Reduced incidence of blindness in relation to diabetes mellitus in southern Germany?

AIMS: We estimated the incidence of blindness in the diabetic and non-diabetic population in 2008 and compared it with results from 1990-1998 in a neighbouring region. METHODS: All newly registered blindness allowance recipients in 2008 were drawn up in a German region (population 4.5 million). We estimated sex-specific, age-specific and standardized incidence rates of blindness in the diabetic and the non-diabetic population and relative and attributable risks as a result of diabetes. A comparison to the data from 1990-1998 was performed using log-linear Poisson regression. RESULTS: Four-hundred and sixty-eight cases were drawn up (63% female). One-hundred and twenty-two (26.1%) had diabetes. Blindness incidence rates (per 100, 000 person-years) standardized to the 2008 German population were: men 9.1 (95% confidence interval 7.8-10.5), women 9.9 (8.8-11.1); diabetic population: men 21.8 (11.6-31.9), women 19.7 (9.2-30.1); non-diabetic population: men 8.0 (6.6-9.5), women 9.1 (7.9-10.3). Relative risk of blindness, diabetic vs. non-diabetic population: men 2.7 (1.6-4.5), women 2.2 (1.3-3.8). Attributable risk among exposed: 63% in men, 54% in women. Population attributable risk: 12% in men, 8% in women. Incidences of blindness were significantly lower than in all years of the period 1990-1998 in both the diabetic and the non-diabetic population. CONCLUSIONS: We found the incidence of blindness to be approximately 2.5-fold higher in the diabetic compared with the non-diabetic population. Fifty-eight per cent of the risk to become blind in diabetic individuals and 9% of the risk to become blind in the entire population were attributable to diabetes. The decrease of the blindness incidence observed during the 1990s may have continued.

Incidence of lower limb amputations and diabetes.

OBJECTIVE: We collected data on the incidence rates of amputations and their relative risk in diabetic subjects compared with the nondiabetic population. RESEARCH DESIGN AND METHODS: From all three hospitals in a city of approximately 160,000 inhabitants, we obtained complete lists of nontraumatic lower limb amputations. From each patient record, diabetic status was determined. We estimated age-specific and standardized incidence rates of amputations in the diabetic and nondiabetic populations and in the entire population, as well as the relative and attributable risks due to diabetes. RESULTS: Nontraumatic lower limb amputations were performed on 106 residents of Leverkusen (Germany) in 1990 and 1991. Of them, 82 (77.4%) had diabetes. Mean age was 72.0 years. In the case of multiple amputations, only the highest level was counted for the analysis. The following results were standardized to the German population. Incidence rates (100,000(-1) year-1) were determined to be as follows: for all amputations per total population, 33.8; for amputations in diabetic individuals per diabetic population, 209.2; for amputations in nondiabetic individuals per nondiabetic population, 9.4. Relative risk was 22.2; attributable risk among exposed, 0.96; population attributable risk, 0.72. When the study is repeated to monitor the St. Vincent targets (50% reduction), a reduction in the amputation rate in the diabetic population by 46% will be detected with 90% power. CONCLUSIONS: We found incidence rates similar to those in the non-Indian population of the U.S. Great relative and population-attributable risks indicate that improving foot care in diabetic individuals appears to be the main target for the reduction of amputations in the general population.

Incidence of blindness in relation to diabetes. A population-based study.

OBJECTIVE: A reduction of diabetes-related blindness was declared a primary objective for Europe (St. Vincent Declaration). We collected data about incidence rates of blindness in the diabetic population compared with the nondiabetic population. Up to now, such data are scarce-even worldwide. RESEARCH DESIGN AND METHODS: A complete list of newly registered blindness allowance recipients was drawn up in the district of Württemberg-Hohenzollern, Germany, between 1990 and 1993. From these data, we estimated age-specific and standardized incidence rates of blindness in the entire, the diabetic, and the nondiabetic population, as well as relative and attributable risks due to diabetes. RESULTS: There were 2,714 people meeting the inclusion criteria; 1,823 (67.2%) were female and 781 (28.8%) had diabetes. In 318 subjects, diabetes was likely to be the only cause of blindness; in 192 subjects, it was one of several contributory causes. Age of women was 73.9 +/- 19.4 years (mean +/- SD) and of men 63.3 +/- 25.5 years. Results standardized to the (West) German population are as follows: incidence rates (per 100,000 person-years): total population: 13.5; diabetic population: 60.6; nondiabetic population: 11.6; relative risk: 5.2; attributable risk among exposed: 0.81; and population attributable risk: 0.14. The relative risks decreased considerably with increasing age. When the study is repeated to monitor the St. Vincent targets, a reduction in the incidence rate of blindness in the diabetic population by 17% will be detected with 95% power. CONCLUSIONS: Great relative and attributable risks, especially in younger age-groups, indicate the need for increased attention to preventive measures for microvascular complications.

Unchanged incidence of lower-limb amputations in a German City, 1990-1998.

OBJECTIVE: A reduction of diabetes-related amputations by at least one-half within 5 years was declared a primary objective for Europe (St. Vincent Declaration, 1989). We collected data about incidence rates of amputations in one German city (Leverkusen, with a population of approximately 160,000 inhabitants) between 1990 and 1998 to ascertain a potential change in rates of incidence. RESEARCH DESIGN AND METHODS: From all three hospitals in Leverkusen, we obtained complete lists of lower-limb amputations. From each patient record, diabetic status was determined. Only the first observed amputation was counted for the analysis. We estimated incidence rates of amputations in the entire population, the diabetic population, and the nondiabetic population. To test for time trend, we fitted Poisson regression models, adjusting for age and sex. RESULTS: During, the defined period (the years 1990, 1991, and 1994-1998), 339 patients (all residents of Leverkusen) without previous amputations had nontraumatic lower-limb amputations. Of all subjects. 46% were female. Moreover, 76% of the subjects were known to have diabetes. Mean age was 71.3 years. Incidence rates in the diabetic population (standardized to the estimated German diabetic population, per 100,000 person-years) were as follows: 1990, 549; 1991, 356; 1994, 544; 1995, 386; 1996, 426; 1997, 433; and 1998, 463. The Poisson models showed no significant change of incident amputations over time in the diabetic population or in the nondiabetic population. CONCLUSIONS: Beyond random variation, no change of incidence rates could be observed over the past 9 years. More specific interventions are needed to achieve a substantial reduction of diabetes-related amputations.

Diabetes as a predictor of mortality in a cohort of blind subjects.

BACKGROUND: There is only a little information about survival in newly registered blind subjects. METHODS: A closed cohort of blind subjects (n = 2680, 1803 of them women), newly registered between 1990 and 1993 in the district of Württemberg-Hohenzollern, Germany, was observed for up to 48 months. Mortality was compared to that of the general population. Predictors of mortality within that cohort were identified by Cox proportional hazards regression analysis. RESULTS: Before 1 February 1994, 582 of the subjects had died. Diabetes had been diagnosed in 772 of the subjects, 226 of them died. The overall incidence rate of death was 12179 per 100,000 per year. The probability of survival after 47 months was 0.64 (95% confidence interval (CI): 0.59-0.70) in the non-diabetic, and 0.46 (95% CI: 0.37-0.55) in the diabetic subjects. Predictors of mortality in the regression model were age (risk ratio [RR] per year of age 1.047), sex (RR for men 1.247) and diabetes (RR when blindness was unrelated to diabetes: 1,448, RR when diabetes was the only cause of blindness: 2,253). Compared with the entire population, mortality was considerably increased in the blind cohort (comparative mortality figure [CMF] 4.79), particularly in individuals with diabetes (CMF = 6.55). The relative risks decreased with increasing age. CONCLUSIONS: Overall mortality in this cohort was high, even higher than in previous studies on the mortality of the blind. Diabetes increased the risk of death. In addition, the cause of blindness in diabetic individuals was a major predictor of mortality.

Incidence of lower-limb amputations in the diabetic compared to the non-diabetic population. findings from nationwide insurance data, Germany, 2005-2007.

INTRODUCTION: One major objective is to reduce the risk of lower limb amputation in diabetes mellitus. Nationwide data to incidences of amputations in the diabetic and non-diabetic populations in Germany as well as relative and attributable risks due to diabetes are lacking so far. MATERIAL AND METHODS: Using data of a nationwide statutory health insurance (1.6 million members), we assessed all first non-traumatic lower-limb amputations between 2005 and 2007. We estimated sex-age-specific and standardized incidences of amputations in the diabetic and non-diabetic populations, and relative and attributable risks due to diabetes. RESULTS: Of all subjects with a first amputation in the study period 2005-2007 (n=994), 66% had diabetes, 76% were male, mean age (SD) was 67 (13) years. Incidences per 100 000 person years (standardized to the 2004 German population) in the diabetic and the non-diabetic populations: 176.5 (95% confidence interval 156.0-196.9) and 20.0 (17.0-23.1) in men, and 76.9 (61.9-91.8) and 13.4 (10.7-16.2) in women. Standardized relative risks: 8.8 (7.3-10.7) in men and 5.7 (4.3-7.6) in women. Attributable risks among exposed: 0.89 and 0.83 and population attributable risks 0.59 and 0.40, each in men and women, respectively. DISCUSSION: In our first German nationwide study, we found the relative risk of lower limb amputation in the diabetic compared to the non-diabetic to be lower than in earlier regional studies in Germany, supporting results of regional reductions of the excess amputation risk due to diabetes. A repetition of the study is warranted to further evaluate trends according to the St. Vincent goals.

[Evaluation of measures for improving patient management in diabetes]. / Evaluation von Massnahmen zur Verbesserung der Versorgung bei Diabetes.

In diabetes mellitus as a chronic disease the success of treatment depends largely on the patient's cooperation. Therefore, over the last ten years, a number of models for the improvement of diabetes care were developed in Germany. These models were described and evaluated in this study. Only measures focussed on structural and organizational features were included in the analysis. After identifying the 69 relevant methods, they were described in terms of structures, aims, target groups and results. In a second step, effectiveness, efficiency and generalizability of the models were analyzed. Some of the programs proved to be effective and should be implemented in the whole country. More attention should be paid to the prevention of complications. The strict separation between in-patient and out-patient care should be eliminated. Patients should be informed about results of quality monitoring. In many models, no appropriate evaluation was carried out. Therefore, this study emphasized the importance of a thorough evaluation of future models for the improvement of diabetes care. Instruments for evaluation should be determined already when the intervention is being planned.

[Epidemiology of blindness, especially in diabetes--overview of current studies]. / Epidemiologie von Erblindung, besonders bei Diabetes--Ubersicht über vorliegende Studien.

The main targets of the St. Vincent declaration of 1989 and of the WHO programme Health for All 2000 are reduction of loss of sight and especially of blindness associated with diabetes. However, hardly any data on blindness are available that describe a basic situation and would be suitable as a starting point for planning interventions and assessing them from the viewpoints of efficacy and efficiency. Only few studies have been conducted so far with detailed population-related data on the incidence and relative risks of blindness, as well as the associated mortality. The article reviews these studies and presents investigations that are presently being conducted in our department in this regard. The results obtained so far point to an increased incidence of blindness in peoples with diabetes, high relative and attributable risks especially in the young and middle-aged, and increased mortality rates subsequent to blindness, compared to the total population.

Cost-effectiveness of a structured treatment and teaching programme on asthma.

The purpose of this study was to perform a cost-effectiveness analysis of the structured treatment and teaching programme for patients with asthma (ATTP) at Düsseldorf University. We investigated whether the monetary benefits outweighed the costs of the intervention. Adult patients with moderate to severe asthma participated in a 5 day in-patient programme. Follow-up was 3 yrs. The incremental costs and benefits of the intervention, compared with standard treatment, were calculated. Costs were incurred by the hospitalization and by lost productivity. Compared to the year before the programme, (average reduction) days spent in hospital (5.2 days per patient per year), days of absence from work (18.4 days per patient per year), acute severe asthma attacks (3.8 attacks per patient per year), and physician consultations (2.3 visits per patient per month), decreased in the 3 yrs after the intervention. The programme produced net benefits of DM 12,850 (in 1991 German marks) per patient within 3 yrs. Within the health care sector, the net benefits were DM 5,900. Within 3 yrs, the paying bodies saved DM 2.70, and society as a whole saved DM 5 on each DM spent for the programme. We conclude that the intervention produced net monetary benefits. This result was stable over a wide range of variation of the outcome measures. Therefore, programme deserves implementation, not only for its demonstrated medical benefits but also for its economic savings.

Amputations and diabetes: a case-control study.

AIMS: Data concerning the relative risk of amputations in diabetic patients compared with the general population are scarce. Therefore, we carried out a case control study to quantify the relationship between diabetes and amputations. METHODS: In 20 hospitals in seven German cities and counties we obtained complete lists of non-traumatic lower limb amputations performed in 1990 and 1991. CONTROLS were selected from patients of the same surgical departments operated on in the same years. We drew a random sample of patients with procedures not likely to be associated with diabetes. Diabetic status was determined from patients' records in both cases and controls. We calculated age- and sex-specific and, using logistic regression, adjusted odds ratios (OR) and attributable risks. RESULTS: N = 2400, mean age 61.7 (SD 16.3) years. CASES: n = 729; 486 (66.7%) of them had diabetes. CONTROLS: n = 1671; 127 (7.6%) of them had diabetes. Adjusted OR: 18.2 (confidence interval (CI) 14.2-23.6). Adjusted attributable risk among exposed (ARE): 0.95 (CI 0.93-0.96). Adjusted population attributable risk (PAR): 0.62 (CI 0.57-0.66). CONCLUSIONS: This study has demonstrated a strong association between the risk of amputation and diabetes. The odds ratios and attributable risks for diabetic individuals are higher in the younger than in the older age groups. Population attributable risks are great. We conclude that the reduction of amputations in the general population will be achieved by improving foot care in people with diabetes.

Incidence of blindness in southern Germany between 1990 and 1998.

AIMS/HYPOTHESIS: A reduction of diabetes-related blindness by at least one third was declared a primary objective for Europe in 1989 (St. Vincent Declaration). To ascertain a potential change of incidence rates, we collected data on blindness in a German district (population: about 5 million) over 9 years. METHODS: We obtained complete lists of newly registered blindness-allowance recipients between 1990 and 1998 and population data on Württemberg-Hohenzollern, Germany. We estimated incidence rates of blindness in the general population and the diabetic population. To ascertain any time trend, we applied Poisson regression models. RESULTS: There were 6371 newly registered blindness allowance recipients (1990-1998). Of these 67% were women and 27 % had diabetes. Mean age was 71.7 years. Standardised results in the diabetic population (incidence rates per 100,000 person-years; standard: diabetic population; 95 % CI): 1990: 72 (61;82); 1991: 88 (76;100); 1992: 77 (67;88); 1993: 82 (71;93); 1994: 62 (53;72); 1995: 82 (71;93); 1996: 70 (60;80); 1997: 69 (59;79); 1998: 59 (49;68). The Poisson model estimated a 3 % decrease of incident blindness in the diabetic population for each year (Relative risk per year 0.97; CI: 0.95; 0.99). No significant change could be observed in the non-diabetic population (Relative risk: 0.99; CI: 0.98; 1.00). Relative risks for each year varied between sub-groups according to sex, diabetic status and cause of blindness between 0.94 and 1.01. CONCLUSION/INTERPRETATION: A slight reduction of incident blindness could be shown but a reduction by one third has not been reached. Several possible sources of bias in the data have to be considered.

Assessment of excess mortality in obesity.

Quantification of the excess mortality from all causes associated with obesity remains controversial. In this paper, 6,193 obese patients, those with a body mass index (weight (kg)/height (m)2 (BMI)) range of 25-74 kg/m2, recruited from 1961 to 1994 in Düsseldorf, Germany, were followed for a mean time of 14 (standard deviation, 8.2) years, yielding 87,179 observed patient-years. During the study period, 1,028 patients (16.6%) died. The entire cohort was grouped into approximate quartiles according to BMI: group 1, BMI from 25 to < 32; group 2, BMI from 32 to < 36; group 3, BMI from 36 to < 40; group 4, BMI > or = 40 kg/m2. The following risk ratios were estimated by means of Cox proportional hazards models using the lowest BMI group as reference category: group 2 for men, 1.02 (95% confidence interval 0.76-1.37); for women, 1.23 (95% confidence interval 0.96-1.58); group 3 for men, 1.50 (95% confidence interval 1.09-2.06); for women, 1.33 (95% confidence interval 1.03-1.73); and group 4 for men, 2.10 (95% confidence interval 1.53-2.88); for women, 2.25 (95% confidence interval 1.78-2.84). The following standardized mortality ratios were calculated by using the respective geographic area (the Federal State of North Rhine Westphalia) as reference population: group 1 for men, 1.26 (95% confidence interval 0.98-1.61); for women, 1.00 (95% confidence interval 0.81-1.23); group 2 for men, 1.31 (95% confidence interval 1.09-1.57); for women, 1.20 (95% confidence interval 1.02-1.40); group 3 for men, 1.92 (95% confidence interval 1.53-2.38); for women, 1.27 (95% confidence interval 1.07-1.50); and group 4 for men, 3.05 (95% confidence interval 2.47-3.73); for women, 2.31 (95% confidence interval 2.04-2.60). In addition to age, sex, and BMI, Cox proportional hazards models revealed systolic blood pressure, glucose intolerance, diabetes, and smoking as significant independent mortality risk factors, whereas cholesterol was not significant. In this prospective study of a large cohort of obese persons, morbid obesity (BMI of > or = 40 kg/m2) was a strong predictor of premature death. Excess mortality risks associated with gross obesity (BMI from 32 to < 40 kg/m2) were considerably lower than hitherto assumed; moderate degrees of obesity (BMI from 25 to < 32 kg/m2) were not significantly associated with excess mortality.

Blindness due to diabetes: population-based age- and sex-specific incidence rates.

Reducing the incidence of diabetic retinopathy and blindness was declared one of the main objectives in St Vincent. To date, hardly any valid data are available on the age- and sex-specific incidence of diabetes-related blindness. They are necessary, however, to evaluate intervention activities. Therefore, we used a population-based registry of blindness to calculate incidence of blindness due to diabetes. In one German district (Rhineland) we obtained complete lists of cases of blindness newly registered in 1990 and 1991 and coded as blind due to diabetes (n = 589). We estimated age-specific incidence rates in the entire as well as in the diabetic population. Incidence rates of blindness due to diabetes (100,000(-1) * year(-1)), standardized to the West-German population, were 3.2 (CI 95%: 2.9;3.4) in the entire population and 60.5 (CI 95%: 45.7;75.4) in the diabetic population. Incidence rates in the diabetic population showed a peak between 20 and 40 years of age, probably due to complications of Type 1 diabetes. Incidence was higher in diabetic women than in diabetic men (p < 0.05 at ages > or =40 years). Repeating the study will detect a decrease in the incidence of blindness due to diabetes by one-third with over 99% power.

Effect of age on excess mortality in obesity.

CONTEXT: The effect of age on excess mortality from all causes associated with obesity is controversial. Few studies have investigated the association between body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters), age, and mortality, with sufficient numbers of subjects at all levels of obesity. OBJECTIVE: To assess the effect of age on the excess mortality associated with all degrees of obesity. DESIGN: Prospective cohort study. SETTING AND PARTICIPANTS: A total of 6193 obese patients with mean (SD) BMI of 36.6 (6.1) kg/m2 and mean (SD) age of 40.4 (12.9) years who had been referred to the obesity clinic of Heinrich-Heine University, Düsseldorf, Germany, between 1961 and 1994. Median follow-up time was 14.8 years. MAIN OUTCOME MEASURE: All-cause mortality through 1994 among 6053 patients for whom follow-up data were available (1028 deaths) analyzed as standardized mortality ratios (SMRs) using the male-female population of the geographic region (North Rhine Westphalia) as reference. RESULTS: The cohort was grouped into approximate quartiles according to age (18-29, 30-39, 40-49, and 50-74 years) and BMI (25 to <32, 32 to <36, 36 to <40, and > or =40 kg/m2) at baseline. The SMRs showed a significant excess mortality with an SMR for men of 1.67 (95% confidence interval, 1.51-1.85; P<.001) and an SMR for women of 1.45 (95% confidence interval, 1.34-1.57; P<.001). The excess mortality associated with obesity declined with age. For men, the SMRs of the 4 age groups were 2.46, 2.30, 1.99, and 1.31, respectively; for women, they were 1.81, 2.10, 1.70, and 1.26, respectively (Poisson trend test, P<.001). The SMRs increased with BMI but, within each BMI group, the SMRs decreased with age. The lowest SMRs (for men, 1.01; for women, 0.91) were obtained for patients older than 50 years with BMIs of 25 to less than 32 kg/m2. Thus, older men and women at a BMI range of 25 to less than 32 kg/m2 had no excess mortality. The highest SMRs (for men, 4.22; for women, 3.79) were calculated for the patients aged 18 to 29 years with a BMI of 40 kg/m2 or higher. CONCLUSIONS: In this large cohort of obese persons, risk of death increased with body weight, but obesity-related excess mortality declined with age at all levels of obesity.

Social status and the quality of care for adult people with type I (insulin-dependent) diabetes mellitus--a population-based study.

UNLABELLED: The objective of this study was to assess the degree of diabetes care and education achieved for Type I (insulin-dependent) diabetes mellitus at the community level in relation to social status and to elucidate potential pathways that mediate any social class gradient. A population-based sample of 684 adults with Type I diabetes (41% women, mean +/- SD age 36 +/- 11, diabetes duration 18 +/- 11 years) in the district of North-Rhine (9.5 million inhabitants), Germany, were examined in their homes using a mobile ambulance. RESULTS: HbA1c (normal 4.3-6.1%) 8.0 +/- 1.5%, incidence of severe hypoglycaemia (injection of glucose or glucagon) 0.21 cases per patient-year; 62% of patients had participated in a structured group treatment and teaching programme for intensification of insulin therapy; 70% used 3 or more insulin injections per day, 9% were on continuous subcutaneous insulin infusion; 91% reported to have had measurements of HbA1c during the preceding year, and 80% to have had an examination of the retina by an ophthalmologist. Care was insufficient with respect to the quality of blood pressure control (70% of patients on antihypertensive drugs had blood pressure values > or = 160/95 mmHg), patient awareness of proteinuria/albuminuria (27% of patients had not heard about it) and prevention of foot complications (only 42% with a diabetes duration over 10 years had remembered to have a foot examination during the preceding 12 months). There was a pronounced social gradient with respect to micro- and macrovascular complications (prevalence of overt nephropathy 7 vs 20% for highest vs lowest quintiles of social class [OR 3.5, 95% CI 1.6-7.5, p = 0.002]) and diabetes-specific quality of life. HbA1c, blood pressure and smoking accounted for part of the association between social class and microvascular complications. The social class gradient was not due to inequality to access to health services, but to lower acceptance among low social class patients of preventive and health maintaining behaviour. In conclusion, achieved standards of care are high with respect to the implementation of intensified treatment regimens, the level of patient education achieved, treatment control and eye care, whereas areas for improvement are blood pressure control and preventive measures for foot care. A substantial social gradient in diabetes care persists despite equal access of patients to health services.

Effectiveness and cost-benefit analysis of intensive treatment and teaching programmes for type 1 (insulin-dependent) diabetes mellitus in Moscow--blood glucose versus urine glucose self-monitoring.

In a prospective controlled trial the effects of a 5-day in-patient treatment and teaching programme for Type 1 (insulin-dependent) diabetes mellitus on metabolic control and health care costs were studied in Moscow. Two different intervention programmes were compared, one based upon urine glucose self-monitoring (UGSM, n = 61) and one using blood glucose self-monitoring (BGSM, n = 60). Follow-up was 2 years. A control group (n = 60) continued the standard treatment of the Moscow diabetes centre and was followed-up for 1 year. Costs and benefits with respect to hospitalizations and lost productivity (according to average wage) were measured in November 1992 rubles (Rb.), with respect to imported drugs and test strips in 1992 German marks (DM). In the intervention groups there were significant decreases of HbA1 values [UGSM: 12.5% before, 9.4% after 1 year, 9.2% after 2 years (p < 0.0001); BGSM: 12.6% before, 9.3% after 1 year, 9.2% after 2 years (p < 0.0001) compared to no change in the control group (12.2% before, 12.3% after 1 year)], and of the frequency of ketoacidosis. The frequency of severe hypoglycaemia was comparable between the UGSM (10 cases during 2 years), BGSM (10 cases during 2 years), and the control group (8 cases during 1 year).(ABSTRACT TRUNCATED AT 250 WORDS)

Venous incompetence in erectile dysfunction: evaluation with color-coded duplex sonography and cavernosometry/-graphy.

The purpose of this study was to assess the accuracy of multi-parameter measurements with color-coded duplex sonography (CCDS) for the diagnosis of venous leakage in patients with erectile dysfunction. Sixty patients with repeated unsatisfactory reactions after intracavernous injection of vasoactive substances underwent CCDS. Following intracavernous injection of prostaglandin E1, peak systolic velocity (PSV), enddiastolic velocity (EDV), time averaged velocity (TAV), resistance index (RI), and pulsatility index (PI) were measured in the cavernous arteries over 30 min (one measurement per minute). The results were compared with independent measurements based on dynamic pharmaco-cavernosometry/cavernosography (DPCC). Dynamic pharmaco-cavernosometry/cavernosography revealed venous leakage in 33 patients. Of 48 patients with normal PSV ( > 25 cm/s), 25 had veno-occlusive dysfunction and the remainder presented normal venous function. No statistically significant differences between these groups were found in EDV, RI, and PI measurements. In contrast, differences in TAV were significant between patients with (mean 9.4 +/- 4.6 cm/s) and without venous leakage (mean 5.5 +/- 2.2 cm/s; p = 0.001). Analysis of relative frequencies revealed a broad overlap of EDV, TAV, RI, and PI measurements between both groups. Sensitivities and specificities determined from receiver-operating-characteristic curves were > 80 % and > 50% for a TAV threshold of 5 cm/s, and an RI threshold of 1.0. Measurements of EDV, TAV, RI, and PI in patients with repeated unsatisfactory reactions on intracavernous prostaglandin injection are poor predictors of venous leakage and should not replace DPCC in the investigation of vasculogenic impotence.