Minimally invasive therapies in the treatment of erectile dysfunction in anticoagulated cases: a study of satisfaction and safety

PURPOSE: We evaluated patient satisfaction with and the safety of vacuum therapy and self-injection during warfarin treatment of impotent men. MATERIALS AND METHODS: In a 24-week prospective study 33 patients were assigned to vacuum therapy or intracavernous injections with crossover at 12 weeks. Patients maintained diaries, and were followed with physical examinations, coagulation studies and questionnaires. RESULTS: Of the 33 patients 26 completed the study with 706 vacuum applications (mean 1.9 weekly) and 605 injections (mean 1.6 weekly). There are 11 acute minor complications with vacuum therapy (petechiae that resolved spontaneously) and no chronic complications. Only quality of climax was diminished with vacuum therapy. Self-injection resulted in acute minor complications (3 ecchymoses and 1 prolonged erection requiring intervention) and 1 chronic complication (corporeal fibrosis with mild curvature). CONCLUSIONS: The adverse effects of vacuum therapy and intracavernous self-injection in patients on warfarin do not exceed the rate in the general urological population. These therapies appear to be safe in patients receiving warfarin.     

Yohimbine for erectile dysfunction: a systematic review and meta-analysis of randomized clinical trials

Well-founded pharmacokinetic information is one of the cornerstones of a New Drug Application (NDA) to the Food and Drug Administration (FDA) required to introduce a new drug or a generic equivalent (ANDA) to the marketplace. The service that laboratories engaged in therapeutic drug monitoring provide to support clinical activities is also needed by the pharmaceutical industry during the evaluation and introduction of drugs to the marketplace. In considering this alternative service activity, one must be aware of and compliant with rules established by the FDA for performance of such studies. As specified in CFR 21, Parts 58, 211, and 320, good clinical and laboratory practice indicates that the laboratory should employ a Lab Study Director, who is responsible for the validation of all procedures implemented to support a study protocol, ensures that the laboratory carries out the study following these defined procedures, and personally reviews the results of all testing. The laboratory must validate each procedure by demonstrating and documenting that the procedure does what it is designed to do while meeting the analytical performance specifications required by the study. Laboratory records of all activities must be maintained and available for inspection by the FDA on request. The FDA has authority over all activities related to NDA and ANDA submissions and can bring criminal charges if results of a study are changed because a laboratory deviates from standard procedure. Competent drug monitoring laboratories are fully capable of participating in clinical trials testing activities. Laboratory staff should be fully versed in the FDA rules governing these activities, validate all procedures, and establish systems to verify the procedures are carried out as specified.     

Usefulness of tomography in the evaluation of patients with temporomandibular disorders: a retrospective clinical study

OBJECTIVES: To evaluate the effect of temporomandibular joint tomography on the diagnosis and management of temporomandibular disorders and to determine whether there were any clinical predictors of usefulness of tomography in providing new information helpful in the treatment of these patients. STUDY DESIGN: The charts of 116 patients with temporomandibular joint tomograms were reviewed retrospectively for presenting signs and symptoms, initial clinical diagnosis, and alterations in diagnosis and management as a result of tomography. RESULTS: Common clinical diagnoses included osteoarthrosis (54%) and internal derangement (42%). Tomography changed the diagnosis in 24%, mainly adding or subtracting osteoarthrosis, and altered the management in 17%. Most of the latter were minor changes in treatment recommendations. There were few clinical variables that were related to whether tomography changed diagnosis or management. CONCLUSIONS: Tomography seems to have a minimal effect on the diagnosis or management of temporomandibular disorders based on the results of this retrospective study.     

Efficacy and safety of transurethral alprostadil in patients with erectile dysfunction following radical prostatectomy

PURPOSE: A retrospective analysis of the MUSE clinical trial was performed to evaluate the efficacy and safety of transurethral alprostadil in patients with erectile dysfunction after radical prostatectomy. MATERIALS AND METHODS: Patients received doses of transurethral alprostadil in the clinic and those for whom a suitable dose was determined were treated at home with active drug or placebo for 3 months. Patients had undergone radical prostatectomy no less than 3 months before study entry. RESULTS: Of the 384 patients in whom radical prostatectomy was identified as a cause of erectile dysfunction 70.3% had an erection believed sufficient for intercourse in the clinic and 57.1% on active medication had sexual intercourse at least once at home. The product of clinic and home success rates (70.3 x 57.1%) was an overall success rate (the likelihood of active treatment to lead to intercourse at home) of 40.1%. The frequency of most adverse effects of radical prostatectomy was comparable to that of other organic etiologies of erectile dysfunction (1,127 patients). The percentage of patients with hypotension in the clinic was lower after radical prostatectomy compared to other erectile dysfunction etiologies (0.8 versus 4.2%, p < 0.001) but the percentage of patients with urethral pain/burning was higher (18.3 versus 10.4%, p = 0.027). No urinary tract infection, fibrosis or priapism occurred in the post-radical prostatectomy patients. CONCLUSIONS: Transurethral alprostadil is a well tolerated and efficacious method of treating erectile dysfunction after radical prostatectomy, although psychological changes associated with cancer and surgery may limit home response. The severe neurovascular deficit associated with prostatectomy neither limits the efficacy of transurethral alprostadil nor increases the risks.     

Oral medications in the management of erectile dysfunction

The diagnostic impact and reproducibility of the different methods used within the concept of functional MR-Mammography (FMRM) was assessed by a multi-reader-analysis. By four experienced readers, 100 histologically confirmed cases were evaluated in six different sessions. Per session, one of the following components was analyzed: clinical history (I), static MRM (II), color-coded projection images (III), time-signal curves of contrast enhancement within a large ROI (IV) and the strongest enhancing pixel (V) obtained from the histologically confirmed lesion and the complete FMRM reading (VI). The functional methods (IV-VI) revealed significantly (p < 0.05) higher specificities than the others (I-III). The highest reproducibility between the readers was observed for (IV) phi chi = 0.80, (V) phi chi = 0.76 and FMRM (VI) phi chi = 0.63. These three methods also presented the best ROC-curves and showed the highest complementarity with respect to the false positive classifications in x-ray mammography. FMRM is a reader independent, reproducible method. The analysis of the contrast enhancement time-intensity curves with high temporal resolution allows an improved differentiation of malignant and benign findings.     

Comparative study between corpus cavernosum-electromyography findings and electron microscopy of cavernosal muscle biopsies in erectile dysfunction patients

BACKGROUND/AIMS: The colonic response to obstruction is poorly understood. Thickening of the proximal bowel following colonic stricture may be due to increased protein synthesis. We have investigated the colonic morphology and collagen concentration during the development of left-sided colonic obstruction in an animal model. METHODS: Twelve male Wistar rats received either a silk ligature obstruction of the colon 2.5 cm above the peritoneal reflection (n = 6) or manipulation of the left colon (controls, n = 6). Twenty-four hours later, three colonic specimens from the ligature zone and from 1 cm proximal and distal to this site, or from equivalent regions in controls, were assayed for hydroxyproline concentration. RESULTS: In controls there was no difference in hydroxyproline concentration between colonic sites. In obstructed rats, the hydroxyproline concentration was greater both at the ligature and distally, when compared with the proximal region. The hydroxyproline concentration was higher (p < 0.05) than corresponding control values at the ligature site (14.95 +/- 2.76 vs. 10.97 +/- 1.95 microgram/mg of dry tissue mean +/- s.d.) but not on either side. CONCLUSION: The colonic collagen concentration is equivalent or raised near an obstruction, demonstrating that obstructed colon may possess an enhanced capacity to hold sutures.     

Salivary duct carcinoma: a clinicopathologic study of three cases with a review of the literature

Three cases of salivary duct carcinoma are presented. They occurred in a 60 year old man, a 66 year old man and a 57 year old woman. All of the lesions were located in the parotid gland. The tumor size ranged from 3 to 5 cm across the largest diameter. Facial paralysis was observed in two cases. Histologically, intraductal and invasive adenocarcinoma showing papillary, cribriform, and solid patterns with comedolike necrosis was observed. Immunohistochemically, the tumor cells were positive for keratin and epithelial membrane antigen. No myoepithelial cells were demonstrated within the tumor by staining for S-100 protein, alpha-smooth muscle actin or muscle specific actin. Ultrastructurally, intracytoplasmic lumina with microvilli, a moderate number of mitochrondria, lysosomes, and tight junctions were found. Regional lymph node metastasis was observed in one case, and distant metastasis developed in two cases. All of the patients were treated with adjuvant postoperative irradiation. One patient died of disease at 11 months after the initial diagnosis, another was alive with disease at 8 months, and the third patient was alive without disease at 2 years and 3 months. Salivary duct carcinoma should be differentiated from low-grade salivary gland carcinomas using morphologic and clinical criteria because of its poor prognosis even with aggressive therapy.     

Uveal melanomas in black patients: a case series and comparative review

Uveal melanomas are rare in black patients. Of a total of 2586 patients with the diagnosis of posterior uveal melanoma who were managed in the Oncology Service at Wills Eye Hospital from 1974 to 1987, 10 patients (0.39%) were black. Data on patient age (mean: 53.9 years), sex (male-to-female ratio: 7:3), and relative frequency of disease between black (0.39% of total cases) and white patients were similar to that of previous reports. The distinguishing characteristics (incidence, risk factors, complications, and prognostic indicators) of uveal melanoma in black versus white patients also were reviewed.     

Increased incidence of depressive symptoms in men with erectile dysfunction

OBJECTIVES: To investigate the hypothesis that men with erectile dysfunction (ED) have a higher incidence of depressive symptoms compared with age-matched control subjects. We also hypothesized that depressive symptoms impact on the level of libido and on the success of treatment of ED. METHODS: One hundred twenty men with ED or benign prostatic hyperplasia (BPH) were divided into three groups. Group 1 had ED only, group 2 had BPH only, and group 3 had both ED and BPH. Patients were screened for depressive symptoms using the Primary Care Evaluation of Mental Disorders and the Beck Depression Inventory. They were also surveyed for comorbidity, marital status, severity of ED, level of libido, prior ED treatment choice (if any), success of treatment, and others. RESULTS: One hundred patients completed the questionnaires. Depressive symptoms were reported by 26 (54%) of 48 men with ED alone, 10 (56%) of 18 men with ED and BPH, and 7 (21 %) of 34 men with BPH alone. Patients with ED were 2.6 times more likely to report depressive symptoms than men with BPH alone (P < 0.005). Patients with depressive symptoms reported lower libido than other patients (P < 0.0001). Severity of comorbidities did not differ among the three groups. A total of 33 patients with ED had prior treatment for ED using penile injections or vacuum devices. All 15 (100%) patients with ED only continued treatment and were satisfied with its outcome, whereas only 7 (38.9%) of 18 patients with ED and depressive symptoms continued treatment (P < 0.00021). CONCLUSIONS: ED is associated with high incidence of depressive symptoms, regardless of age, marital status, or comorbidities. Patients with ED have a decreased libido compared with control subjects. In addition, patients with depressive symptoms have a lower libido than patients without depressive symptoms. Patients with ED and depressive symptoms are more likely to discontinue treatment for ED than other patients with ED. These data emphasize the importance of a multidisciplinary approach to the treatment of erectile dysfunction.     

Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study

PURPOSE: We evaluated the erectogenic properties of a new cyclic alpha-melanocyte-stimulating hormone analogue, Melanotan-II, to treat men with psychogenic erectile dysfunction. MATERIALS AND METHODS: Ten men with erectile dysfunction of no known organic cause were entered in a double-blind, placebo controlled crossover study in which the erectogenic properties of Melanotan-II and a vehicle placebo were compared using real-time RigiScan monitoring. The presence, duration and rigidity of erections were recorded during a 6-hour period. RESULTS: In 8 of 10 men treated with Melanotan-II clinically apparent erections developed. Mean duration of tip rigidity greater than 80% was 38.0 minutes with Melanotan-II and 3.0 with placebo (p=0.0045). Transient side effects of nausea, stretching and yawning, and decreased appetite were reported more frequently after injections of Melanotan-II than placebo but none required treatment. CONCLUSIONS: Melanotan-II is a potent initiator of erections in men with psychogenic erectile dysfunction and has manageable side effects at a dose of 0.025 mg./kg.     

Clinical guidelines panel on erectile dysfunction: summary report on the treatment of organic erectile dysfunction. The American Urological Association

PURPOSE: The American Urological Association convened the Clinical Guidelines Panel on Erectile Dysfunction to analyze the literature regarding available methods for treating organic erectile dysfunction and to make practice recommendations based on the treatment outcomes data. MATERIALS AND METHODS: The panel searched the MEDLINE data base for all articles from 1979 through 1994 on treatment of organic erectile dysfunction and meta-analyzed outcomes data for oral drug therapy (yohimbine), vacuum constriction devices, vasoactive drug injection therapy, penile prosthesis implantation and venous and arterial surgery. RESULTS: Estimated probabilities of desirable outcomes are relatively high for vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis therapy. However, patients must be aware of potential complications. The outcomes data for yohimbine clearly indicate a therapy with marginal efficacy. For venous and arterial surgery, based on reported outcomes, chances of success do not appear high enough to justify routine use of such surgery. CONCLUSIONS: For the standard patient, defined as a man with acquired organic erectile dysfunction and no evidence of hypogonadism or hyperprolactinemia, the panel recommends 3 treatment alternatives: vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis implantation. Based on the data to date, yohimbine does not appear to be effective for organic erectile dysfunction and, thus, it should not be recommended as treatment for the standard patient. Venous surgery and arterial surgery in men with arteriolosclerotic disease are considered investigational and should be performed only in a research setting with long-term followup available.     

Routine psychophysiological screening of 384 men with erectile dysfunction

BACKGROUND AND OBJECTIVE: To determine the efficacy of combined phacoemulsification--trabeculectomy in preventing early postoperative increases in intraocular pressure (IOP). PATIENTS AND METHODS: Eighty patients were enrolled in a prospective cohort study. Thirty-six patients with cataracts and uncontrolled glaucoma underwent combined phacoemulsification--trabeculectomy, and 44 patients with cataracts underwent phacoemulsification alone. The operations were performed in a standardized manner by one surgeon. IOP was measured at 4 hours, 1 day, and 7 days after surgery. The need for intervention (digital massage, medications) and the presence of complications were documented. RESULTS: Four hours after surgery, 5.5% of patients undergoing the combined procedure had IOPs greater than 30 mm Hg, compared with 22.7% of phacoemulsification patients (P < .05). No significant difference in IOP was found between the groups at postoperative day 1 or day 7. CONCLUSION: These results suggest that combined phacoemulsification-trabeculectomy protects against early postoperative elevations in IOP. This finding may influence the surgical management of cataracts in patients with poorly controlled glaucoma and significant compromise of visual field or optic nerve.     

Diagnostic items and treatment of Plummer''s disease: a study on 180 patients

OBJECTIVE: To evaluate the impact of operator caseload on the sampling efficiency for early and standard, midtrimester amniocentesis. STUDY DESIGN: Prospective ascertainment of genetic amniocenteses performed during 36 months, grouped into early (13-14 weeks' gestation) and standard procedures (15-20 weeks' gestation). Details of each amniocentesis were recorded immediately after sampling, and pregnancy outcomes were retrieved via questionnaires completed by the delivering physician. Sampling efficiency was evaluated separately in the early and standard cohorts in relation to operator caseload. RESULTS: In total, 193 and 707 patients underwent early and standard amniocentesis, respectively. Forty of 46 physician-operators performed < 50 total procedures during the study interval (group A). When compared to operators performing > or = 50 cases (group B, n = 6), a higher rate of single-pass success was noted among group B physicians for both early and standard procedures (A vs. B, early: 40/45 vs. 145/148, P = .018; standard: 243/295 vs. 384/412, P < .0001). Logistic regression confirmed an independent effect of physician caseload on sampling efficiency and a significant interaction between physician caseload and simultaneous ultrasound guidance in predicting single-attempt success. CONCLUSION: Operator caseload directly influenced sampling efficiency for both early and standard, midtrimester amniocentesis.     

Subclinical trauma to perineum: a possible etiology of erectile dysfunction in young men

A substantial number of young men with erectile dysfunction have neither systemic disease nor a trauma in their history. We are familiar with impotence after major trauma but it is an unanswered question whether subclinical trauma may also induce arterial degeneration with subsequent erectile dysfunction. In a period of 36 months 129 patients underwent penile arteriography. After excluding those with major surgery, trauma or psychogenic impotence 91 angiograms were reevaluated. Special attention was paid to atherosclerotic and to focal occlusive arterial disease (> 50% stenosis) in the hypogastric-cavernous branch. 12 angiograms showed normal arteries, 59 typical atherosclerotic and 20 focal occlusive arterial disease. The mean age of patients with atherosclerosis was 53 +/- 8 years versus 35 +/- 14 years of those with focal lesions (p < 0.0001). 30% with focal arterial lesions were subject to subclinical trauma. 68% with atherosclerotic disease had clinical relevant atherosclerotic risk factors. Latency between onset of erectile dysfunction and presentation at the impotence clinic was 51 months in patients with focal lesions and 39 months in those with atherosclerotic disease (nonsignificant). We conclude that subclinical trauma of the hypogatric-cavernous arteries can induce focal arterial lesions with significant impairment of perfusion. This pathology may contribute to erectile dysfunction. These patients are significantly younger and they suffer from clinically evident impotence approximately 18 years earlier than patients whose impotence is clearly of atherosclerotic origin. Focal arterial lesions due to subclinical trauma are described for the first time as an etiology of erectile dysfunction. Further studies are needed to confirm these results.     

Self-esteem and depression in men who present with erectile dysfunction

Erectile dysfunction always has a psychologic component in addition to the underlying physical cause. The extent of depression and reduced self-esteem in patients who present with erectile dysfunction are explored in this study. Suggestions are given for how urologic nurses can overcome patients' fears and concerns.     

Comparative study of papaverine plus phentolamine versus prostaglandin E1 in erectile dysfunction

PURPOSE: We compared the efficacy and short-term adverse effects of 1 ml. 30 mg./ml. papaverine plus 0.5 mg./ml. phentolamine versus 1 ml. 30 micrograms./ml. prostaglandin E1 in patients undergoing pharmacological erection testing. MATERIALS AND METHODS: A total of 60 patients (mean age 58 years) with a history of sexual erectile dysfunction longer than 6 months was randomly classified into 6 groups to be tested 1 week apart with the 2 solutions and with placebo to evaluate erection response and short-term adverse effects. RESULTS: Of the patients tested with papaverine plus phentolamine 54% responded with erections adequate for penetration, compared to 50% of those tested with prostaglandin E1 (p > 0.05). Prolonged erection occurred in 18% of patients tested with papaverine plus phentolamine and 15% of those tested with prostaglandin E1 (p > 0.05). Pain was reported by 15 and 35% of patients, respectively (p < 0.05). CONCLUSIONS: One ml. 30 mg./ml. papaverine plus 0.5 mg./ml. phentolamine has the same efficacy and equal prolonged erection rate as 1 ml. 30 micrograms./ml. prostaglandin E1 but the latter agent induces significantly more pain.