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Nocturnal electrobioimpedence volumetric assessment in diabetic men with erectle dysfunction before and after Tadalafil intake
Abstract
Nocturnal electrobioimpedance volumetric assessment (NEVA) is a procedure that can measure penile volume changes together with the number and duration of nocturnal erectile events. This study was conducted to evaluate the different NEVA patterns in diabetic patients with erectile dysfunction (ED), and demonstrate the extent to which tadalafil may affect the characteristics of nocturnal penile erections in these patients. Therefore, 38 patients with noninsulin-dependent diabetes and ED participated in this study. They were assessed with history intake including evaluation by the abridged five-item version of International Index of Erectile Function, clinical and psychiatric assessment and NEVA for three consecutive nights where placebo was given on the second night and tadalafil on the third night. In all, 14 potent males were taken as a control group. Data were analyzed using t-test. Results showed normal patterns in only six (16%) patients (central organic group), while abnormal patterns were observed in the remaining 32 (84%) patients (peripheral organic group). These abnormal patterns showed significant decrease in both the number (P=0.0001) and duration (P=0.03) of erectile events compared to those of controls. The percentage of penile blood volume change over baseline also decreased significantly (P=0.0002) relative to controls. Veno-occlusive dysfunction was the main pathology (23 patients, 72%) as suggested by NEVA. Tadalafil did not significantly change basal nocturnal penile tumescence results in either the central organic or control groups, but it did so significantly in the peripheral organic group (P=0.02 for duration change and P=0.01 for % blood volume change). In conclusion, NEVA may suggest some evidence about the pathophysiology of an underlying vasculogenic cause, thus directing towards the next specific step needed for a precise diagnosis. Tadalafil improves nocturnal erections in diabetic patients with peripheral but not central organic impotence.
... Computer algorithms enable the calculation of penile length and cross-sectional area changes per unit time. The results obtained through NEVA ® can be used to identify some of the causes of ED, which makes it a powerful nocturnal penile tumescence device that is used in SRE research [55][56][57][58]. However, the NEVA ® cannot measure the crucial variable of rigidity, which is the key parameter for sexual penetration. ...
For many males, sexual function holds significant value in determining their quality of life. Despite the importance of male erectile function, no quantitative method to measure it accurately is currently available. Standardized assessment methods such as RigiScan™, International Index of Erectile Function (IIEF-5), and the stamp test are used to evaluate sexual function, but those methods cannot repetitively and quantitatively measure erectile function. Only direct measurement can quantitatively assess the shape of an erect penis. This paper presents the essential requirements for developing an ideal measurement method for penile erection. It also introduces current approaches for diagnosing male sexual function and reviews ongoing research to quantitatively measure erectile function. The paper further summarizes and analyzes the advantages and disadvantages of each method with respect to the essential requirements. Finally, the paper discusses the future direction toward the development of Penile Erection Morphometry.
... With tumescence, In patients with veno-occlusive dysfunction, NPTE assessment reveals a lower volumetric change with erection and fewer erectile episodes although precise definitions have yet to be determined, and yet again accounting for the presence of arterial insufficiency remains problematic. 21 Current evidence suggests a diagnostic correlation with standard NPT in the region of 84%. 22 Dynamic infusion cavernosography and cavernosometry (DICC) has previously been a widespread and popular investigation for patients suspected of suffering from veno-occlusive dysfunction; it is, however, invasive and its unknown positive predictive value, lack of results standardisation and poor specificity hinder its acceptance and use. ...
Congenital venous leak or veno-occlusive dysfunction is an important cause of vasculogenic erectile dysfunction, posing a significant challenge to urologists. To date no medical therapy exists for the treatment of this condition, whilst surgical management options are based on resection or ligation of the offending venous drainage with a significant decline in efficacy with follow-up exceeding 12 months, perhaps as a consequence of collateral drainage.
This review article highlights the importance of veno-occlusive dysfunction. We discuss the pathophysiology, investigations and the required treatment.
Level of evidence: Not applicable for this multicentre audit.
... Use of the NEVA at home was rapidly applied to ED patients, and it was concluded that it was possible to distinguish arterial insufficiency from veno-occlusive dysfunction using this device [82]. Additionally, Salama suggested that NEVA may have the potential to provide some evidence regarding the pathophysiology of an underlying vasculogenic cause [83]. A comparison with color Doppler ultrasonography demonstrated that results obtained using the NEVA device were well correlated with the function of penile arteries and veins, and it was concluded that NEVA may identify the etiology of ED to some extent [84]. ...
Over the past decades, sleep-related erection and rigidity monitoring has been used to differentiate psychogenic from organic erectile dysfunction (ED), due to the involuntary nature of erections in sleep. This study retrospectively reviewed all available literature focusing on sleep-related erection and rigidity monitoring through a systematic PubMed search. To date, there are mainly seven methods and their modifications, including: sleep laboratory testing, the mercury strain gauge, the stamp test, the erectometer, the Snap gauge, the RigiScan, and nocturnal electrobioimpedance volumetric assessment. This study analyzes and summarizes the advantages and limitations of seven monitoring methods. This study indicates that both of the above methods possess the capacity to assess erectile quality and provide guidance to the diagnosis, etiology, and differential diagnosis of ED. However, some limitations still exist for the application. New devices which can continuously monitor kinds of variables, including sleep-related erection, axial and radial rigidity, and oxygen saturation are needed.
... These impedance changes are converted to data. The device records the times, duration, and particularly blood volume increase of NPT events [7]. The standard of diagnosis is as following: >5 Normal Rigiscan is partial to be used in testing variation of hardness of penile erection. ...
... In brief, the property of electrobioimpedance changes with minute variations in blood flow. Consequently, penile volumetric changes can be calculated from changing measures of impedance (Salama, 2004). Penile blood volume is computed from NEVA data, including the cross-sectional area and length of the penis. ...
Previous studies established the efficacy of once-daily tadalafil for men with erectile dysfunction. However, no trial has focused on the effects of such treatment on men without previous experience using oral phosphodiesterase type 5 (PDE5) inhibitors. Subjects were randomized (2:1) to once-daily tadalafil 5 mg (with possible down-titration to 2.5 mg; n = 146) or placebo (n = 69) for 12 weeks. Among 215 subjects (mean age = 52 years), once-daily tadalafil treatment resulted in 61.7% of study participants reporting their ability to achieve and maintain erections being much better or very much better (vs. 21.7% on placebo; P < .001). Tadalafil significantly improved treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS; P < .001 vs. placebo at endpoint) and psychosocial outcomes on the Self-Esteem and Relationship (SEAR) questionnaire (least-squares mean difference in SEAR total score change from baseline = 11.8 [95% CI = 5.4-18.2; P < .001 vs. placebo]). Subjects receiving once-daily tadalafil also experienced a higher proportion of daily self-reported spontaneous morning erections at endpoint (58.7%) compared to placebo (42.2%; P < .001 for the between-treatment difference in changes from baseline). However, no significant differences in parameters of endothelial dysfunction (including biomarkers and peripheral arterial tonometric measures) or nocturnal erections as recorded by the nocturnal electrobioimpedance volumetric assessment were observed between treatment groups. Tadalafil was well tolerated; adverse events included back pain, headache, and dyspepsia. These findings may contribute to a more comprehensive understanding of once-daily tadalafil's effects on PDE5-inhibitor-naive men.
Objective: To evaluate the Clinical Significance of repeated nocturnal electrbioimpedance volumetric assessment and IIEF-5 on erectile dysfunction patients. Methods: Total of 90 out-patients with erectile dysfunction was examined in the study. Self-Grading was performed by using the IIEF-5 questionnaire.and then three consecutive nights of home NEVA monitoring were undertaken in all the patient. And the results were retrieved and analyzed. Results: Fifty-two(58%) cases showed no organic diseases in the penis. There was significant difference between the first record and results of repeated test existed (P<0.05) including the number of erectile events, percentage of volume change over baseline and the longest erectile event duration. The change of the blood volume during penis erection is positive correlation with IIEF-5 scores. Conclusion: The repeated NEVA combined with IIEF-5 can reduce data error in NEVA results and improve the reliability in diagnosis of ED. Therefore, this examination strategy showed great advantage in differentiated diagnosis of ED especially in patients with un-accurate results in routine NEVA test.
Spontaneous nocturnal erections in men are a well-known phenomenon whose physiology however is not yet really understood. The measurement of nocturnal erections has gained clinical relevance for the diagnosis of erectile dysfunction because it allows an objective and quantitative assessment of the erectile capacity. A decisive advantage compared to other diagnostic tests carried out during wakefulness is the exclusion of psychological factors to a great extent. Thus, an evaluation of the organic component of an erectile dysfunction is possible. Regarding the interpretation of nocturnal erection records, various factors possibly influencing the results must be considered; this is particularly relevant if the method is applied in forensic evaluations. Registration of at least one normal nocturnal erection indicates that the penile structures are intact and that the organic requirements on the peripheral level for developing an erection are fulfilled. Abnormal nocturnal erection patterns can only be assessed correctly on the basis of a polysomnography carried out simultaneously. In case of an undisturbed sleep profile, missing or clearly diminished nocturnal erections point to organic causes of the erectile dysfunction. With the availability of very effective noninvasive treatment options for erectile dysfunction that are independent of aetiology, nocturnal erection measurement is not part of the routine diagnosis; rather, it is reserved for selected cases where the exact determination of the underlying causes is relevant.
A wide variety of risk factors contribute to erectile dysfunction (ED). Many of these risk factors are treatable yet go unrecognized.
Further, many of the treatments of these risk factors have also been implicated in causing the disease. Thus, the treatment
of ED may be a complicated issue for the general practitioner. The majority of this chapter focuses on the correlation between
cardiovascular disease and erectile dysfunction. A major benefit of screening for ED is that it may lead to early diagnosis
of subclinical cardiovascular disease, alerting the clinician to potential treatment intervention in these patients.
KeywordsCardiovascular disease and ED-Etiology of ED-Atherosclerosis-Obesity and ED-Diabetes and ED-Depression and ED
Background:
Erectile dysfunction is a common multi-factorial complication of diabetes mellitus. Numerous strategies have been tried to overcome this diabetic complication. In recent years, phosphodiesterase type 5 (PDE-5) inhibitors have been introduced in the management of erectile dysfunction.
Objectives:
The objective of this review was to assess the effect of PDE-5 inhibitors on the management of erectile dysfunction in diabetic men.
Search strategy:
Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library.
Selection criteria:
Randomised controlled trials, in which treatment with PDE-5 inhibitors was compared to control, in diabetic patients with erectile dysfunction.
Data collection and analysis:
Two reviewers independently extracted data and assessed trial quality.
Main results:
Eight randomised controlled trials were identified. A total 976 men were allocated to receive a PDE-5 inhibitor and 741 were randomised to the control groups. Overall, 80% of the participants suffered from type 2 diabetes mellitus. The weighted mean difference (WMD) for the International Index of Erectile Function (IIEF) questions 3 and 4 (frequency of penetration during and maintaining erection to completion of intercourse) was 0.9 (95% CI 0.8 to 1.1) and 1.1 (95% CI 1.0 to 1.2) at the end of the study period, in favour of the intervention group. The WMD for the IIEF erectile dysfunction domain at the end of the study period was 6.6 (95% CI 5.2 to 7.9) in favour of the PDE-5 inhibitors arm. The relative risk (RR) for answering "yes" to a global efficacy question ( "did the treatment improve your erections?") was 3.8 (CI 95% 3.1 to 4.5) in the PDE-5 inhibitors compared with the control arm. The WMD between the percentage of successful attempts in the PDE-5 inhibitors and in the control arm was 26.7 (95% CI 23.1 to 30.3). Mortality was not reported in any of the included trials. Adverse cardiovascular effects were reported in one study. Headache was the most frequent adverse event reported, flushing was the second most common event, with upper respiratory tract complaints and flu like syndromes, dyspepsia, myalgia, abnormal vision and back pain also reported in a descending order of frequency. The overall risk ratio for developing any adverse reaction was 4.8 (CI 95% 3.74 to 6.16) in the PDE-5 inhibitors arm as compared to the control.
Authors' conclusions:
Sufficient evidence exists that PDE-5 inhibitors form a care that improves erectile dysfunction in diabetic men.
An abridged five-item version of the 15-item International Index of Erectile Function (IIEF) was developed (IIEF-5) to diagnose the presence and severity of erectile dysfunction (ED). The five items selected were based on ability to identify the presence or absence of ED and on adherence to the National Institute of Health's definition of ED. These items focused on erectile function and intercourse satisfaction. For 1152 men (1036 with ED, 116 controls) analyzed, a receiver operating characteristic curve indicated that the IIEF-5 is an excellent diagnostic test. Based on equal misclassification rates of ED and no ED, a cutoff score of 21 (range of scores, 5-25) discriminated best (sensitivity=0.98, specificity=0. 88). ED was classified into five severity levels, ranging from none (22-25) through severe (5-7). Substantial agreement existed between the predicted and 'true' ED classes (weighted kappa=0.82). These data suggest that the IIEF-5 possesses favorable properties for detecting the presence and severity of ED.
The traditional distinction between organic and psychogenic erectile dysfunction (ED) was maintained in the recent report of the Nomenclature Committee of the International Society for Sexual and Impotence Research. Among the major problems with this distinction are that it is based on an obsolete view of mind-body distinctions, does not take into account knowledge of the neurobiology of 'psychological' disorders, disregards the fundamental meaning of 'psychosomatic,' is too often diagnosed by exclusion, and may imply to the patient that his ED is 'all in the mind.' As a result, the distinction has become counterproductive in the diagnosis, classification, and treatment of ED, and in research into the causes of ED. An alternative taxonomy, based on that proposed by the Nomenclature Committee, reclassifies as organic several of the causes of ED now considered to be psychogenic, and considers others as situational ED, a class reserved for episodic occurrences of ED clearly due to particular attributes of sexual encounters.
Nocturnal penile tumescence is used commonly to evaluate erectile dysfunction. However, this test is not equivalent to erection since it measures circumferential change only rather than the crucial variable of penile rigidity. We present a new concept in the measurement of penile rigidity the capability of a patient during sleep to break a band furnished with pre-set snap-gauges with different release-force constants applied around the penile shaft. The snap-gauge band was tested simultaneously with the recording of nocturnal penile tumescence measuring penile rigidity rather than tumescence.
During the last two decades, significant advances have been made in the understanding of male sexual dysfunction. Concomitantly, a marked increase in both clinical and research activity in the field of male erectile dysfunction has led to a better evaluation and more treatment options. The prevalence and incidence are dependent on the definitions used, the diagnostic tolls, and the treatment options. Using standard definitions as suggested by the NIH Consensus Conference and improving our diagnostic and treatment options will have a major impact on the epidemiology of ED. A summary of the risk factors for ED is presented in Table 3. Still more epidemiologic research is essential to further understand the distribution as well as the prevalence of ED in certain ethnic groups, chronic conditions, and as a result of surgery and trauma. These studies will help us improve our diagnostic skills as well as our therapeutic options.
Three-hour oral glucose tolerance tests (GTTs) were performed for 58 men with secondary impotence (SI), 63 with normal sexual function (NL), and 69 with premature ejaculation (PRE). All were apparently nondiabetic. Diagnoses of diabetes and impaired glucose tolerance were based on serum glucose levels during GTT as recently defined by the National Diabetes Data Group. Covariance analysis corrected for weight and age differences. Mean glucose levels in patients with SI were significantly higher at one and two hours after glucose ingestion than in the other groups. Seven patients with SI (12.1%) were found to have diabetes. The three groups did not differ notably in frequency of impaired glucose tolerance. Inorganic serum phosphate levels were lower for the SI group. The high frequency of diabetes in subjects with SI who have no diabetic symptoms (12.1%) suggests that localized neuropathy or penile ischemia may produce impotence in otherwise asymptomatic patients.
(JAMA 244:2430-2432, 1980)
Sixty diabetic males complaining of impotence were administered a structured interview and completed nocturnal penile tumescence (NPT) monitoring to categorize their impotence as either organic, psychogenic, or undetermined. A summary score of seven sexual symptoms was found to be effective in differentiating organic from psychogenic impotence. By relying upon these seven sexual symptoms as a screening test, 38% of male impotent diabetics can be spared the expense of NFT monitoring, since the outcome of such monitoring can be predicted from the summary score of these seven symptoms. The correlation between the seven sexual symptoms and the subjects' NPT monitoring results was 0.78, accounting for 61% of the variance. Therefore the seven sexual symptoms can be useful in predicting NPT monitoring results before the monitoring is completed. The sensitivity, specificity, and efficiency of the seven sexual symptoms is discussed, as well as the cost efficiency of utilizing this screening device.
The authors conducted a study of nocturnal penile tumescence (NPT) in 125 healthy males aged 3 to 79 by means of EEG recordings to provide normative data on how general the phenomenon is, its range of charateristics, and how it is related to man's sexual function. The results indicate that NPT occurs consistently in a healthy male population, that its expression is significantly affected by age, that it is related to stage of psychosexual development, and that it is worthy of further investigation. Clinical experience indicates that it is a useful, objective method of discriminating among various types of biogenic and psychogenic impotence.
A study was conducted to assess the discriminant validity of patient responses to a questionnaire in distinguishing between organic and psychogenic erectile dysfunction. A total of 56 urologist-referred veterans slept for 3 nights in a sleep laboratory for nocturnal penile tumescence recording. Based on nocturnal penile tumescence results 48 patients were assigned to an organic group and the remaining 8 were assigned to a psychogenic group. A discriminant function analysis of questionnaire responses yielded a highly significant discriminant function [chi-square (19) equals 63.88, p less than 10(-6)], and all 56 patients were classified correctly into the nocturnal penile tumescence-defined organic and psychogenic groups. It was concluded that verbally reported data contain diagnostically meaningful information and that such information can compare favorably with information collected through standard laboratory-based nocturnal penile tumescence techniques.
A new technique for continuous recording of penile rigidity and tumescence has been developed. This methodology has been utilized in initial studies to define erectile function in both normal and impotent males. Accurate recording of tumescence and rigidity have been utilized to document the decline in erectile function associated with organic impotence.
We evaluated 31 male diabetics for sexual dysfunction. Patients were examined by an endocrinologist, psychologist or psychiatrist, urologist and neurophysiologist. Evaluation was done by penile blood pressure, pudendal nerve latency, psychologic testing and laboratory tests, including serum testosterone levels. Mean patient age was 53 years and the average onset of sexual dysfunction was 6 years after the diagnosis of diabetes. Results showed that 68 per cent of the patients had evidence of vascular occlusion, 26 per cent had neurologic abnormalities, 19 per cent had low plasma testosterone levels and 38 per cent had relevant psychological problems, although the condition was considered primarily psychogenic in only 19 per cent. Of those patients with abnormal nerve latencies 86 per cent had abnormal Doppler penile systolic pressures, while only 28 per cent of the patients with abnormal penile pressures had abnormal neurologic findings. These data suggest that vascular occlusion is the most prevalent abnormality in impotent diabetics and may predate neurologic abnormalities. The diabetics were divided into 2 groups, insulin-dependent and insulin-nondependent patients. A higher incidence of vascular lesions was found in insulin-dependent diabetics (83 versus 57 per cent), suggesting that vascular pathological conditions are related to severity of the diabetes. Although most diabetics have a vascular etiology for impotence one must remember that other causes may be present and that a thorough investigation is necessary.
Thirty subjects, who were between the ages of 24 and 60 years and were free of sleep disorders, were evaluated for impotency by use of polysomnograms recorded over 2 consecutive nights. No statistical differences between the first and second nights' recordings were found in latency to rapid eye movement and stage 4 sleep, sleep efficiency, and movement time with or without awakening. No differences were noted in times spent in different sleep stages, nor between the first 3 h and the second 3 h of sleep across both nights of polysomnography. This confirms previous findings that questioned the efficacy of the first night effect. This study also emphasizes the need to compare sleep disorder patients with matched normal controls.
Nocturnal penile tumescence is used commonly to evaluate erectile dysfunction. However, this test is not equivalent to erection since it measures circumferential change only rather than the crucial variable of penile rigidity. We present a new concept in the measurement of penile rigidity--the capability of a patient during sleep to break a band furnished with pre-set snap-gauges with different release-force constants applied around the penile shaft. The snap-gauge band was tested simultaneously with the recording of nocturnal penile tumescence measuring penile rigidity rather than tumescence.
Clinical, sexual, and laboratory evaluations were made on 47 impotent diabetics. All patients were given a Doppler PAPS examination and a neurologic assessment of the penis (BCRL and/or CMG). Nerve conductivity tests of the legs were also administered to most patients. The groups were classified as to whether they were insulin or noninsulin dependent. Abnormalities of penile arterial flow were detected in 95.7 per cent of all the patients. Penile arterial occlusions without associated penile neuropathies occurred in 61.7 per cent. Penile neuropathies were found in 34 per cent, and all were associated with varying degrees of penile arterial obstruction. Diabetics who were dependent on insulin showed a high frequency of vascular pathologies and a 12 to 15 per cent higher rate of penile neuropathies than the group not dependent on insulin. Our study suggests that obstruction of penile arteries is the primary factor in erectile dysfunction of diabetics. Those impotent diabetics without any overt penile nerve damage might be good candidates for revascularization procedures.
A stamp technique was developed to detect complete nocturnal erections for the evaluation of impotence. The test correctly detected complete nocturnal erections in 22 potent men and absence of complete nocturnal erections in 11 impotent men (P value under 0.001). This is a simple, useful screening test for organic impotence.
Three-hour oral glucose tolerance tests (GTTs) were performed for 58 men with secondary impotence (SI), 63 with normal sexual function (NL), and 69 with premature ejaculation (PRE). All were apparently nondiabetic. Diagnoses of diabetes and impaired glucose tolerance were based on serum glucose levels during GTT as recently defined by the National Diabetes Data Group. Covariance analysis corrected for weight and age differences. Mean glucose levels in patients with SI were significantly higher at one and two hours after glucose ingestion than in the other groups. Seven patients with SI (12.1%) were found to have diabetes. The three groups did not differ notably in frequency of impaired glucose tolerance. Inorganic serum phosphate levels were lower for the SI group. The high frequency of diabetes in subjects with SI who have no diabetic symptoms (12.1%) suggests that localized neuropathy or penile ischemia may produce impotence in otherwise asymptomatic patients.
Patients referring to the Urology and/or Endocrinology Departments of Ankara Medical School with complaints of diabetes mellitus (DM) and related complications were evaluated during the last year. A detailed history was obtained and all of the patients were questioned especially about sexual function problems. Following this evaluation, all patients were divided into two main groups, i.e. patients with sexual disorders, and those with normal sexual function. Factors such as BPH, cerebrosclerosis and other important vascular-neurologic pathologies which may play a role in the etiology of impotence were excluded from the study and 38 patients with sexual dysfunction and 15 with normal sexual activities have undergone further evaluation. Following routine blood and urine analyses, serum hormone levels (testosterone, FSH, LH, prolactin) were determined. Penile color-flow doppler analysis, cavernosometry, cavernosography, bulbocavernous reflex latency time and evaluation of somatosensory evoked potentials were performed. Additionally, all patients were evaluated from the psychiatric aspect using the Hamilton depression scale and MMPI questionnaire. The presence of vascular or neurologic pathology in 89.4% of our patients and of both pathologies in 39.4% of the patients, indicated the importance of multifactorial evaluation of diabetic impotence in order to plan a complete and efficient therapy program.
The contribution of organic and psychogenic factors in the aetiopathogenesis of impotence was studied in a large number of diabetic males, to develop an algorithm for its management. We examined 110 consecutive patients who were referred to the Impotence Clinic of the Diabetes Centre. All patients were initially evaluated by a diabetologist and then underwent psychosexual assessment by a specialized psychiatrist. Patients with primarily organic disease were referred to a urologist for further management while those with psychogenic impotence received psychosexual counselling. Peripheral neuropathy was present in 71 (65%) and two or more autonomic tests were abnormal in 22 (20%) patients. Neuropathy was the only cause detected in 29 (27%) patients, the main cause in 22 (20%), and contributing, but not the main factor, in 20 (18%). Psychogenic factors were the only cause detected in 12 (11%) patients, the main cause in 26 (24%) and contributed in 19 (17%). Marital disharmony, medical treatment, and peripheral vascular disease were the main aetiopathogenic factors in the remaining cases. Psychosexual counselling resulted in successful intercourse in 17 (60%) out of the 24 treated patients and papaverine injections in 31 (61%) out of 56 treated patients. It is concluded that although organic factors are mainly responsible for the development of impotence in diabetic males, psychological factors contribute significantly and psychosexual assessment and counselling are essential adjuncts to its management. Treatment with papaverine injections is generally inexpensive and effective to overcome the multifactorial causes of erectile dysfunction in this population. An algorithm which may facilitate the investigation and treatment of impotent diabetic males is proposed.
Because of its implications for possible therapy, the ability to establish a diagnosis of erectile dysfunction (ED) solely on the basis of history and physical examination has been a matter of controversy. The determination of the etiology of ED based on history and physical examination is evaluated in this present study.
Consecutive patients presenting for evaluation of ED were evaluated by careful history, physical examination, psychologic evaluation, and RigiScan monitoring. They were then stratified into either organic or psychogenic groups based on each of these modalities. These diagnoses were then compared to a final diagnosis obtained through additional testing.
History and physical examination had a 95% sensitivity but only a 50% specificity in diagnosing organic ED. The accuracy rates of history and physical examination in diagnosing ED were 80% and 60%, respectively.
A multifaceted comprehensive approach is required to evaluate fully and to diagnose ED.
Duplex ultrasound is used commonly to evaluate vascular function in impotent men. There is evidence, however, that some men with normal vascular function may have falsely abnormal duplex ultrasound results because of suppression of response to pharmacological stimulation due to anxiety. We performed a prospective blinded study of 40 impotent men comparing duplex ultrasound to a formal nocturnal penile tumescence evaluation. Duplex ultrasound was done with a standard 10 MHz. color Doppler unit after intracorporeal pharmacological stimulation. Nocturnal penile tumescence was performed at a sleep laboratory, and included measurements of penile circumference, axial rigidity, arterial pulsations, and direct patient and observer evaluation of erections.
In a study of 23 diabetic men complaining of impotence, completion of physical tests, self-report psychometric testing, a rating of marital intimacy, and a semi-structured interview revealed that, of ten patients found to be at risk of psychogenic impotence secondary to marital or psychiatric morbidity, five were thought to have adequate erectile response and to have a psychogenic component to their problem. This seems to show high sensitivity, if not specificity, of the self-report questionnaires.
Seventy-eight male diabetics with sexual dysfunction were evaluated by a thorough history, general physical, psychological, neurological and urological examinations, routine laboratory tests, and a duplex ultrasound scan with intracavernous injection of prostaglandin E1 (PGE1). The mean patient age was 55.9 years, and the average onset of sexual dysfunction was 10.0 years after the diagnosis of diabetes. Sixty-eight patients (87.2%) had moderate or severe cavernous arterial insufficiency. Older patients and those having a longer duration of diabetes had a higher incidence of cavernous arterial insufficiency. Cigarette smoking, hypertension, and alcohol abuse were also related to cavernous arterial insufficiency. There was no significant difference in cavernous arterial insufficiency between the insulin-dependent and the insulin-nondependent groups. There were significant differences of diameters and peak blood flow velocities of cavernous arteries between 78 diabetic impotent patients and 10 controls. These findings strongly suggest that the cavernous arterial insufficiency is closely related to the diabetic impotence. In addition, the prevalence of cavernous arterial insufficiency increases with age, duration of diabetes, cigarette smoking, hypertension and alcohol abuse, but it is not definitely correlated with the type of diabetes management.
The purpose of this report is to examine the prevalence of erectile dysfunction and relationships to other characteristics in men with younger-onset diabetes.
In a population-based cohort study in southern Wisconsin, prevalence of erectile dysfunction was measured based on self reports in men who were 21 years of age or older, were < 30 years of age at diagnosis of diabetes, had 10 or more years of diabetes, and were taking insulin (n = 365).
Of the study group, 20% reported a history of erectile dysfunction. The prevalence of erectile dysfunction increased with increasing age (from 1.1% in those 21-30 years of age to 47.1% in those 43 years of age or older, P for trend < 0.0001) and with increasing duration of diabetes (P for trend < 0.0001). Erectile dysfunction was associated with presence of severe diabetic retinopathy, a history of peripheral neuropathy, amputation, cardiovascular disease, a higher glycosylated hemoglobin, use of antihypertensive medications, and higher BMI.
These data suggest that tighter glycemic control and careful selection of antihypertensive medications might prove beneficial.
This study assessed characteristics of sexual dysfunction in sleep apnea and the efficacy of treatment with continuous positive airway pressure (CPAP). Twenty-two men with sleep apnea syndrome and also sexual dysfunction served as subjects in this study. Tests included physical, psychological, neurological, and penile vascular examinations, along with polysomnography, nocturnal penile tumescence (NPT), and penile rigidity. All patients clinically had a history of snoring and difficulty getting and maintaining erections. Results indicate that erectile dysfunction in patients with sleep apnea could be related to patient's age and chronic cerebral hypoxia due to apnea. Treatment with CPAP relieved erectile dysfunction in one-third of these patients.
Electrobioimpedance volumetric assessment is based on the principle of delivering a constant, nondetectable alternating current to a tissue segment. A potential difference measured between the electrodes is converted to impedance. Since impedance changes with variations in blood flow, penile volumetric change is measured noninvasively. We applied this procedure to the development of a new device to evaluate erectile activity nocturnally, and we report our findings in men with no history of erectile dysfunction.
Our study group comprised 10 men with a mean age of 44 years who had no history of erectile dysfunction. The NEVA device consists of a small recording device attached to the upper thigh, and 3 small adhesive electrode pads placed over the hip and on the penile base and glans, respectively. Each subject used the NEVA device for 2 nights.
Overall 20 nights of electrobioimpedance volumetric assessment were recorded. Tumescence monitoring revealed 3 to 6 erections per night per subject (mean 3.45) lasting 10 to 50 minutes (mean 17). As determined from the impedance measurements, mean volume change was 14.4 ml. with a 213% mean volume change over baseline.
The new NEVA device is small, comfortable to wear and easy to use. It determines the number and duration of erectile events and percentage increase of blood volume changes during these events in normal men in a noninvasive manner. Future directions of study include a comparison to men with erectile dysfunction and analysis of the dynamic information of the NEVA data.
To determine the neurophysiological and vascular factors in diabetic impotence, particularly the role of autonomic neuropathy on venous leakage and erectile impotence.
Thirty-four diabetic men with impotence were investigated using various neurophysiological and radiological methods. The results were compared with those from patients with idiopathic penile venous leakage for autonomic neuropathy, especially for spontaneous cavernosal activity (SCA).
Of the neurophysiological tests, the SCA was most frequently abnormal, with the loss of normal periodic oscillations. Penile venous leakage, either alone or with arterial insufficiency, was the most frequent vascular problem (67%) in patients with diabetic impotence, in whom the SCA was absent in most (83%). Conversely, the SCA was normal in all impotent patients with idiopathic venous leakage.
Venous leakage in diabetic patients is probably produced by autonomic dysfunction of the penile vascular innervation or degeneration of penile smooth muscles, because the SCA was absent more often in these patients.
Electrobioimpedance volumetric assessment is a procedure that can measure penile length, cross-sectional area, and volume. From these variables, the number and duration of erectile events, volume change, and percentage of volume increase from baseline can be determined. This procedure was performed on patients with erectile dysfunction (ED) and findings were compared with patients with no history of ED. Examples of etiology are reported.
Two groups of patients with ED were evaluated by electrobioimpedance assessment. Group 1 patients (n = 23), ranging in age from 26 to 60 years (mean 50), were involved in simultaneous electrobioimpedance assessment and duplex Doppler ultrasound penile volume measurements. A tissue correction was derived. Group 2 patients (n = 10), ranging in age from 38 to 64 years (mean 50), used nocturnal electrobioimpedance volumetric assessment (NEVA) at home for 2 consecutive nights.
After deriving an expression to correct for tissue volume, simultaneous measurement of penile blood volume by NEVA and duplex Doppler showed that the regression line for study participants and the identity line was not significantly different by analysis of variance. Using NEVA in comparing patients with ED to a reference population with no history of ED, and using a two-tailed Student's t test for means, the data demonstrated a statistically significant (P < or =0.05) difference in the number of erectile events and percentage of volume change over baseline. With NEVA data, it was possible to distinguish arterial insufficiency from veno-occlusive dysfunction.
The present study demonstrates that electrobioimpedance volumetric assessment can be used in patients with ED. Compared with a reference population with no history of ED, the group with ED had fewer nocturnal erectile events that resulted in a smaller increase in penile blood volume change over baseline. Although the time dependence of the measured variables identifies the cause of ED, the application of NEVA to a larger population will allow further analysis of the dynamic information contained in the NEVA data.
To compare the efficacy, safety, and patient preference of intracavernously administered alprostadil alfadex and intraurethrally administered alprostadil.
A crossover, randomized, open-label multicenter study of 111 patients with erectile dysfunction of at least 6 months' duration compared the efficacy, safety, and patient preference of intracavernosal alprostadil (EDEX/Viridal) with MUSE plus optional ACTIS. All patients underwent an in-office dose titration with either drug before undertaking an at-home treatment phase. The most frequently used doses during the at-home phase were 40 microg (44.1% of men) and 1000 microg (86.8% of men) for EDEX and MUSE, respectively; the mean doses were 26.1 microg and 922.5 microg for EDEX and MUSE, respectively.
More EDEX than MUSE administrations resulted in an erection sufficient for sexual intercourse (82.5% versus 53.0%); significantly more patients using EDEX achieved at least one erection sufficient for sexual intercourse (92.6% versus 61.8%; P <0.0001); and EDEX use resulted in a significantly greater percentage of patients attaining at least 75% of erections sufficient for sexual intercourse (75% versus 36.8%; P <0.0001). Penile pain was the most common side effect for both medications: 20.0% versus 30.5% (in-office) and 33.8% versus 25.0% (at-home) for EDEX and MUSE, respectively. Similar numbers of adverse events were reported with either treatment during the at-home phase. Patient and partner satisfaction was greater with EDEX, and more patients preferred this therapy, choosing to continue it during a patient preference period at the end of the study.
Since intracavernous injection therapy was more efficacious, better tolerated, and preferred by the patients and their partners, it should be offered as the first-choice treatment if oral therapy fails or is contraindicated.
We aimed to assess objectively the integrity of the parasympathetic neural pathway that controls the inflow choke vessels to the corpora cavernosa in a group of male patients with postproctectomy erectile dysfunction.
The study group was male patients with erectile dysfunction after proctectomy for rectal cancer and inflammatory bowel disease identified by sexual function questionnaire. The group underwent two consecutive nights of home nocturnal penile tumescence monitoring with the Nocturnal Electrobioimpedance Volumetric Assessment device. The control group was also monitored. It comprised preoperative potent patients with rectal cancer and inflammatory bowel disease who had not yet undergone a variety of surgical procedures. Demographics and nocturnal penile tumescence parameters were recorded, including number, duration, and percentage increase in penile volume of tumescent events.
Thirty-four impotent study group and 28 potent control group patients underwent nocturnal penile tumescence monitoring. The groups were well matched for mean age (difference, 1.4 years; 95 percent confidence interval, -5.8 to 8.6 years) and proportion with rectal cancer (difference, 6 percent; 95 percent confidence interval, -1 to 13 percent). The number of nocturnal penile tumescent events was greater for the potent group than for the control group (mean rank, 40.4 vs. 24.2; P = 0.0004). There was no significant difference between the mean duration (difference, 2.6 minutes; mean rank, 27.9 vs. 34.4; P = 0.16) or the mean penile volume increase (difference, 5.4 percent increase; mean rank, 30.6 vs. 32.6; P = 0.66) for tumescent events between the study and control groups. Mean age was significantly higher in complete than in partial impotence (60.9 vs. 53.1 years; difference, 7.8 years; 95 percent confidence interval, 0.1 to 15.5 years). There was a nonsignificant trend to a lower mean number of tumescence events among sildenafil responders than among nonresponders (3.5 vs. 4.8 events; mean rank, 11.2 vs. 17.3; P = 0.14).
Nocturnal penile tumescence activity is diminished but not ablated by the trauma of surgical dissection. This suggests that some of the cavernous nerves that govern inflow to the corpora cavernosa are intact after surgery and that the nerve lesion responsible for erectile dysfunction is partial, and it explains why the response to sildenafil in such patients is surprisingly high.
Phosphodiesterase type-5 (PDE-5) inhibitors are a new class of vasoactive drugs that have been developed for treatment of erectile dysfunction (ED). The mechanism of action involves active inhibition of the PDE-5 enzyme and resulting increase in cyclic guanosine monophosphate (cGMP) and smooth muscle relaxation in the penis. Sildenafil citrate (Viagra) is a potent and selective PDE-5 inhibitor, which is the first drug in this class to be approved for treatment of ED. More than 10 million men worldwide have been treated with this drug. Sildenafil has been shown to be generally effective in the treatment of ED, although the degree of efficacy varies according to the etiology and severity of the disorder. The drug is well tolerated, with relatively few contraindications (e.g., nitrates) and safety risks. The cardiovascular effects of sildenafil, in particular, have been extensively investigated. The results of recent studies suggest that sildenafil may have an additional role in the treatment of other male and female sexual disorders, such as premature ejaculation and female sexual arousal disorder, although results to date are inconclusive. Two additional agents in this class (tadalafil [Cialis], vardenafil [Levitra]) have been developed recently and are under regulatory review. Tadalafil is a long-acting PDE-5 inhibitor, which is effective for up to 36 hr in the majority of men. Vardenafil has a similar duration of action to sildenafil, but is more potent and selective biochemically. Both drugs appear to be generally safe and well tolerated, with a similar side-effect profile to sildenafil. There are no controlled comparison studies to date. Despite the overall effectiveness of PDE-5 inhibitors in the treatment of ED, significant psychological and interpersonal issues need to be addressed in their clinical use. The potential impact on societal attitudes toward sexuality and sexual dysfunction also warrants consideration.
IC 351) provides prompt response and extended period of responsiveness for the treatment of men with erectile dysfunction
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