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Synthesis of the Evidence The outcomes for each study were summarized qualitatively erectile dysfunction miracle purchase 120mg sildalis visa. The information pertaining to erectile dysfunction hotline order sildalis 120 mg free shipping sample size and demographics erectile dysfunction doctor in bangalore sildalis 120 mg with mastercard, setting impotence biking buy cheap sildalis 120mg on line, funding source, treatment (dose and duration), comparator characteristics, study quality, and confounders was recorded and summarized in the text and summary tables. The decision to statistically pool results of individual studies was based on clinical and methodological judgement. The degree of statistical heterogeneity was 2 evaluated using a chi-square test and the I statistic. A series of subgroup analyses was also performed to explore the consistency of the results. This variation reflected differences in diagnostic criteria for hypogonadism, testosterone measurement methods (e. The prevalence of hypogonadism was higher in men ? 50 years versus men < 50 years of age. Results from four head-to-head trials comparing sildenafil, vardenafil, and tadalafil for improvements in erectile function were inconclusive. In all 4 trials, higher proportion of patients preferred tadalafil to sildenafil or vardenafil. The mean time (in hours) between dosing and sexual attempt was longer for tadalafil compared with sildenafil (5. In three trials, the use of intraurethral suppositories containing alprostadil was shown to be more effective than placebo. In only one of four small trials, the intramuscular injection of testosterone improved erectile function compared with placebo. Gel testosterone (50 mg and 100 mg doses) was found to have increased sexual intercourse frequency compared with placebo or patch testosterone. The use of both sildenafil and vardenafil was associated with an increased risk of headache, dyspepsia, or flushing compared with placebo. The differences in the incidence of any adverse events between treatment and placebo groups did not vary significantly among four head-to-head trials with patients treated with sildenafil, tadalafil, or vardenafil. Penile pain or priapism was more frequent in patients treated with alprostadil injections compared with those who received placebo. Patients who received a testosterone patch had a higher rate of skin reactions at the application site compared with those who received the placebo. One trial reported prostate cancer in two patients treated with a testosterone patch. The use of gel testosterone did not show a dose-related increase in adverse events. Prevalence of endocrinopathies, patient characteristics, diagnostic criteria, age distribution, laboratory methods (cut-off values, total, free, bioavailable hormonal levels), and/or study methodology varied widely. These measures are based on patient responses, and therefore are subjective in nature. Patients preferred tadalafil over sildenafil or vardenafil in four head-to-head trials in part due to the longer duration of the action of tadalafil compared with the other two agents. The evidence regarding the incidence of serious adverse events is not conclusive for several reasons, including poor reporting practices and the use of different definitions of serious adverse events. Some reports indicated only the most frequently encountered or treatment-related adverse events, the ascertainment of which may be prone to subjective judgment. In open label trials, patients or investigators may have over- or underreported the incidence of adverse events because of their knowledge of the assigned treatment. The comparative evidence for the efficacy and harms associated with subcutaneous injections, sublingual, topical treatments, or intra-urethral suppositories was limited and inconsistent. One common limitation of the trials evaluating these therapies was that clinically relevant efficacy outcomes were not reported. Viewed in perspective, this report represents a striking example of a situation that reviewers of medical effectiveness research encounter often: a field of information in which one corner is intensively cultivated and other areas lie fallow. Erectile dysfunction can be treated at present by two main classes of drugs, phosphodiesterase type-5 inhibitors and/or androgens. In light of the growing popularity of androgen supplementation for a variety of indications in aging men, and in the context of complicated and controversial findings of the far more extensive studies of hormone replacement therapy in women, this gap in our research base is especially noteworthy. The effects observed in the controlled trials mostly denote differences of small magnitude in self-reported subjective judgments of function on a standardized questionnaire (e. Because of the randomization and the large number of subjects, the evidence is convincing that there is some therapeutic effect; the extent to which these “real” effects are great enough to be clinically meaningful is not as clear, and that is a separate question which this review does not address. The value of information might be enhanced by new sources of financial support for research and/or a change in regulatory requirements that would encourage broader comparisons and a longer time horizon. Conclusions The evidence comparing cause-specific therapies with symptomatic treatments (e. There is no universal consensus or agreed criteria as to how consistent the problem (i. A period of persistence over 3 months has been suggested as a 1,2 reasonable clinical guideline. Physiology of Erection Penile erection is a complex process involving interactions between neural, psychological, vascular, and hormonal factors. The pathway of normal sexual function in males consists of four stages: sexual desire (i. Erection subsides at ejaculation or cessation of sexual stimulation and the subsequent flaccidity state is maintained until the next sexual stimulation or nocturnal erection occurs. Thus, both the erection and the flaccidity states of the penis exist in two phases, initiation and maintenance. Pathways responsible for penile Appendixes and Evidence Tables for this report are provided electronically at http://www. The initial phase of smooth muscle relaxation results in reduced peripheral resistance of cavernosal arterioles and thereby allows blood to flow in to the penis under the driving force of systemic 4 blood pressure. In addition, oxygen tension and substances secreted by endothelium lining the sinusoidal spaces, (i. The somatic sensory nerves originate at receptors in the penis to transmit pain, temperature, touch, and vibratory sensations, and the brain modulates the spinal pathways of erection via the medial preoptic area and paraventricular nucleus of the hypothalamus, periaqueductal gray of the 3 midbrain, and the nucleus paragigantocellularis of the medulla. On the other hand, norepinephrine, phenylephrine, and endothelin appear to activate phospholipase C, leading to the formation of inositol triphosphate and diacylglycerol. The net result is increased cytoplasmic calcium and subsequent smooth-muscle contraction. Activated Rho-kinase phosphorylates, inhibits the regulatory subunit of smooth muscle myosin phosphatase, preventing dephosphorylation of myofilaments and 10 maintaining contractile tone. In the flaccid state, these smooth muscles are tonically contracted due to intrinsic smooth-muscle tone, adrenergic discharge, and other signaling molecules such as 4 endothelin. Erectile dysfunction is one of many symptoms of sexual disorders including premature ejaculation, increased latency time associated with age, psycho-sexual relationship problems, and loss of libido. Recommendations based on biochemical investigation may consist of hormonal screening to detect hypogonadism or other underlying common diseases such as hyperprolactinemia, diabetes 19,20 and dyslipidemia. There are also specialized evaluation techniques such as duplex ultrasonography, penile tumescence studies, RigiScan, test injections, 21 audio-visual stimulation and penile brachial index measurement. There was a total prevalence of erectile dysfunction of 52 percent when participants with minimal (17. Both the prevalence and severity of erectile dysfunction increased proportionally with age. Analyses by the Erectile Dysfunction subgroup for the Urologic Diseases in America Project identified that almost 1. National pharmacy claims data indicated an increased prevalence of sildenafil use from 1. For example, in 2002, 6 30 percent of men aged 55 or older had one or more claims for sildenafil. According to national sales, in 2005, the pharmaceutical costs of sildenafil, tadalafil, and vardenafil were $1. According to this framework, treatment effectiveness consists of two dimensions: treatment response and treatment satisfaction. These measures are all based on patient responses and therefore 18 are subjective in nature. The other domain of treatment effectiveness—treatment satisfaction— is defined as the degree to which the effects of any particular treatment correspond or exceed the 36 expectations of a patient and his partner. In summary, according to this framework, the overall measure of treatment effectiveness should ideally integrate the information on both treatment response (i.
Toward public health nutrition strategies in the European Union to implement food based dietary guidelines and to enhance healthier lifestyles. The costs of illness attributable to physical inactivity in Australia: A preliminary study. Gottingen: Hogrefe Wellings K, Collumbien M, Slaymaker E (2006) Sexual behaviour in context: A global perspective. New York, Cambridge University Press Zuckerman M (1983) Sensation seeking and sports. There is evidence that some men use primary health services less frequently and are more likely to need hospitalisation for the principal causes of disease. There is also evidence that men do not use preventative services at the same level as women, which may be due to the availability of services only being available during the working day so inaccessible to many men. Men have higher levels of usage of the internet for health advice and are more likely to buy drugs through this route (and therefore more vulnerable through missed diagnosis and the rise of counterfeit drugs). Conversely men tend to show no difference to women with regard to presenting with symptoms of illness. Where services have been set up in ways that make access easier then men have used them and many have been shown to have high levels of hidden problems, both physical and emotional. Against a background of higher premature death rates among men for nearly the whole range of non-gender specific disease and illness, there is an urgent need for more targeted measures that enable boys and men to recognise their health risks and to take increased responsibility for managing their own health. There also needs to be an increased focus on how health services can be configured to be more successful at targeting men. That men’s lower contact rates with primary care services are offset by higher hospitalisation rates (Juel & Christensen, 2007) and when men do avail of primary care services, consultation times tend to be shorter than for women, and men tend to ask fewer questions (Courtenay, 2000). Men who are unemployed or in manual work tend to attend a doctor more often than those engaged in managerial or professional occupations (Office for National Statistics, 2004). Infrequent use of and late presentation to health services have been associated with men experiencing higher levels of potentially preventable health problems and having reduced treatment options (Banks, 2001; Fletcher at al. This is of particular concern in the context of men’s higher risk of developing and prematurely dying from a range of health conditions (White & Holmes, 2006). Increasing men’s use of primary care services is particularly important, since primary care is usually the gateway to accessing other healthcare services, and is a crucial link in the continuum of effective health service utilisation. In order to promote increased and more prompt usage of health services by men, it is important to identify potential limitations within existing services in not meeting men’s needs, and possible barriers within men themselves that may lead to a delay in seeking help. It is also important to identify where such barriers exist for men, in terms of the chain of events leading from perception of need through to attendance at primary care (Adamson at al. Consideration should also be given to the variability within and between men and in different help-seeking situations (Addis & Mahalik, 2003). The main differences in the provision of primary care between countries in Europe concern the presence or absence of registration with a general practitioner and the gate-keeper role of primary care (Thomas, 2005). When both of these features are present, health outcomes, in terms of morbidity and mortality tend to better (ibid). This accessibility gap between the highest and the lowest income quartiles is particularly pronounced in the new Member States (Alber & Kohler, 2004). There is also an accessibility gap between unemployed and retired people compared to those who are employed, with such disparities also being considerably higher in new Member States (ibid). There has been an increased focus on the issue of informal payments with regard to equity of access to health services. Despite universal coverage of the population by public health insurance, the authors report that informal payments are common and are a major source of inequity and inefficiency in the Greek health care system. Unofficial payments are particularly prevalent in the transition countries of Central and Eastern Europe (Gaal & McKee, 2005; Ensor, 2004). In Bulgaria, Balabanova and McKee (2002) demonstrate that the longstanding principle of comprehensive free coverage has been significantly eroded by ‘informal payments’, especially in the form of gifts. Such payments have stemmed from the low income of staff, patients seeking better treatment and acute funding shortages within the healthcare system. Men are less likely than women to report a long-standing illness or health problem (26% v 31%) or to be undergoing a medical long-term treatment (22% v 28%) (Eurobarometer, 2007 – Fig. Hypertension (35% for men, 152 37% for women) and muscle, bone and joint problems (17% for men, 28% for women) are cited as the most common reasons for medical long-term treatment. Hypertension is more of a problem in East-Central Europe and the Mediterranean, whilst muscle, bone and joint problems are more prevalent in East-Central Europe. Source: Eurobarometer 2007 Not surprisingly, the same report (Eurobarometer, 2007) found that men were less likely than women to report long-term disruption of activities due to health problems (26% v 31%); to report pain in the past week that affected their daily living (27% v 37%), or to report chronic restrictive pain (22% v 28%). Diseases of the circulatory system (16%), injuries, poisoning and external causes (11%) digestive system (10. There are some notable male/female differences in admission rates within countries. For example, the age standardised admission rates for neoplasms are considerably higher in Hungary for men than for women (26/21), whilst a reversal of this pattern is seen in Latvia (15/20). Mental and behavioural disorders are notably higher for men than for women in both Latvia (18/10) and Lithuania (14/8). These same countries have the highest rate of admissions and the largest male/female differences in rate of admissions for respiratory diseases (34/24 for Lithuania and 32/25 for Latvia) Fig 1. Whilst admission rates for injuries poisoning and external causes are higher for males than for females across all countries, the gap is particularly pronounced in Austria, Latvia and Lithuania (Fig. It should be noted, however, that this may be an artefact of the health systems in these countries and should be treated with caution. Even those cases that are treated by day hospitalisations are reported as a full admission. Bulgaria, Belgium), male day patient hospitalisations are higher among those with lower levels of education, whilst this pattern is reversed in other countries (e. Whilst the initiative for the majority of dental check-ups and eye tests comes from men themselves, the majority of hearing tests undertaken by men are at the prompting of a doctor or as part of a screening initiative. For example, the overall uptake of dental check-ups ranged from 81% in Luxemburg to 36% in Spain and Romania. Men are more likely to have had a heart check-up (29% vs 26% of women), but less likely to avail themselves of x-ray or other scans (34% vs 41% of women). Whilst colorectal cancer testing is similar between men and women at 8%, men are far less likely to undertake other tests for cancer (6% vs 16% of women). Overall, the testing rates for blood pressure range 162 from 70% or above in Luxembourg, Estonia and Portugal to 46% in Ireland, with just over half of blood pressure checks being carried out upon doctors’ initiatives. Among those with hypertension, similar proportions of men (48%) and women (50%) had recently made lifestyle adjustments with the aim of reducing their blood pressure. The overall rates of reported cholesterol testing were highest in Luxembourg (57%), Portugal (56%) and Greece (55%) and lowest in Romania (21%) and Bulgaria (23%). The main initiative for cholesterol testing comes from doctors (20%) followed by patients themselves (13%) and screening programmes (5%). Some 13% of respondents reported 22 having changed their lifestyle in order to lower their blood cholesterol. Whilst this differential can partially be explained by reproductive health and antenatal visits in the peak years of female fertility between 15 and 44, after this the rate of visits for preventive healthcare remains much higher for women than for men (54. For example, knowledge of cancer warning signs is poorer among men than among women (Wardle at al. In the context of delayed help-seeking for chest pain, White and Johnson (2000 p540) stress the importance of addressing the ‘knowledge deficit’ that men have in relation to their own bodies, and their apparent inability to recognize pain as being potentially of cardiac origin. There have been few evaluations conducted around the effectiveness of existing health information targeted at men. These included; • a lack of uniformity in the form and content of information given 164 • that certain topics, which were perceived as relevant to the patient, were omitted • that the terminology used was not clear • that patients’ experiences were at odds with what they were told by their surgeons. For example, only 5 of the 25 different fact sheets being used referred to possible changes in sexual sensation after transurethral resection of the prostate, stating that patients would feel no change. However, 35% of patients did in fact report a change, and this was a cause of concern or worry to 12% of patients. The authors concluded that there is much scope for improving the standard of printed information given to patients undergoing prostatectomy.
J Sex Educ Ther 1998; directed masturbation: a comparative study on female 23:229-231 drugs for erectile dysfunction pills buy cheap sildalis 120mg. The effectiveness of psy- behavior sex therapy for psychogenic erectile dysfunction: a chological interventions for the treatment of erectile pilot study erectile dysfunction medication otc sildalis 120 mg overnight delivery. J Person and Soc vs sildena?l plus brief couple sex therapy on erectile Psychol 2014;106:843-866 erectile dysfunction juice recipe sildalis 120mg amex. Increased risks of for erectile dysfunction: a narrative review and meta-analysis erectile dysfunction drugs herbal purchase sildalis 120 mg on-line. Role of attribution and intra-penile injections in the treatment of erectile dys- in affective responses to a partnered sexual situation among functions: rationale and predictors of outcome. Arch Sex marital satisfaction and psychological counselling on the Behav 2011;40:395-406. Non-erotic thoughts and sexual func- improved erectile rehabilitation after nonenerve-sparing tioning. J Sex Marital Ther 2015; vacuum devices augmenting psychosexual therapy for 41:680-690. A longitudinal study of anxiety, depression and distress as predictors of sexual and 344. Clinical study on treatment of premature urinary quality of life in men with prostate cancer. Long-term psychological improves when partners are administered vardena?l for and sexual outcomes of severe penile hypospadias repair. J erectile dysfunction; A prospective randomized, double-blind, Sex Med 2011;8:1529-1539. The South life after hormonal and surgical treatment, including phallo- Australian couples sildena?l study: double-blind, parallel- plasty, in men with micropenis: a review. J Sex Med 2013; group randomized controlled study to examine the psycho- 10:2890-2903. J Sex Med on children’s maltreatment of gender-nonconforming peers: 2008;5:1198-1207. After the model was built, were not statistically signi?cant, there was a trend towards higher immuno?uorescence with the recognized marker of pericytes and erectile function in patients using the Viberect device. We review the re- found the pericytes through immuno?uores cence, electron mi- sults of this treatment that was administered at our centre. For example, pericytes are located neaby the an established protocol by the American academy of cosmetic endothelial cells of the cavernous sinus for supplying blood for and cellular medicine (Priapus Shot). There were no reported side effects or any deterioration in 322 erectile function. Dr Kumaran Ramakrishnan, Honorary Fellow, Rehabilitation Studies Unit, Sydney Medical School Northern, The University of Sydney, and Consultant Rehabilitation Physician & Senior Lecturer, Department of Rehabilitation Medicine, University Malaya. Dr Ian Cameron, Head of the Rehabilitation Studies Unit, Sydney Medical School Northern, The University of Sydney. It may be reproduced in whole or part for study or training purposes subject to the inclusion of an acknowledgment of the source. Reproduction for purposes other than those indicated above, requires written permission from the Agency for Clinical Innovation. We wish to acknowledge Dr Stella Engel, Dr Sue Rutkowski, Dr Bon San Bonne Lee, Dr Douglas Brown, Prof Anne Tonkin, Dr Mary-Clare Waugh and Dr Komal Adarkar for their contribution to the original and/or subsequent factsheet/s. Individual therapeutic decisions must be based on clinical judgment with a detailed knowledge of the individual patient’s unique risks and medical history, in conjunction with this resource. Following stimulation, overactivity of sympathetic ganglia remains uncontrolled due to isolation of the spinal cord below the injury from normal regulation by vasomotor centres in the brainstem (refer to Figure 1). Flushing due to dilatation of blood vessels, which is probably also responsible for headache, and profuse sweating above the level of injury also occur (via sympathetic inhibitory outfow from vasomotor centres). However, both of these mechanisms are insuffcient to satisfactorily control paroxysmal hypertension due to massive sympathetically- mediated vasoconstriction of the splanchnic bed. Impulses travelling intercourse, labour or severe menstrual through the vagus nerve cause secondary cramping. Typically, the patient will complain of a pounding • bradycardia headache with fushing and profuse sweating above the level of spinal lesion, with or without other symptoms such • fushing/blotching of skin above spinal injury level as nasal congestion (stuffness), blurred vision, shortness of • profuse sweating above spinal injury level breath and/or anxiety. Skin pallor and piloerection (goose • skin pallor and piloerection below spinal bumps) can be seen below the level of spinal lesion. Women with spinal cord injury above the mid thoracic region (T6 level) who are pregnant may experience autonomic dysrefexia as the frst sign of the commencement of labour. To help determine if bladder is empty or not, consider patient’s fuid intake and • Ask patient and carer if they suspect a cause. This is certainly true when performing the If bladder is distended and patient is unable to void in procedure of manual evacuation and autonomic dysrefexia their usual manner, lubricate the urethra with a generous will be exacerbated during prolonged nociceptive (6) amount of lignocaine 2% gel, wait 2 to 3 minutes and stimulus to remove faecal matter. Drain urine which medication is given prior to more straightforward and be alert for sudden hypotension due to rapid procedures, such as catheterisation, may vary (e. Dosage may be titrated by removing the If you are sure the bladder is empty and symptoms persist, transdermal patch or by spitting out residual spray or apply a generous amount of lignocaine gel on to the anal tablet with hypotensive effect being shorter lasting. Where control of the noxious stimulus is diffcult, regional epidural anaesthesia may be appropriate. An acute episode of autonomic dysrefexia can lead to an increased susceptibility to further episodes due to excess circulating catecholamines. These may be precipitated by activities which would not normally do so, such as performing muscle stretches, bowel care, or other activities. The patient must be alerted to this possibility and monitored appropriately for 48 to 72 hours. Perform thorough survey of the patient to • Episode of autonomic dysrefexia will not resolve until determine cause of autonomic dysrefexia. Beginning with urinary system: • The urinary tract, particularly bladder distension, is the If catheter is in situ: commonest cause of autonomic dysrefexia. Large volume of fuid • If catheter appears to be blocked attempt to instilled in bladder may further exacerbate autonomic unblock catheter by pulling back on the syringe. If block persists, gently irrigate catheter with 10 to 15 mls of normal saline at body temperature. Lignocaine gel may decrease sensory input lignocaine gel (if readily available) in to the urethra and relax sphincter for catheterisation. Commence systematic survey of patient for Autonomic dysrefexia will not resolve without fnding and other causes of autonomic dysrefexia, which remediating the underlying cause. If no cause can be found and symptoms persist obtain assistance from Spinal Unit Consultant. Episode is considered to be resolved when: • Cause of autonomic dysrefexia has been identifed. Table continues on page 11 10 Treatment of Autonomic Dysrefexia for Adults & Adolescents with Spinal Cord Injuries Table continued from page 10 Action/Intervention Rationale - Educate patient, carers, signifcant others. Additional education may be required to help recognition of symptoms, treatment and strategies to avoid further episodes as much as possible. It is important to also alert the patient and carers to the possibility of increased susceptibility to further episodes over following few days. A Cardiovascular consequences of loss of supraspinal systematic review of the management of Autonomic control of the sympathetic nervous system after spinal Dysrefexia after spinal cord injury. Diffuse Idiopathic Skeletal Hyperostosis Scheuermann’s Disease Paget’s Disease § Affects an estimated 3 percent of people over the age of 40. Cauda equina n Most common cause is central disc prolapse which occupies all or most of the spinal canal compressing lumbar and sacral nerves at that level and lower levels of the spinal column. Compression of the nerves leads to a potential loss of sphincter tone, incomplete emptying of the bladder and compromise of the stretch receptors and/ or difficulty initiating micturition or defecation. Cauda equina symptoms n Back pain with nerve root distribution of pain (one or more nerve roots involved) n Sciatica n Saddle parathaesia and/ or anesthesia around the anus, perineum or genitals n Faecal incontinence n Bladder dysfunction= e. Described as being squeezed Malignant spinal cord compression n Pain usually located in the back but radicular pain can be caused by valsalvas manoeuvre eg straining, coughing n Pain described as shooting, sharp, deep n Pain may be aggravated by lying down, bone pain sometimes less if lying prone n Night pain n Pain may be eased by sitting n Nerve pain in upper thighs Subjective n Highest prevalence 40-65 years n (89% patients over 50 n Men less likely to consult for medical advice and therefore often present late n Patients with cancer who describe severe back or spinal root pain require urgent assessment n Altered sensations in legs n Heaviness in the legs often associated with muscle weakness or legs may feel odd or strange Objective n Neurological deficit often occurs late in disease process n Muscle weakness can begin in lower limbs regardless of level of cord compression n Difficulty in mobility such as climbing stairs, reported falls, difficulty walking. Use a generous amount of ultrasound gel, and hold the penis firmly against the applicator. Protocol recommendations have not been tested in sham-controlled trials, and are subject to change as more information becomes available. For larger plaque > 15mm the urethra diameter, move the applicator to treat the whole plaque Peyronie’s plaque Avoid the dorsal vasculature and urethra Confidential and Proprietary 18. Bone marrow hypocellular Mildly hypocellular or <=25% Moderately hypocellular or Severely hypocellular or >50 - Aplastic persistent for longer Death reduction from normal >25 - <50% reduction from <=75% reduction cellularity than 2 weeks cellularity for age normal cellularity for age from normal for age Definition: A disorder characterized by the inability of the bone marrow to produce hematopoietic elements.
The authors of this trial did not report the proportion of patients in each arm that withdrew due to adverse events. Quantitative Synthesis - Meta-analysis of Trials 248-250,252,253 Apomorphine mono versus placebo. Trials (all crossover design) comparing the efficacy and safety profiles of apomorphine and sildenafil were not meta-analyzed because of clinical 71 114,117,120,148,159 heterogeneity with respect to populations and outcomes. For example, in two trials 114 120 the patient populations were nonarteriogenic and arteriogenic. Overview of Trials Among the 42 unique trials, 32 used a crossover design (n = 1957; range: 7 to 240 subjects) and 10 a parallel design (n = 1074, range: 30 to 296 subjects). Three trials exclusively enrolled men with previous radical prostatectomy or cystectomy (n = 159 subjects). Only eight trials reported smoking status, two trials ethnicity, and none reported body weight (e. One specific alprostadil combination (alprostadil plus papaverine plus phentolamine) was also tested alone or in combination with other pharmacologic agents. For a full description of treatment interventions in these individual trials refer to Evidence Table F-5 (Appendix F). Study Quality and Reporting Information on pharmaceutical funding was provided for nine trials. Only three studies specifically reported the use of an intention-to-treat analysis. Study withdrawals, drop-outs or lost to followup were reported in 33 trials and were 13 percent (16 percent in crossover studies and 6 percent for parallel studies). The majority of the trials were considered to be of low quality with total Jadad score < 3. Only six of the 43 trials received a score of four, and none received a score of five. Of the clinically relevant outcomes, more commonly reported were quality of erections achieved at home, without regard to whether the patient was able to achieve successful sexual intercourse, (e. In placebo-treated subjects, none of the participants had priapism in the first trial, and no priapism- related data were reported for the second trial. In two of these trials, placebo-treated 266,268 participants did not experience improved erections the other two trials did not report any 281,292 outcomes data for the placebo groups. The third trial reported more frequent occurrence of pain in the papaverine participants (32. Approximately 8 percent of the participants in each treatment group reported prolonged erection. One trial compared the efficacy and harms associated with 293 the use of papaverine versus moxisylate. In total, 10 percent of the papaverine-treated participants reported improved erections versus 7 percent of the moxisylate-treated participants (p ? 0. One trial compared the efficacy and harms for a single 30 mg dose of papaverine followed by a single 50 172 mg dose of sildenafil versus a single 50 mg sildenafil dose followed by 30 mg papaverine. Adverse events were reported for both treatment groups combined, including priapism (10 percent), headache (4 percent), blurred vision (2 percent), and dyspepsia (2 percent). Though no participants receiving placebo experienced any of these side effects, these differences were not statistically significant. The corresponding proportions reported for the other study were 60 versus 30 percent, 267 respectively. One trial compared the efficacy and harms 266 of papaverine plus phentolamine versus placebo. Papaverine plus phentolamine versus papaverine plus phentolamine plus sexual counseling. One trial compared the efficacy and harms of papaverine plus phentolamine versus 257 papaverine plus phentolamine plus sexual counseling. The mean values on a self-rated erections score (scale 0–100) for papaverine plus phentolamine versus papaverine plus phentolamine plus sexual counseling groups were 79 versus 84 percent, respectively. About half (50 percent) of the participants randomized to trimix reported grade 4 or 272 5 erections versus 21. One trial compared the efficacy and harms of trimix 264 versus trimix plus atropine. Addition of atropine to trimix did not reduce pain or improve erections compared with trimix alone. One trial compared the efficacy and harms 283 of trimix injections with and without sodium bicarbonate. The difference between the rates of improved erection in participants allocated to trimix plus sodium bicarbonate versus trimix alone was not statistically significant (78. There was no statistically significant difference between the treatment groups with respect to pain during injection (4. Based on the phentolamine dose to which responses were observed, 240 participants were randomized in a crossover design to active treatment versus placebo. Efficacy results were reported only for the 172 men who received at least one dose of active drug and placebo. Obesity, hypertension, and hypercholesterolemia were the most commonly reported underlying diseases. Study Quality and Reporting None of the studies reported the source of pharmaceutical funding. Study withdrawals, drop-outs or participants lost to followup were reported in all trials. Subjects were monitored by RigiScan in the clinic and at home for a total of 6 hours. The number of subjects with improved erections following administration of placebo was not reported. Patients were kept under observation until 24 hours after the dose administration. A greater than two-fold increase in the duration of base rigidity ? 60 percent, compared with placebo, was reported in 82 percent of subjects receiving the 4 mg dose and 84 percent of patients receiving the 6 mg dose. Two participants experienced extreme nausea and hypotension, with one transiently losing consciousness after the 1. Eleven out of the 12 subjects exceeded a change of 1cm in circumference after injection). Quantitative Synthesis No meta-analysis was performed due to the clinical heterogeneity with regard to intervention types. Overview of Trials 299-305 Of the seven trials, one reported only physiologic outcomes (timing and degree of 305 penile rigidity as measured by RigiScan) and no harms data. Of five studies, four assessed clinically relevant 299,300,302,304 efficacy outcome such as home sexual intercourse success and one trial reported on 299-304 whether in-clinic erections were judged sufficient for intercourse. Of these six trials, two were cross-over design (n=345; range: 111-234 participants) and four were parallel design (n=1726, range: 60-996 participants). Vascular disease and diabetes were the most commonly reported underlying diseases. Three trials utilized fixed doses of alprostadil from 125 to 1000µg administered at 300,302,304 home based on each subject’s response to various doses or a dose titration. The home 302,304 treatment phases of these trials were 3 weeks and 3 months, respectively. In another trial, subjects received single in-clinic administrations of two of four alprostadil doses (125, 250, 500 303 and 1000µg) over a 2 to 4 week period. In a sixth trial, subjects started at either 250 or 500µg alprostadil for 4 weeks with subsequent dose titration so that final dose at 12 weeks ranged from 299 299,300 125 to 1000µg. In one trial that evaluated a prazosin intervention, subjects received single in-clinic administrations of two of four prazosin doses (250, 500, 1000 and 2000µg) over 2 - 4 week 303 period. Study Quality and Reporting 299,300,302 Information on pharmaceutical funding was reported to have been provided for five 304 301 of the six trials. Participant withdrawals, drop-outs or lost to followup were reported in all trials and ranged from 7 percent to 42 percent. The majority of the trials were considered to be of low quality as assessed by the Jadad scale.
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