 29 studies met the inclusion criteria (7 RCTs and 22 NRSs). There were high risks of bias and low-quality evidence for studies meeting the inclusion criteria. There is good evidence indicating that partial nephrectomy results in better preservation of renal function and better QoL outcomes than radical nephrectomy regardless of technique or approach. Regarding radical nephrectomy, the laparoscopic approach has better perioperative outcomes than the open approach, and there is no evidence of a difference between the transperitoneal and retroperitoneal approaches. Alternatives to standard laparoscopic radical nephrectomy (LRN) such as hand-assisted, robot-assisted, or single-port techniques appear to have similar perioperative outcomes. There is no good evidence to suggest that minimally invasive procedures such as cryotherapy or radiofrequency ablation have superior perioperative or QoL outcomes to nephrectomy. Regarding concomitant lymphadenectomy during nephrectomy, there were low event rates for complications, and no definitive difference was observed. There was no evidence to base statements about concomitant ipsilateral adrenalectomy during nephrectomy. Conclusions: Partial nephrectomy results in significantly better preservation of renal function over radical nephrectomy. For tumours where partial nephrectomy is not technically feasible, there is no evidence that alternative procedures or techniques are better than LRN in terms of perioperative or QoL outcomes. In making treatment decisions, perioperative and QoL outcomes should be considered in conjunction with oncological outcomes. Overall, there was a paucity of data regarding QoL outcomes, and when reported, both QoL and perioperative outcomes were inconsistently defined, measured, or reported. The current evidence base has major limitations due to studies of low methodological quality marked by high risks of bias. [Copyright &y& Elsevier]
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- 2012
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18. Systematic Review of Oncological Outcomes Following Surgical Management of Localised Renal Cancer
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MacLennan, Steven, Imamura, Mari, Lapitan, Marie C., Omar, Muhammad Imran, Lam, Thomas B.L., Hilvano-Cabungcal, Ana M., Royle, Pam, Stewart, Fiona, MacLennan, Graeme, MacLennan, Sara J., Canfield, Steven E., McClinton, Sam, Griffiths, T.R. Leyshon, Ljungberg, Börje, and N’Dow, James
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RENAL cancer treatment , *HEALTH outcome assessment , *RENAL cell carcinoma , *LONGITUDINAL method , *RETROSPECTIVE studies , *METASTASIS , *SYSTEMATIC reviews - Abstract
Abstract: Context: Renal cell carcinoma (RCC) accounts for 2–3% of adult malignancies. There remain uncertainties over the oncological outcomes for the surgical management of localised RCC. Objective: Systematically review relevant literature comparing oncological outcomes of surgical management of localised RCC (T1–2N0M0). Evidence acquisition: Relevant databases including Medline, Embase, and the Cochrane Library were searched up to October 2010, and an updated scoping search was performed up to January 2012. Randomised controlled trials (RCTs) or quasi-RCTs, prospective observational studies with controls, retrospective matched-pair studies, and comparative studies from well-defined registries/databases were included. The main outcomes were overall survival, cancer-specific survival, recurrence, and metastases. The Cochrane risk of bias tool was used to assess RCTs, and an extended version was used to assess nonrandomised studies (NRSs). The quality of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Evidence synthesis: A total of 4580 abstracts and 389 full-text articles were assessed. Thirty-four studies met the inclusion criteria (6 RCTs and 28 NRSs). Meta-analyses were planned but were deemed inappropriate due to data heterogeneity. There were high risks of bias and low-quality evidence across the evidence base. Open radical nephrectomy and open partial nephrectomy showed similar cancer-specific and overall survival, but when both open and laparoscopic approaches are considered together, the evidence showed improved survival for partial nephrectomy for tumours ≤4cm. The overall evidence suggests either equivalent or better survival with partial nephrectomy. Laparoscopic radical nephrectomy offered equivalent survival to open radical nephrectomy, and all laparoscopic approaches achieved equivalent survival. Open and laparoscopic partial nephrectomy achieved equivalent survival. The issue of ipsilateral adrenalectomy or complete lymph node dissection with radical nephrectomy or partial nephrectomy remains unresolved. Conclusions: The evidence base suggests localised RCCs are best managed by nephron-sparing surgery where technically feasible. However, the current evidence base has significant limitations due to studies of low methodological quality marked by high risks of bias. [Copyright &y& Elsevier]
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- 2012
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19. Reply to Philipp Dahm, Vikram Narayan, and Jae Hung Jung's Letter to the Editor re: Richard J. Sylvester, Steven E. Canfield, Thomas B.L. Lam, et al. Conflict of Evidence: Resolving Discrepancies When Findings from Randomized Controlled Trials and Meta-analyses Disagree. Eur Urol 2017;71:811–9
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Lam, Thomas B.l., Sylvester, Richard J., Canfield, Steven E., Marconi, Lorenzo, Maclennan, Steven, Yuan, Yuhong, Omar, Muhammad Imran, and N'dow, James
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RANDOMIZED controlled trials , *META-analysis - Published
- 2017
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20. Corrigendum to “Systematic Review of Oncological Outcomes Following Surgical Management of Localised Renal Cancer” [Eur Urol 2012;61:972–93]
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MacLennan, Steven, Imamura, Mari, Lapitan, Marie C., Omar, Muhammad Imran, Lam, Thomas B.L., Hilvano-Cabungcal, Ana M., Royle, Pam, Stewart, Fiona, MacLennan, Graeme, MacLennan, Sara J., Canfield, Steven E., McClinton, Sam, Griffiths, T.R. Leyshon, Ljungberg, Börje, and N’Dow, James
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- 2012
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