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PURPOSE: This study assessed the efficacy, safety and durability outcomes of water vapor thermal therapy with Rezum in a real-world cohort of patients with lower urinary tract symptoms due to benign prostate obstruction. METHODS: Consecutive, unselected patients undergoing Rezum treatment between January 2014 and August 2022 were candidates for this pragmatic, observational, longitudinal, single-center cohort study. Pre- and perioperative data were descriptively summarized. The primary outcome was surgical efficacy, determined by International Prostate Symptom Score (IPSS), Quality of Life (QoL) Score, maximum urinary flow rate (Qmax), post-void residual (PVR) volume and prostate volume (PV) at baseline, 2 months, 6 months, 1 year, 2 years, and > 2 years. RESULTS: A total of 211 patients were enrolled for analysis. Overall, catheter removal was successful in 92.4% of patients after a median of 5 days. A preoperative catheter and the presence of a median lobe increased the risk of unsuccessful catheter removal. In total, 5.7% of patients were reoperated after a median of 407 days. Comparing baseline to the longest median follow-up, the postoperative IPSS decreased significantly by 65.7%, the QoL Score declined by 66.7% (both until a maximum median of 4.5 years) and Qmax improved by 66.7% (until 3.9 years). Post-void residual volume and PV were reduced by 85.7% (3.7 years) and 47% (4.0 years), respectively. Clavien-Dindo complication ≤ II occurred in 11.8%. CONCLUSION: Rezum is a safe minimally invasive treatment option in a real-world patient cohort with a beneficial improvement of micturition symptoms and voiding function during follow-up.
Subject(s)
Lower Urinary Tract Symptoms , Prostatic Hyperplasia , Male , Humans , Steam , Quality of Life , Treatment Outcome , Cohort Studies , Lower Urinary Tract Symptoms/etiology , Lower Urinary Tract Symptoms/therapy , Prostatic Hyperplasia/surgeryABSTRACT
PURPOSE: The administration of antimicrobial prophylaxis for postoperative urinary tract infections following transurethral resection of bladder tumors is controversial. We aimed to systematically review evidence on the potential effect of antimicrobial prophylaxis on postoperative urinary tract infections and asymptomatic bacteriuria. MATERIALS AND METHODS: We conducted a systematic search in Embase®, Medline® and the Cochrane Central Register of Controlled Trials. Randomized controlled trials and nonrandomized controlled trials assessing the effect of any form of antimicrobial prophylaxis in patients with transurethral resection of bladder tumors on postoperative urinary tract infections or asymptomatic bacteriuria were included. Risk of bias was assessed using RoB 2.0 or the Newcastle-Ottawa Scale. Fixed and random effects meta-analyses were conducted. As a potential basis for a scoping review, we exploratorily searched Medline for risk factors for urinary tract infections after transurethral resection of bladder tumors. The protocol was registered on PROSPERO (CRD42019131733). RESULTS: Of 986 screened publications, 7 studies with 1,725 participants were included; the reported effect sizes varied considerably. We found no significant effect of antimicrobial prophylaxis on urinary tract infections: the pooled odds ratio of the random effects model was 1.55 (95% CI 0.73-3.31). The random effects meta-analysis examining the effect of antimicrobial prophylaxis on asymptomatic bacteriuria showed an OR of 0.43 (0.18-1.04). Risk of bias was moderate. Our exploratory search identified 3 studies reporting age, preoperative pelvic radiation, preoperative hospital stay, duration of operation, tumor size, preoperative asymptomatic bacteriuria and pyuria as risk factors for urinary tract infections following transurethral resection of bladder tumors. CONCLUSIONS: We observed insufficient evidence supporting routine antimicrobial prophylaxis in patients undergoing transurethral resection of bladder tumors for the prevention of postoperative urinary tract infections; our findings may inform harmonization of international guidelines.
Subject(s)
Antibiotic Prophylaxis , Bacteriuria/prevention & control , Postoperative Complications/prevention & control , Urinary Bladder Neoplasms/surgery , Urinary Tract Infections/prevention & control , HumansABSTRACT
BACKGROUND: Tuberous Sclerosis Complex (TSC) is a genetic disorder, with renal manifestations like angiomyolipoma (AML) occurring in 70-80% of patients. AML usually cause more complications in TCS patients than in non-TSC patients. However, AML patients are not routinely investigated for TSC. Our aim was to retrospectively assess the correlation between radiologically diagnosed AML and TSC. METHODS: All patients were stratified into AML related vs. unrelated to TSC. Correlations were calculated to determine the association between age, AML, and TSC. RESULTS: Complete data were available for 521 patients with renal AML, in 7 of which the concurrent diagnosis of TSC was found. Younger age significantly positively correlated with the prevalence of TSC in AML patients (p < 0.01). 37 (7%) of the 521 patients were within the age-range of 18-40 years, in which TSC occurred in 6 cases, 4 (66.7%) of which presented with multiple, bilateral renal AML (p < 0.05), and 2 (33.3%) of which with a single, unilateral AML (p < 0.05). In patients with AML but without TSC, unilateral AML was found in 83.9% and bilateral AML in 16.1% (p < 0.05). Simple binary logistic regression analysis revealed bilateral AML (OR 33.0; 95% CI 3.2-344.0; p = 0.003) (but not unilateral AML (OR 0.09; 95% CI 0.01-0.88; p = 0.04)) to be a risk factor for TSC. CONCLUSIONS: The presence of bilateral AML in patients within the age-range of 18-40 years should raise suspicion for TSC as the underlying cause. Therefore, our advice is to refer patients with multiple bilateral renal AML for further investigations regarding TSC.
Subject(s)
Angiomyolipoma/etiology , Kidney Neoplasms/etiology , Tuberous Sclerosis/complications , Adult , Aged , Aged, 80 and over , Angiomyolipoma/diagnostic imaging , Correlation of Data , Female , Humans , Kidney Neoplasms/diagnostic imaging , Male , Middle Aged , Radiography , Retrospective Studies , Tuberous Sclerosis/diagnostic imaging , Young AdultABSTRACT
PURPOSE: Although photoselective laser vaporisation of the prostate (PVP) is a recognised alternative to transurethral resection in treating benign prostatic obstruction, there is limited data on the incidence and determinants of postoperative urinary tract infections (UTI). We assessed patients subjected to PVP, evaluating incidence and potential determinants of postoperative UTIs. MATERIALS AND METHODS: Consecutive patients undergoing PVP between April 2010 and August 2018 were candidates for this retrospective cohort study. The primary outcome measure was microbiologically confirmed postoperative UTI. We fitted uni- and multi-variable Cox models to identify potential risk factors. RESULTS: Among the 665 included patients, 20% developed postoperative UTIs. The overall incidence rate per 100 patient-days was 0.65 (95% confidence interval [CI] 0.55-0.77). Risk factors for postoperative UTIs were end-stage renal failure (adjusted hazard ratio [aHR] = 14.10, 95% CI 2.08-64.58; p = 0.001) and presence of at least one of the following factors in the 3 months preceding PVP: (i) placement of urinary catheter, (ii) bacteriuria, (iii) UTI, or (iv) antimicrobial treatment (composite aHR = 1.99, 95% CI 1.22-3.24; p < 0.001). There was no apparent association between choice or duration of antimicrobial prophylaxis and incident UTIs. CONCLUSIONS: Our analysis revealed a high incidence of UTIs after PVP and served to identify certain preoperative risk factors. Neither the choice of antimicrobial regimen nor its duration affected the incidence of UTIs. Prolonged antimicrobials proved to be disproportionately high, warranting further scrutiny in randomised controlled trials.
Subject(s)
Laser Therapy , Postoperative Complications/epidemiology , Prostatectomy/methods , Prostatic Hyperplasia/surgery , Urinary Tract Infections/epidemiology , Aged , Cohort Studies , Humans , Incidence , Laser Therapy/methods , Male , Retrospective Studies , Risk Assessment , Risk FactorsABSTRACT
Objective: The objective of this study is to investigate the incidence and risk factors for stone formation and recurrence in patients with neurogenic lower urinary tract dysfunction (NLUTD) in a real-world cohort. Materials and methods: A retrospective cohort study was conducted on all patients with NLUTD who underwent bladder stone treatment between 2010 and 2022. Univariate and multivariate Cox models were used to identify the potential risk factors for stone recurrence. Results: Among 114 patients included in the study, 30% experienced stone recurrence. The most common stone components were carbonate apatite phosphate and magnesium ammonium phosphate. The overall recurrence rate was 14 cases per 100 patient years. Neurogenic detrusor overactivity had the highest recurrence rate. Risk factors for stone recurrence in the multivariate analysis were intermittent and suprapubic catheterization, and recurrent urinary tract infection (rUTI). Conclusions: Patients experienced multiple bladder stone recurrences. Close monitoring of bladder pressure and UTI with restrictive catheter application may reduce the risk of stone recurrence.
ABSTRACT
Although tuberculosis (TB) ranks among the most frequent infectious diseases worldwide, one of its extrapulmonary (EP) manifestations, genitourinary (GU) TB, is often underestimated by urologists, particularly in areas such as Europe where TB is not endemic. The aim of this review is to give urologists a concise overview of GUTB as a supplement to the more comprehensive European Association of Urology 2023 update on urological infections guidelines. EPTB can develop in 16% of TB cases. GUTB accounts for 4.6% of EPTB and is often asymptomatic or nonspecific, so it can be confused with other urogenital diseases. GUTB can be highly destructive, leading to failure of urogenital organs. Diagnosis is via microbiological, molecular, and histological testing for urine, genital secretions, or genitourinary tissue, supported by imaging. A 6-mo combinational medical regimen is the first-line treatment for GUTB. However, surgical interventions are also frequently required for the treatment of GUTB complications. Therefore, it is important to keep GUTB in mind for differential diagnosis. PATIENT SUMMARY: We reviewed scientific studies on the occurrence, diagnosis, and treatment of tuberculosis in the genitourinary tract. Our aim is to raise awareness among urologists from countries where this disease does not occur frequently, as urogenital tuberculosis can occur without any symptoms or with unspecific symptoms that can be confused with other diseases.
Subject(s)
Tuberculosis, Urogenital , Tuberculosis , Urology , Humans , Urologists , Tuberculosis, Urogenital/therapy , Tuberculosis, Urogenital/surgery , Tuberculosis/diagnosis , Diagnosis, DifferentialABSTRACT
The blinded APPEAL trial is assessing the effectiveness of antimicrobial prophylaxis in preventing infections after shockwave lithotripsy for urinary stones. This large, pragmatic, international trial will provide trustworthy evidence to inform guidelines and influence global practices.
ABSTRACT
BACKGROUND AND OBJECTIVE: Urological infections significantly impact the wellbeing and quality of life of individuals owing to their widespread occurrence and diverse clinical manifestations. The objective of the guidelines panel was to provide evidence-based guidance on the diagnosis, treatment, and prevention of urinary tract infections (UTIs) and male accessory-gland infections, while addressing crucial public health aspects related to infection control and antimicrobial stewardship. METHODS: For the 2024 guidelines on urological infections, new and relevant evidence was identified, collated, and appraised via a structured assessment of the literature. Databases searched included Medline, EMBASE, and the Cochrane Libraries. Recommendations within the guidelines were developed by the panel to prioritise clinically important care decisions. The strength of each recommendation was determined according to a balance between desirable and undesirable consequences of alternative management strategies, the quality of the evidence (including the certainty of estimates), and the nature and variability of patient values and preferences. KEY FINDINGS AND LIMITATIONS: Key recommendations emphasise the importance of a thorough medical history and physical examination for patients with urological infections. The guidelines stress the role of antimicrobial stewardship to combat the rising threat of antimicrobial resistance, providing recommendations for antibiotic selection, dosing, and duration on the basis of the latest evidence. CONCLUSIONS AND CLINICAL IMPLICATIONS: This overview of the 2024 EAU guidelines offers valuable insights into managing urological infections and are designed for effective integration into clinical practice. PATIENT SUMMARY: The European Association of Urology has issued an updated guideline on urological infections. The guidelines provide recommendations for diagnosis, treatment, and prevention, with a particular focus on minimising antibiotic use because of the increasing global threat of antimicrobial resistance.
Subject(s)
Urinary Tract Infections , Humans , Urinary Tract Infections/diagnosis , Urinary Tract Infections/drug therapy , Urinary Tract Infections/therapy , Anti-Bacterial Agents/therapeutic use , Urology/standards , Male , Antimicrobial Stewardship , EuropeABSTRACT
Medication-related osteonecrosis of the jaw (MRONJ) is a potentially preventable adverse side effect of mainly antiresorptive drugs. MRONJ is expected to become a growing clinical problem due to the aging population and the increasing number of patients requiring antiresorptive agents. Knowledge and awareness about MRONJ and elimination of the oral and dental risk factors before starting antiresorptive therapy (AR) are fundamental to reducing the incidence of MRONJ. In urology, ARs are used primarily in patients suffering from bone metastases due to prostate cancer and to prevent cancer-treatment-induced bone loss (CTIBL) in prostate cancer patients receiving endocrine therapy. This postal survey aimed to evaluate disease-related knowledge and awareness about implementing oral examinations for patients starting AR among Swiss, German, and Austrian urologists. A total of 176 urologists returned the completed questionnaire, yielding a response rate of 11.7%. Of the respondents, 44.9% (n = 79) and 24.4% (n = 43) stated that they give more than five first-time prescriptions of denosumab and of intravenous or oral bisphosphonates per year, respectively. Only 14.8% (n = 26) of the participating urologists had never encountered MRONJ cases related to BPs. Of the participants, 89.8% (n = 158) had implemented referrals to dentists for oral examination before initiating AR. The mean percentage of correct answers regarding the knowledge about MRONJ was 70.9% ± 11.2%. In contrast to previous surveys on MRONJ among physicians, this study showed that the participating urologists were sufficiently informed about MRONJ, as reflected by the high number of participants implementing preventive dental screenings.
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Purpose: Although robot-assisted laparoscopic ureter reimplantation (RALUR) is a recognized alternative to open and laparoscopic ureter reimplantation in treating distal ureteral obstruction, there are limited data on long-term efficacy and safety outcomes of non-antireflux RALUR. We assessed patients undergoing RALUR, evaluating operative, functional, and safety determinants. Materials and Methods: All consecutive patients undergoing non-antireflux RALUR between April 2015 and January 2020 were included in this retrospective cohort study. The primary outcome endpoint was recurrent distal ureteral obstruction. Results: Mean follow-up was 41.3 months (95% confidence interval, 33.3-49.2; range 2-82). Among the 26 included patients, none developed recurrent distal ureteral obstruction. Kidney function in terms of serum creatinine level (72.0 µmol/L vs 71.0 µmol/L, p = 0.988) and glomerular filtration rate (92.0 mL/min vs 91.0 mL/min, p = 0.831) was stable between the preoperative period and the last follow-up. Renal pelvis dilatation decreased significantly postoperatively, from grade 2 to grade 0 (p < 0.001). Most patients (73.1%) remained free from any clinical symptoms of reflux during the follow-up. No recurring urinary tract infections were reported. The rate of postoperative complications (Clavien-Dindo grade ≥II) was 23.1%. All complications resolved without sequelae. Conclusions: Non-antireflux RALUR appears to be safe and effective in the management of distal ureteral obstruction. There was no recurrent ureteral obstruction after RALUR in our cohort during a mean follow-up of more than 3 years. Non-antireflux reimplantation did not seem to have any notable impact on renal function during the follow-up period.
Subject(s)
Laparoscopy , Robotic Surgical Procedures , Robotics , Ureter , Ureteral Obstruction , Vesico-Ureteral Reflux , Humans , Replantation , Retrospective Studies , Treatment Outcome , Ureter/surgery , Ureteral Obstruction/complications , Ureteral Obstruction/surgery , Vesico-Ureteral Reflux/surgeryABSTRACT
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Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Laparoscopy , Carcinoma, Renal Cell/surgery , Humans , Kidney Neoplasms/surgery , Nephrectomy , Treatment OutcomeABSTRACT
Oxygen therapies have been shown to be cytoprotective in a dose-dependent fashion. Previously, we have characterized the protective effects of moderate hyperoxia on cell viability of ischemic human cardiomyocytes and their mitochondrial membrane potential by transient addition of oxygenated perfluorocarbons to the cell medium. Now, we report that the activity and expression of cytochrome c oxidase (COX) after prolonged ischemia depend on the amount of oxygen delivered during reoxygenation. Transient hyperoxia during reoxygenation results in a decrease of COX activity by 62 +/- 15% and COX expression by 67 +/- 5%, when hyperoxic tensions of approximately = 300 mm Hg are reached in the cell medium. This decrease in COX expression is prevented by the inhibition of inducible nitric-oxide synthase (iNOS). Immunoblot analysis of ischemic human cardiomyocytes revealed that hyperoxic reoxygenation causes a 2-fold increase of iNOS, leading to a rise in nitric oxide production by 140 +/- 45%. Hyperoxic reoxygenation is further responsible for a 2-fold activation of hydrogen peroxide production and an increase in cytosolic superoxide dismutase expression by 35 +/- 10%. NADPH availability has no effect on the hyperoxia-induced decrease of superoxide. Overall, these results indicate that transient hyperoxic reoxygenation in optimal concentrations increases the level of nitric oxide by activation of iNOS and superoxide dismutase, thereby inducing respiration arrest in mitochondria of ischemic cardiomyocytes.
Subject(s)
Electron Transport Complex IV/chemistry , Gene Expression Regulation, Enzymologic , Hyperoxia/metabolism , Nitric Oxide/metabolism , Superoxide Dismutase/metabolism , Cell Survival , Cytosol/enzymology , Humans , Ischemia , Membrane Potential, Mitochondrial , Models, Biological , Myocytes, Cardiac/enzymology , NADP/metabolism , Nitric Oxide Synthase Type II/metabolism , Oxygen/chemistryABSTRACT
Both designing a clinical study and drawing conclusions from studies about the effect of treatments require justification of the sample size via judicious choice of the endpoint and power. Such an a priori power calculation limits the chances of mistakenly claiming a lack of clinical significance if no statistically significant difference between two treatments can be detected. Calculating the sample size for a new trial furthermore requires assessment of existing evidence to determine if its results will contribute to an updated meta-analysis. To rate the power of a meta-analysis, determination of the optimal information size is suggested, following the same principles as for calculating the power of a single trial. Even though these sample size considerations might seem like an additional hurdle, they are necessary to conduct clinical studies and meta-analysis that provide the optimal benefit for both clinicians and patients. PATIENT SUMMARY: Before conducting a clinical trial, researchers should determine how many patients need to be included to detect a difference between treatments. Even though a study might find a statistical difference between treatments, this does not necessarily mean that the difference is relevant for clinical use. These analyses before starting a study are important for producing worthwhile usable evidence for clinicians and patients.
Subject(s)
Sample Size , Urology , Clinical Trials as Topic , Humans , Meta-Analysis as TopicABSTRACT
This case report highlights the importance of a wide differential diagnosis in transgender patients. A 77-year-old transgender (female-to-male) with recurrent urinary tract infections (UTI) and obstructive voiding difficulties presented with a perineal cyst. Further examinations, including computed tomography (CT) and puncture, revealed that the patient had a symptomatic Bartholin gland cyst, a phenomenon that normally only affects women. In his gender confirmation surgery (GCS) 30 years before, the patient's female labia minora and Bartholin glands were used to lengthen the urethra for the phalloplasty. This explains the unusual location and the prolonged time to the correct diagnose. We decided to perform an incision of the fluid collection from perineal. A follow-up sonography after one month revealed a remaining cyst size of 6 mL, which was assumed to be residual fluid or newly produced liquid; however, the patient has not had any UTIs since the incision of the cyst. Our case seems to be the first description of a symptomatic Bartholin gland cyst in a trans man. This stresses the importance of an expanded understanding of sex/gender concepts, and underlines one of the many possible diagnostic pitfalls when treating trans people.
ABSTRACT
BACKGROUND: The necessity of antibiotic prophylaxis for postoperative urinary tract infections (UTIs) after transurethral resection of bladder tumours is controversial. This potentially leads to the overuse of antibiotic prophylaxis and rising antimicrobial resistance rates. The objective of this systematic review and meta-analysis is to compare the impact of different antimicrobial prophylaxis schemes versus placebo on the prevention of postoperative UTI and asymptomatic bacteriuria. METHODS: We designed and registered a study protocol for a systematic review and meta-analysis of randomized controlled trials and non-randomized (e.g. cohort, case-control) studies examining any form of antibiotic prophylaxis in patients with transurethral resection of bladder tumours. Literature searches will be conducted in several electronic databases (from inception onwards), including MEDLINE (Ovid), EMBASE (Ovid), and the Cochrane Central Register of Controlled Trials (CENTRAL). Grey literature will be identified through searching conference abstracts. The primary outcome will be postoperative urinary tract infections. The secondary outcome will be asymptomatic bacteriuria. Two reviewers will independently screen all citations, full-text articles, and abstract data. Potential conflicts will be resolved through discussion. The study methodological quality (or bias) will be appraised using appropriate tools (e.g. Risk of Bias 2.0 tool and Newcastle-Ottawa Scale). If feasible, we will conduct random-effects meta-analysis of outcome data. Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g. study design, publication year, the setting of the study, and antibiotics regimen). We will also search, identify, and discuss potential risk factors for urinary tract infections following transurethral resection of bladder tumours. This may serve as basis for a scoping review. DISCUSSION: In times of rising antimicrobial resistance rates, sound evidence on the necessity of antibiotic prophylaxis is essential for implementation into guideline recommendations and for decision-making in clinical practice. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42019131733.
Subject(s)
Urinary Bladder Neoplasms , Urinary Tract Infections , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Humans , Meta-Analysis as Topic , Postoperative Complications/drug therapy , Systematic Reviews as Topic , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/surgery , Urinary Tract Infections/drug therapy , Urinary Tract Infections/prevention & controlABSTRACT
BACKGROUND: Urinary Calprotectin, a mediator of the innate immune system, has been identified as a biomarker in bladder cancer. Our aim was to investigate the association between sterile leukocyturia and urinary Calprotectin in low-grade and high-grade bladder cancer. MATERIALS AND METHODS: We performed a prospective cross-sectional study including 52 patients with bladder cancer and 40 healthy controls. Definition of sterile leukocyturia was > 5.0 leukocytes per visual field in absence of bacteriuria. RESULTS: The rate of sterile leukocyturia in low-grade (60.0%) and high-grade (62.0%) bladder cancer was comparable (p = 0.87). However, the median absolute urinary leukocyte count in patients with sterile leukocyturia was significantly higher in high-grade than in low-grade bladder cancer (p < 0.01). Spearman correlation revealed a significant correlation between urinary Calprotectin and leucocyte concentration (R = 0.4, p < 0.001). Median urinary Calprotectin concentration was 4.5 times higher in bladder cancer patients with than in patients without sterile leukocyturia (p = 0.03). Subgroup analysis revealed a significant difference in urinary Calprotectin regarding the presence of sterile leukocyturia in high-grade patients (596.8 [91.8-1655.5] vs. 90.4 [28.0-202.3] ng ml-1, p = 0.02). Multivariate analysis identified the leukocyte concentration to be the only significant impact factor for urinary Calprotectin (OR 3.2, 95% CI 2.5-3.8, p = 0.001). Immunohistochemistry showed Calprotectin positive neutrophils and tumour cells in high-grade bladder cancer with sterile leukocyturia. CONCLUSIONS: Urinary Calprotectin cannot be regarded as a specific tumour marker for bladder cancer, but rather as a surrogate parameter for tumour inflammation.
Subject(s)
Biomarkers, Tumor/urine , Leukocyte L1 Antigen Complex/urine , Leukocytes/metabolism , Urinary Bladder Neoplasms/urine , Adult , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Humans , Leukocytes/pathology , Male , Middle Aged , Prospective Studies , Urinary Bladder Neoplasms/pathologyABSTRACT
BACKGROUND: Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is recommended to reduce postoperative urinary tract infections. So far, no international recommendations for AP have been established for GL. In a survey-based study in Switzerland, Germany and Austria, urologists reported routinely extending AP primarily for 3 days after both interventions. We therefore aim to determine whether single-dose AP with cotrimoxazole is non-inferior to 3-day AP with cotrimoxazole in patients undergoing TURP or GL of the prostate. METHODS/DESIGN: We will conduct an investigator-initiated, multicentre, randomised controlled trial. We plan to assess the non-inferiority of single-dose AP compared to 3-day AP. The primary outcome is the occurrence of clinically diagnosed symptomatic urinary tract infections which are treated with antimicrobial agents within 30 days after randomisation. The vast majority of collected outcomes will be assessed from routinely collected data. The sample size was estimated to be able to show the non-inferiority of single-dose AP compared to 3-day AP with at least 80% power (1 - ß = 0.8) at a significance level of α = 5%, applying a 1:1 randomisation scheme. The non-inferiority margin was determined in order to preserve 70% of the effect of usual care on the primary outcome. For an assumed event rate of 9% in both treatment arms, this resulted in a non-inferiority margin of 4.4% (i.e. 13.4% to 9%). To prove non-inferiority, a total of 1574 patients should be recruited, in order to have 1416 evaluable patients. The study is supported by the Swiss National Science Foundation. DISCUSSION: For AP in TURP and GL, there is a large gap between usual clinical practice and evidence-based guidelines. If single-dose AP proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine-potentially reducing the risk of emerging resistance and complications related to AP. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03633643 . Registered 16 August 2018.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Anti-Infective Agents, Urinary/administration & dosage , Antibiotic Prophylaxis/methods , Laser Therapy/methods , Prostatic Hyperplasia/surgery , Prostatic Neoplasms/surgery , Transurethral Resection of Prostate/methods , Trimethoprim, Sulfamethoxazole Drug Combination/administration & dosage , Urinary Tract Infections/prevention & control , Anti-Bacterial Agents/adverse effects , Anti-Infective Agents, Urinary/adverse effects , Antibiotic Prophylaxis/adverse effects , Drug Administration Schedule , Equivalence Trials as Topic , Humans , Laser Therapy/adverse effects , Male , Multicenter Studies as Topic , Prostatic Hyperplasia/diagnosis , Prostatic Neoplasms/diagnosis , Switzerland , Time Factors , Transurethral Resection of Prostate/adverse effects , Treatment Outcome , Trimethoprim, Sulfamethoxazole Drug Combination/adverse effects , Urinary Tract Infections/diagnosis , Urinary Tract Infections/microbiologyABSTRACT
OBJECTIVE: To evaluate the current antimicrobial prophylaxis practices for low-risk patients undergoing transurethral resection of the prostate (TURP) or photoselective vaporisation of the prostate (PVP) in comparison with the antimicrobial prophylaxis recommendations of the European Association of Urology (EAU), which have been shown to effectively reduce infectious complications and antimicrobial resistance rates. METHODS: In May 2017, we sent an anonymous online -survey to board-certified urologists in Germany, Austria and Switzerland, by use of the database directory of the respective urology associations. Besides demographical questions, urologists were asked about their sources of information on antimicrobial prophylaxis prescription and their prescribing patterns before, during and after surgery in patients without an indwelling catheter or significant bacteriuria undergoing TURP or PVP. RESULTS: Overall, 374 of 5825 urologists responded, of whom 76% (286/374) performed TURP and 16% (60/374) PVP. For TURP and PVP, respectively: (i) 42% (119/286) and 33% (20/60) reported routine use of preoperative antimicrobial prophylaxis, which does not conform to guideline recommendations; (ii) 43% (124/286) and 52% (31/60) reported prescribing non-recommended perioperative antimicrobial prophylaxis regimens; and (iii) 60% (172/286) and 65% (39/60) routinely extended antimicrobial prophylaxis after surgery for up to one week. In summary, of the urologists who responded to the questionnaire, 74% (211/286) reported nonadherence to guidelines on antimicrobial prophylaxis for TURP. CONCLUSION: A low adherence to guidelines for low-risk patients undergoing TURP or PVP was reported. Given these preliminary data, there is an urgent need to monitor adherence to antimicrobial prophylaxis guidelines in urology to reduce antimicrobial resistance rates.