Lack of evidence for effects of lockdowns on stillbirth rates during the SARS-CoV-2 pandemic in Bavaria: analysis of the Bavarian perinatal survey from 2010 to 2020.

BACKGROUND: Internationally, potential effects of national SARS-CoV-2-related lockdowns on stillbirth rates have been reported, but data for Germany, including risk factors for fetal pregnancy outcome, are lacking. The aim of this study is to compare the stillbirth rates during the two first lockdown periods in 2020 with previous years from 2010 to 2019 in a large Bavarian cohort. METHODS: This study is a secondary analysis of the Bavarian perinatal data from 2010 to 2020, including 349,245 births. Univariate and multivariable regression analyses were performed to investigate the effect of two Bavarian lockdowns on the stillbirth rate in 2020 compared to the corresponding periods from 2010 to 2019. RESULTS: During the first lockdown, the stillbirth rate was significantly higher compared to the reference period (4.04 vs. 3.03 stillbirths per 1000 births; P = 0.03). After adjustment for seasonal and long-term trends, this effect can no longer be observed (P = 0.2). During the second lockdown, the stillbirth rate did not differ in univariate (3.46 vs. 2.93 stillbirths per 1000 births; P = 0.22) as well as in multivariable analyses (P = 0.68), compared to the years 2010 to 2019. CONCLUSION: After adjustment for known long-term effects, in this study we did not find evidence that the two Bavarian lockdowns had an effect on the rate of stillbirths.

Association Between Adherence to Quality Indicators and 7-Day In-Hospital Mortality After Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Quality indicators (QI) are an accepted tool to measure performance of hospitals in routine care. We investigated the association between quality of acute stroke care defined by overall adherence to evidence-based QI and early outcome in German acute care hospitals. METHODS: Patients with ischemic stroke admitted to one of the hospitals cooperating within the ADSR (German Stroke Register Study Group) were analyzed. The ADSR is a voluntary network of 9 regional stroke registers monitoring quality of acute stroke care across 736 hospitals in Germany. Quality of stroke care was defined by adherence to 11 evidence-based indicators of early processes of stroke care. The correlation between overall adherence to QI with outcome was investigated by assessing the association between 7-day in-hospital mortality with the proportion of QI fulfilled from the total number of QI the individual patient was eligible for. Generalized linear mixed model analysis was performed adjusted for the variables age, sex, National Institutes of Health Stroke Scale and living will and as random effect for the variable hospital. RESULTS: Between 2015 and 2016, 388 012 patients with ischemic stroke were reported (median age 76 years, 52.4% male). Adherence to distinct QI ranged between 41.0% (thrombolysis in eligible patients) and 95.2% (early physiotherapy). Seven-day in-hospital mortality was 3.4%. The overall proportion of QI fulfilled was median 90% (interquartile range, 75%-100%). In multivariable analysis, a linear association between overall adherence to QI and 7-day in-hospital-mortality was observed (odds ratio adherence <50% versus 100%, 12.7 [95% CI, 11.8-13.7]; P<0.001). CONCLUSIONS: Higher quality of care measured by adherence to a set of evidence-based process QI for the early phase of stroke treatment was associated with lower in-hospital mortality.

Stroke unit care in germany: the german stroke registers study group (ADSR).

BACKGROUND: Factors influencing access to stroke unit (SU) care and data on quality of SU care in Germany are scarce. We investigated characteristics of patients directly admitted to a SU as well as patient-related and structural factors influencing adherence to predefined indicators of quality of acute stroke care across hospitals providing SU care. METHODS: Data were derived from the German Stroke Registers Study Group (ADSR), a voluntary network of 9 regional registers for monitoring quality of acute stroke care in Germany. Multivariable logistic regression analyses were performed to investigate characteristics influencing direct admission to SU. Generalized Linear Mixed Models (GLMM) were used to estimate the influence of structural hospital characteristics (percentage of patients admitted to SU, year of SU-certification, and number of stroke and TIA patients treated per year) on adherence to predefined quality indicators. RESULTS: In 2012 180,887 patients were treated in 255 hospitals providing certified SU care participating within the ADSR were included in the analysis; of those 82.4% were directly admitted to a SU. Ischemic stroke patients without disturbances of consciousness (p < .0001), an interval onset to admission time ≤3 h (p < .0001), and weekend admission (p < .0001) were more likely to be directly admitted to a SU. A higher proportion of quality indicators within predefined target ranges were achieved in hospitals with a higher proportion of SU admission (p = 0.0002). Quality of stroke care could be maintained even if certification was several years ago. CONCLUSIONS: Differences in demographical and clinical characteristics regarding the probability of SU admission were observed. The influence of structural characteristics on adherence to evidence-based quality indicators was low.

Variations in acute hospital stroke care and factors influencing adherence to quality indicators in 6 European audits.

BACKGROUND AND PURPOSE: We compared compliance with standards of acute stroke care between 6 European audits and identified factors associated with delivery of appropriate care. METHODS: Data were derived from stroke audits in Germany, Poland, Scotland, Catalonia, Sweden, and England/Wales/Northern-Ireland participating within the European Implementation Score (EIS) collaboration. Associations between demographic and clinical characteristics with adherence to predefined quality indicators were investigated by hierarchical logistic regression analyses. RESULTS: In 2007/2008 data from 329 122 patients with stroke were documented. Substantial variations in adherence to quality indicators were found; older age was associated with a lower probability of receiving thrombolytic therapy, anticoagulant therapy, or stroke unit treatment and a higher probability of being tested for dysphagia. Women were less likely to receive anticoagulant or antiplatelet therapy or stroke unit treatment. No major weekend effect was found. CONCLUSIONS: Detected variations in performance of acute stroke services were found. Differences in adherence to quality indicators might indicate population subgroups with specific needs for improving care delivery.

Variations in quality indicators of acute stroke care in 6 European countries: the European Implementation Score (EIS) Collaboration.

BACKGROUND AND PURPOSE: Quality indicators serve as standards of care by which performance of individual hospitals is measured. Although several audits for monitoring quality of stroke care have been established in Europe, there is currently no consensus on quality indicators for acute stroke care or for methodology for collecting information on these measures. METHODS: An up-to-date inventory on European stroke audits in place in 2006 was performed in the course of a project funded by the European Union (European Implementation Score Collaboration [EIS]). Two regional (Flanders, Belgium; Catalonia, Spain) and 4 national (Germany, Scotland, Sweden, England/Wales/Northern Ireland) stroke audits took part. Between November 2009 and July 2010, 2 standardized surveys and a series of interviews were performed to determine characteristics, methods, and content of these quality initiatives. For quality purposes, all summarized information was validated by representatives of the respective audits. RESULTS: Overall, 123 quality indicators (91 process, 24 outcome, and 8 structural indicators) were identified. Anticoagulants in patients with atrial fibrillation and brain imaging were the only quality indicators used in all, whereas another 13 indicators were used in at least 2 of the quality initiatives. Substantial variations were found across the audits in terms of the development process of quality indicators, inclusion criteria, participation, population coverage, data documentation, follow-ups, benchmarking, and feedback of results to participants. CONCLUSIONS: There is a huge variety in measuring performance of acute stroke care in Europe, hampering valid comparisons of acute stroke care. Common standards for defining quality indicators and collecting information required for these measures should be defined in Europe.

Stroke care during the COVID-19 pandemic: Case numbers, treatments, and mortality in two large German stroke registries.

Background and purpose: At the beginning of the SARS-CoV-2 pandemic, an alarming decline in hospitalizations for stroke was reported in several countries, including Germany. We assessed hospitalization numbers and indicators of the quality of stroke care in 2020 during the pandemic containment measures. Materials and methods: The analysis was based on data of two large stroke quality assurance registries in the north and the south of Germany (Qualitätssicherung Schlaganfall Nordwestdeutschland and Bayerische Arbeitsgemeinschaft für Qualitätssicherung in der stationären Versorgung). We included 395 hospitals with 467,931 documented cases in 2018-2020. The time interval between admission and thrombolysis, frequency of systemic thrombolysis and intra-arterial therapy (IAT), National Institutes of Health Stroke Scale (NIHSS) score on admission and in-hospital mortality were assessed. Changes in the second (Q2) and fourth (Q4) quarters of 2020 were compared to corresponding quarters in 2019 by chi-squared tests. Results: Hospitalization numbers decreased in the two stroke registries by 8% and 10% in Q2 of 2020 and by 5% and 15% in Q4 of 2020 compared to the same quarters in 2019, respectively. The decline was particularly seen in women and patients with transient ischemic attacks. In cases with cerebral infarction, no increase in NIHSS scores on admission was observed, and the proportion of patients with a time interval between admission and thrombolysis of ≤60 min was unchanged. No clear pattern was found in the frequency of systemic thrombolysis and IAT. In one of the registries, in-hospital mortality of patients with cerebral infarction increased in Q2 of 2020 compared to Q2 of 2019. Conclusion: Case numbers slightly decreased under pandemic conditions, while our quarterly analysis indicated that the quality of stroke care was largely unchanged throughout the year 2020.

Limited Effects of SARS-CoV-2 Pandemic-related Lockdowns and Reduced Population Mobility on Preterm Birth Rates: A Secondary Analysis of Bavarian Obstetric Quality Parameters from 2010 to 2020.

Introduction International studies on preterm birth rates during COVID-19 lockdowns report different results. This study examines preterm birth rates during lockdown periods and the impact of the mobility changes of the population in Bavaria, Germany. Material and Methods This is a secondary analysis of centrally collected data on preterm births in Bavaria from 2010 to 2020. Preterm births (< 37 weeks) in singleton and twin pregnancies during two lockdowns were compared with corresponding periods in 2010 - 2019. Fisher's exact test was used to compare raw prevalence between groups. Potential effects of two fixed lockdown periods and of variable changes in population mobility on preterm birth rates in 2020 were examined using additive logistic regression models, adjusting for long-term and seasonal trends. Results Unadjusted preterm birth rates in 2020 were significantly lower for singleton pregnancies during the two lockdown periods (Lockdown 1: 5.71% vs. 6.41%; OR 0.88; p < 0.001; Lockdown 2: 5.71% vs. 6.60%; OR = 0.86; p < 0.001). However, these effects could not be confirmed after adjusting for long-term trends (Lockdown 1: adj. OR = 0.99; p = 0.73; Lockdown 2: adj. OR = 0.96; p = 0.24). For twin pregnancies, differences during lockdown were less marked (Lockdown 1: 52.99% vs. 56.26%; OR = 0.88; p = 0.15; Lockdown 2: 58.06% vs. 58.91%; OR = 0.97; p = 0.70). Reduced population mobility had no significant impact on preterm birth rates in singleton pregnancies (p = 0.14) but did have an impact on twin pregnancies (p = 0.02). Conclusions Reduced preterm birth rates during both lockdown periods in 2020 were observed for singleton and twin pregnancies. However, these effects are reduced when adjusting for long-term and seasonal trends. Reduced population mobility was associated with lower preterm birth rates in twin pregnancies.

Predictors of death and stroke after carotid angioplasty and stenting: a subgroup analysis of the Pro-CAS data.

BACKGROUND AND PURPOSE: Little is known about the significance of patient characteristics, clinical indications, and technical details on the risk of carotid angioplasty and stenting (CAS). The purpose of this study was to test these parameters as to their predictive value for the peri-interventional risk of CAS. METHODS: Pro-CAS is a prospective, multicenter registry of CAS. Logistic regression analysis of possible predictive factors was performed on 5341 interventions that had been entered by 25 clinical centers between July 1999 and June 2005. RESULTS: The combined in-hospital mortality and stroke rate was 3.6%. The following were found to be significant predictors of peri-interventional stroke and death: center experience (< or = 50 versus 51 to 150 versus > or = 151 interventions), age, prior symptoms, primary intervention as compared with intervention for restenosis, angioplasty without stent, predilatation, and heparin dosage > 5000 IU. No statistically significant result was found for year of intervention, patient volume, gender, interval between symptoms and CAS, ocular versus neurological symptoms, side of CAS, degree of stenosis of the target lesion, presence of contralateral high-degree stenosis or occlusion, method of gaining access to the carotids, stent type, and use of a protection system. CONCLUSIONS: Our findings underline the need for dedicated training and strict credentialing rules for CAS. In addition, they might help to identify subgroups of patients at differential risk for CAS and carotid endarterectomy and yield a basis for correcting risks due to differences in case mix in reports about CAS.

Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients.

PURPOSE: Transurethral resection of the prostate has for decades been the standard surgical therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia, the most common benign neoplasm in men. To generate a contemporary reference for evolving medical and minimally invasive therapies we analyzed complications and immediate outcomes of transurethral prostate resection in a statewide multicenter study. MATERIALS AND METHODS: We prospectively evaluated 10,654 patients undergoing transurethral prostate resection in the state of Bavaria, Germany from January 1, 2002 until December 31, 2003. Case records containing 54 items concerning preoperative status, operation details, complications and immediate outcome, were recorded for each patient. RESULTS: The mortality rate for transurethral prostate resection was 0.10%. The cumulative short-term morbidity rate was 11.1%. The most relevant complications were failure to void (5.8%), surgical revision (5.6%), significant urinary tract infection (3.6%), bleeding requiring transfusions (2.9%) and transurethral resection syndrome (1.4%). The resected tissue averaged 28.4 gm. Incidental carcinoma of the prostate was diagnosed by histological examination in 9.8% of patients. Urinary peak flow rate increased significantly to 21.6 +/- 9.4 ml per second (baseline 10.4 +/- 6.8 ml per second, 1 tail p <0.0001), while post-void residual decreased to 31.1 +/- 73.0 ml (baseline 180.3 +/- 296.9 ml, 1-tail p <0.0001). CONCLUSIONS: In a large scale evaluation comprising 44 mostly nonacademic urological departments in Bavaria, unique real-world data for transurethral prostate resection were prospectively generated. This most contemporary information should be of use to potential patients and facilitate subsumption of emerging surgical and nonsurgical benign prostatic hyperplasia treatment options.

Development and implementation of evidence-based indicators for measuring quality of acute stroke care: the Quality Indicator Board of the German Stroke Registers Study Group (ADSR).

BACKGROUND AND PURPOSE: There is no consensus about indicators for measuring quality of acute stroke care in Germany. Therefore, a standardized process was initiated recently to develop and implement evidence-based indicators for the measurement of quality of acute hospital stroke care. METHODS: Quality indicators were developed by a multidisciplinary board between November 2003 and December 2005. The process was initiated by the German Stroke Registers Study Group in cooperation with the German Stroke Society, the German Society of Neurology, the German Stroke Foundation, Regional Offices for Quality Assurance and other experts proven in the field. National and international recommendations were considered during the development process. The process was based on a systematic literature review, an independent external evaluation of the process and its results, and a prospective pilot study to evaluate the defined indicators in clinical practice. RESULTS: Overall a set of 24 indicators was developed to measure performance of acute care hospitals in the 3 health care dimensions structure, process and outcome as well as in 3 treatment phases prehospital, in-hospital/acute and postacute. Practicability of the derived indicators was tested in a prospective pilot study. During a 2-month period, 1006 patients in 13 hospitals were documented. Application of the new indicator set was found to be feasible by participating physicians and hospitals. Median time to document the required information for 1 patient was 5 minutes. Nationwide implementation of the new indicator set within regional registers in Germany started since April 2006. CONCLUSIONS: The development of indicators to measure hospital performance in stroke care is an important step toward improving stroke care on a national level. The chosen standardized evidence-based approach ensures maximal transparency, acceptance and sustainability of the developed indicators in Germany.

Predictors of in-hospital mortality and attributable risks of death after ischemic stroke: the German Stroke Registers Study Group.

BACKGROUND: There is a lack of information about factors associated with in-hospital death and the impact of neurological complications on early outcome for patients with stroke treated in community settings. We investigated predictors for in-hospital mortality and attributable risks of death after ischemic stroke in a pooled analysis of large German stroke registers. METHODS: Stroke patients admitted to hospitals cooperating within the German Stroke Registers Study Group (ADSR) between January 1, 2000, and December 31, 2000, were analyzed. The ADSR is a network of regional stroke registers, combining data from 104 academic and community hospitals throughout Germany. The impact of patients' demographic and clinical characteristics, their comorbid conditions, and the treating hospital expertise in stroke care on in-hospital mortality was analyzed using Cox regression analysis. Attributable risks of death for medical and neurological complications were calculated. RESULTS: A total of 13 440 ischemic stroke patients were included. Overall in-hospital mortality was 4.9%. In women, higher age (P<.001), severity of stroke defined by number of neurological deficits (P<.001), and atrial fibrillation (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.0-1.6) were independent predictors for in-hospital death. In men, diabetes (HR, 1.3; 95% CI, 1.0-1.8) and previous stroke (HR 1.4; 95% CI, 1.0-1.9) had a significant negative impact on early outcome in addition to the factors identified for women. The complication with the highest attributable risk proportion was increased intracranial pressure, accounting for 94% (95% CI, 93.9%-94.1%) of deaths among patients with this complication. Pneumonia was the complication with the highest attributable proportion of death in the entire stroke population, accounting for 31.2% (95% CI, 30.9%-31.5%) of all deaths. More than 50% of all in-hospital deaths were caused by serious medical or neurological complications (54.4%; 95% CI, 54.3%-54.5%). CONCLUSIONS: Substantial differences were found in the impact of comorbid conditions on early outcome for men and women. Programs aiming at an improvement in short-term outcome after stroke should focus especially on a reduction of pneumonia and an early treatment of increased intracranial pressure.

Temporal Changes in the Quality of Acute Stroke Care in Five National Audits across Europe.

Background. Data on potential variations in delivery of appropriate stroke care over time are scarce. We investigated temporal changes in the quality of acute hospital stroke care across five national audits in Europe over a period of six years. Methods. Data were derived from national stroke audits in Germany, Poland, Scotland, Sweden, and England/Wales/Northern Ireland participating within the European Implementation Score (EIS) collaboration. Temporal changes in predefined quality indicators with comparable information between the audits were investigated. Multivariable logistic regression analyses were performed to estimate adherence to quality indicators over time. Results. Between 2004 and 2009, individual data from 542,112 patients treated in 538 centers participating continuously over the study period were included. In most audits, the proportions of patients who were treated on a SU, were screened for dysphagia, and received thrombolytic treatment increased over time and ranged from 2-fold to almost 4-fold increase in patients receiving thrombolytic therapy in 2009 compared to 2004. Conclusions. A general trend towards a better quality of stroke care defined by standardized quality indicators was observed over time. The association between introducing a specific measure and higher adherence over time might indicate that monitoring of stroke care performance contributes to improving quality of care.

Frequency of thrombolytic therapy in patients with acute ischemic stroke and the risk of in-hospital mortality: the German Stroke Registers Study Group.

BACKGROUND AND PURPOSE: There is little information about early outcome after intravenous application of tissue-type plasminogen activator (tPA) for stroke patients treated in community-based settings. We investigated the association between tPA therapy and in-hospital mortality in a pooled analysis of German stroke registers. METHODS: Ischemic stroke patients admitted to hospitals cooperating within the German Stroke Registers Study Group (ADSR) between January 1, 2000, and December 31, 2000, were analyzed. The ADSR is a network of regional stroke registers, combining data from 104 academic and community hospitals throughout Germany. Patients treated with tPA were matched to patients not receiving tPA on the basis of propensity scores and were analyzed with conditional logistic regression. Analyses were stratified for hospital experience with the administration of tPA. RESULTS: A total of 13,440 ischemic stroke patients were included. Of these, 384 patients (3%) were treated with tPA. In-hospital mortality was significantly higher for patients treated with tPA compared with patients not receiving tPA (11.7% versus 4.5%, respectively; P<0.0001). After matching for propensity score, overall risk of inpatient death was still increased for patients treated with tPA (odds ratio [OR], 1.7; 95% CI, 1.0 to 2.8). Patients receiving tPA in hospitals that administered 5 thrombolytic treatments per year (OR, 1.3; 95% CI, 0.8 to 2.4). CONCLUSIONS: In-hospital mortality of ischemic stroke patients after tPA use varied between hospitals with different experience in tPA treatment in routine clinical practice. Our study suggested that thrombolytic therapy in hospitals with limited experience in its application increase the risk of in-hospital mortality.

Pro-CAS: a prospective registry of carotid angioplasty and stenting.

BACKGROUND AND PURPOSE: The German Societies of Angiology and Radiology have instituted a prospective registry of carotid angioplasty and stenting (CAS) to limit uncontrolled use of CAS and to collect data about technique and results of CAS outside clinical trials. METHODS: A total of 38 centers register their patients prospectively before CAS is performed. At discharge, technical details, periprocedural medication, and the clinical course are reported on a standardized form. RESULTS: During the first 48 months, 3853 planned interventions were recorded, and CAS was actually attempted on 3267 patients of whom 1827 (56%) were symptomatic and 1433 (44%) were asymptomatic. In 3127 (98%) cases, stents were used, of which 2784 (89%) were of the self-expanding type. Other technical aspects such as the use of guiding catheters and protection devices varied widely among the centers. Periprocedural medication rather uniformly included aspirin and clopidogrel before and after CAS and high-dose heparin and atropin during CAS. CAS was successful in 3207 (98%) cases. There was a 0.6% (n=18) mortality rate, a 1.2% (n=38) major stroke rate, and a 1.3% (n=41) minor stroke rate. The combined stroke and death rate was 2.8% (n=90). CONCLUSIONS: These prospective multicenter data are likely to give a realistic picture of the possibilities and limitations of CAS in the general community. They suggest that CAS may be performed with similar results in the general community as they have been reported by highly specialized centers and in clinical studies.

Predictors of in-hospital mortality in patients with acute ischemic stroke treated with thrombolytic therapy.

CONTEXT: Data are limited regarding the risks and benefits of thrombolytic therapy for acute ischemic stroke outside of clinical trials. OBJECTIVE: To investigate predictors of in-hospital mortality in patients with ischemic stroke treated with intravenous tissue plasminogen activator (tPA) within a pooled analysis of large German stroke registers. DESIGN AND SETTING: Prospective, observational cohort study conducted at 225 community and academic hospitals throughout Germany cooperating within the German Stroke Registers Study Group. PATIENTS: A total of 1658 patients with acute ischemic stroke who were admitted to study hospitals between 2000 and 2002 and were treated with tPA. MAIN OUTCOME MEASURE: In-hospital mortality. RESULTS: One hundred sixty-six patients (10%) who received tPA died during hospitalization, with 67.5% of these deaths occurring within 7 days. Factors predicting in-hospital death after tPA use were older age (for each 10-year increment in age, adjusted odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.9) and altered level of consciousness (adjusted OR, 3.4; 95% CI, 2.4-4.7). The overall rate of symptomatic intracranial hemorrhage was 7.1% and increased with age. One or more serious complications was observed in 27.2% of all patients and in 83.9% of patients who died after tPA treatment. An inverse relation between the number of patients treated with tPA in the respective hospital and the risk of in-hospital death was observed (adjusted OR, 0.97; 95% CI, 0.96-0.99 for each additional patient treated with tPA per year). CONCLUSION: In patients with ischemic stroke who are treated with tPA, disturbances of consciousness and increasing age are associated with increased in-hospital mortality.

Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study.

PURPOSE: We prospectively analyzed the complications and immediate postoperative outcome of open prostatectomy for benign prostatic hyperplasia to provide reference data for emerging techniques, such as holmium laser enucleation of the prostate and laparoscopic prostatectomy. MATERIALS AND METHODS: A total of 902 patients with a mean +/- 1 SD age of 71.3 +/- 6.8 years were evaluated while undergoing open prostatectomy in Bavaria, Germany from January 1, 2002 to December 31, 2003. We prospectively analyzed 54 parameters concerning preoperative status, surgical details, complications and immediate outcome. RESULTS: Mean operative time was 80.8 +/- 34.2 minutes. Mean prostate size was 96.3 +/- 37.4 ml. Average enucleated tissue was 84.8 +/- 44.0 gm. Incidental carcinoma of the prostate was found in 28 of 902 patients (3.1%) and the mortality rate was 0.2%. The overall complication rate was 17.3%. The most relevant complications were bleeding requiring transfusion in 68 cases (7.5%), urinary tract infection in 46 (5.1%) and surgical revision due to severe bleeding in 33 (3.7%). Patients had an average International Prostate Symptom Score of 20.7 +/- 7.6 preoperatively. Mean urinary peak flow rate increased significantly to 23.1 +/- 10.5 ml per second from a baseline of 10.6 +/- 6.4 ml per second (p <0.0001). Post-void residual volume decreased to 17.5 +/- 34.8 ml from a baseline of 145.1 +/- 152.8 ml (p <0.0001). CONCLUSIONS: Open prostatectomy showed a satisfactory early postoperative outcome with a complication rate that was within the expected range compared to that in the recent literature. It represents an important option in the treatment of patients with significant benign enlargement of the prostate for surgeons with no access to modern techniques, such as holmium laser enucleation of the prostate or laparoscopy.