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Biomedical subjects

R L Siegel

Publications and source records attributed to R L Siegel.

At least 19 recordsLinked to original sources

Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire.

OBJECTIVES: To assess the efficacy and safety of Viagra (sildenafil citrate) in male outpatients with erectile dysfunction and patient and partner satisfaction with treatment using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). METHODS: A total of 247 patients with erectile dysfunction of broad-spectrum etiology were treated in a randomized, double-blind, parallel-group, multicenter study conducted at outpatient clinics. Patients receiving oral sildenafil (25, 50, and 100 mg) were compared with patients receiving placebo during a 12-week period. The principal efficacy measures were responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) on the International Index of Erectile Function and three global efficacy questions. Patient and partner satisfaction with treatment were assessed, for the first time, using the EDITS questionnaire. RESULTS: Efficacy scores for the International Index of Erectile Function questions and the global efficacy questions were significantly higher for patients receiving sildenafil than for those receiving placebo (P <0.001). Both patients and partners receiving sildenafil also had significantly higher EDITS scores than those receiving placebo (P <0.001). Adverse events were chiefly mild or moderate. Two patients receiving sildenafil and none receiving placebo discontinued treatment because of adverse events. CONCLUSIONS: Sildenafil was an effective, well-tolerated treatment for erectile dysfunction in an outpatient setting. Partner evaluations corroborated patient assessments. The results from the EDITS questionnaire indicated that after 12 weeks of receiving sildenafil both patients and partners reported higher levels of treatment satisfaction relative to placebo.

Adult↗

Characterization of radial forces in Z stents.

RATIONAL AND OBJECTIVES: The purpose of this study was to evaluate the effects of variation in design parameters on the resultant radial force. We evaluated the influence of wire gauge, leg length, and number of bends on the radial force produced by z stents and compared these with radial forces produced by commercial stents. A second goal was to develop an engineering model for predicting radial forces generated by z stents. METHODS: Z stents were fashioned by hand using stainless steel wire and solder that connected the ends. The radial force was measured as a function of wire gauge, vessel diameter, leg length, and number of bends and compared with the theoretical values of radial force calculated by combining Castigliano's theorem and the law of Laplace. RESULTS: Theoretically predicted radial forces were within 8% of each observed value of radial force up to 70% spring compression. CONCLUSIONS: These results suggest that the z-stent model can be used to build custom stents with preselected values of radial force for clinical use. In addition, they can be used to design model investigational stents made of similar materials and surface areas to test the effects of radial force on biological response.

Biomechanical Phenomena↗

Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors.

OBJECTIVE: This study was an evaluation of whether sildenafil citrate is effective for the treatment of erectile dysfunction in men taking concomitant serotonin-reuptake-inhibiting antidepressants. METHOD: A retrospective subanalysis of combined data from 10 phase II/III double-blind, placebo-controlled, fixed- and flexible-dose trials (12-26 weeks) identified a group of men with erectile dysfunction receiving 5 to 200 mg/day of sildenafil (N=65) or placebo (N=33) and concomitant serotonin-reuptake-inhibiting antidepressants. Efficacy was measured by responses to questions from the International Index of Erectile Function on ability to achieve erection, ability to maintain erection, ejaculation frequency, orgasm frequency, and sexual desire. RESULTS: Patients with erectile dysfunction receiving sildenafil and concomitant serotonergic antidepressants had significantly greater improvements in ability to achieve and maintain an erection, frequency of ejaculation, and orgasm frequency than did patients receiving placebo, without increased sexual desire. CONCLUSIONS: Sildenafil significantly improved erectile dysfunction in patients taking concomitant serotonergic antidepressants.

Major Depressive Disorder↗

Relationship between patient self-assessment of erectile function and the erectile function domain of the international index of erectile function.

OBJECTIVES: To assess the validity of severity classes on the erectile function (EF) domain of the International Index of Erectile Function by determining their relationship with the self-assessment of EF, before and after treatment, in an independent cohort of patients. METHODS: Two hundred forty-seven men with clinically diagnosed erectile dysfunction (ED) and in a stable heterosexual relationship were enrolled in a randomized, double-blind, multicenter, placebo-controlled, parallel-group, 12-week, flexible-dose study. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after treatment. They also responded to the six questions of the EF domain, with the total score indicating the following degrees of ED: severe, EF score 1 to 10; moderate, EF score 11 to 16; mild to moderate, EF score 17 to 21; mild, EF score 22 to 25; and no ED, EF score 26 to 30. Descriptive profiles of the two diagnostic instruments were compared. The correlations between the instruments were evaluated with Kendall's tau-b at baseline, after treatment at 12 weeks, and at change from baseline. RESULTS: The two measures gave generally similar descriptive profiles of ED severity. The correlations were 0. 65 (95% confidence interval 0.57 to 0.73) at baseline, 0.86 (95% confidence interval 0.83 to 0.89) after 12 weeks of treatment, and 0. 73 (95% confidence interval 0.67 to 0.79) at change from baseline. CONCLUSIONS: The moderate-to-high correlation between the patients' self-assessment of EF and the EF domain of the International Index of Erectile Function provides a validation of this domain for the reliable diagnostic classification of ED severity.

Adult↗

A multicenter, community-based study of doxazosin in the treatment of concomitant hypertension and symptomatic benign prostatic hyperplasia: the Hypertension and BPH Intervention Trial (HABIT).

As men age, the incidence of both benign prostatic hyperplasia (BPH) and hypertension increases. Concomitant occurrence of these conditions also increases with age, and the 2 are frequently encountered together in primary care practice. In addition, many patients with hypertension require >1 antihypertensive agent to adequately control blood pressure. In a multicenter, community-based, 8-week, uncontrolled, open-label study, we evaluated doxazosin, a selective alpha1-adrenergic-receptor antagonist, in 491 patients with concomitant symptomatic BPH (American Urological Association [AUA] symptom score > or =12) and hypertension, some previously untreated and some with inadequately controlled hypertension (systolic blood pressure 120-179 mm Hg or diastolic blood pressure [DBP] 80-109 mm Hg) despite taking 1 or 2 antihypertensive agents. Patients were allocated to 1 of 4 groups at baseline according to their diastolic blood pressure (control was considered DBP <90 mm Hg) and whether they had received antihypertensive medication before the study. Thus the 4 groups were treated/well-controlled, treated/poorly controlled, untreated/hypertensive, and untreated/normotensive. In all patient groups, doxazosin therapy significantly improved AUA total symptom and bothersomeness scores and BPH-specific indices of health status and interference with activities (P<0.001). Significant improvements in BPH symptoms were observed with doxazosin, regardless of whether initial symptoms were moderate or severe (P<0.001). Clinically important blood pressure lowering occurred only in the patient groups in which blood pressure had been elevated at baseline. Patients whose blood pressure was poorly controlled at baseline, either without or with treatment (predominantly with angiotensin-converting enzyme inhibitors or calcium channel blockers), achieved adequate blood pressure control (reduction to <140/90 mm Hg) with the addition of doxazosin. Similar improvements in blood pressure and BPH symptoms were seen in both older (> or =65 years) and younger (45 to 64 years) patients, and doxazosin was well tolerated by both groups. The most frequent treatment-related adverse event was dizziness (13.0% of patients); however, patients classified the dizziness as mild in approximately 75% of reports, and severe dizziness was reported by only 2 patients (0.4%). Doxazosin is an effective antihypertensive agent when used in combination with agents from other antihypertensive classes in patients with poorly controlled hypertension and BPH, and is also successful as monotherapy for controlling both BPH and hypertension in patients with mild to moderate hypertension.

Adrenergic alpha-Antagonists↗

Endovascular management of ureteroarterial fistula.

Ureteroarterial fistulas, although rare, appear to be increasing in frequency. Because open surgical repair may be difficult and associated with significant risk for complications, endovascular intervention may provide an attractive treatment alternative. We review the diagnosis and management of a ureteroarterial fistula and iliac pseudoaneurysm that presented with massive hematuria during ureteral stent removal. The patient was treated by means of the percutaneous embolization of the right hypogastric artery and placement of an expanded polytetrafluoroethylene stent-graft. Endovascular stent-graft placement may serve as a safe and practical alternative in the treatment of these patients, whose cases are challenging.

Angiography, Digital Subtraction↗

Access to occluded infrainguinal bypass grafts with a loopsnare.

Thrombolysis for the treatment of occluded bypass grafts is used in selected clinical circumstances. Unfortunately, a minority of these procedures are technical failures because of the inability to access the occluded graft. We describe a technique that greatly increases the chances of technical success.

Aged↗

Endovascular stent graft for management of ureteroarterial fistula after orthotopic bladder substitution.

We describe the first case of an ureteroarterial fistula developing after orthotopic neobladder substitution and its minimally invasive management using endovascular stent grafting. We outline the risk factors for the development of ureteroarterial fistulae and trace the evolution of diagnostic and therapeutic modalities used in the management of these life-threatening complications. Minimally invasive management with endovascular stent grafting and exclusion of two pseudoaneurysms in the iliac artery system was performed successfully. After successful endovascular exclusion of two pseudoaneurysms, the patient's hematuria resolved and he recovered fully. Three-dimensional computed tomography performed 3 months later documented a patent aortoiliac arterial system without evidence of pseudoaneurysm or endovascular leak. Ureteroarterial fistula after orthotopic bladder substitution was managed with an endovascular stent graft without the need for extra-anatomical vascular bypass. Early recognition, stabilization, and angiographic evaluation followed by this minimally invasive technique may avoid open operative repair and attendant morbidity.

Cystectomy↗

Ultrasound characteristics of subdermally implanted Implanon contraceptive rods.

This study was designed to define sonographic characteristics and the optimal sonographic technique for localization of the single rod Implanon system. Diagnostic ultrasonography was performed in eight women who had the Implanon rod implanted in the medial aspect of the upper arm. All implants were scanned in the longitudinal and transverse direction using 3.5 MHz, 5 MHz, and 7.5 MHz linear array transducers. Scanning was performed both directly against the skin and with 2 and 4 cm Kiteco ultrasound stand-off pads. Each image obtained was evaluated for detectability of the Implanon rod and the grade of acoustic shadowing produced by the Implanon rod by two independent observers. Discrepancies in evaluation were adjudicated by a third observer. The Implanon rod implant was not directly identified using the transducer and standoff pad combinations. Implanon rods were indirectly identified as a result of the posterior acoustic shadow cast by the Implanon. Best demonstration was achieved with the 5 or 7.5 MHz transducer and a 2 cm stand-off pad in the transverse direction. Appropriate ultrasonographic technique and familiarity with posterior acoustic shadowing patterns generated by the implant provide a noninvasive method for localization of nonpalpable, single rod implants prior to removal.

Arm↗

Safety and efficacy of doxazosin in benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies.

OBJECTIVES: To present the results of a pooled analysis of three double-blind, placebo-controlled studies of doxazosin in benign prostatic hyperplasia (BPH). Heterogeneous symptom and bother score data collected using different symptom indices were transformed to enable a comparison of the data and to conduct a pooled, in-depth analysis. METHODS: Urinary flow rates, and symptom and bother score data were shown by analysis of covariance methods to give consistent estimates of the efficacy of doxazosin across different studies, thus confirming the validity of pooling the results. Prior to analysis, symptom and bother score data were transformed so that all scales started from zero (least symptoms or bother) and were expressed as a percentage of the maximum score. RESULTS: Doxazosin produced a significantly greater improvement than placebo in peak urinary flow rate (P = 0.0017), symptom severity (P < 0.0001), and bother caused by symptoms (P < 0.0001). Stratification showed that a greater improvement was obtained during doxazosin treatment by those with more severe symptoms at baseline (P = 0.0001). Stratification by age showed that age did not affect the capacity to benefit from treatment. Analysis of the pooled peak flow-rate data showed that doxazosin produced a consistently greater increase in flow compared with placebo. Doxazosin was well tolerated, with 10% of patients having withdrawn due to adverse events versus 4% with placebo (P < 0.05). CONCLUSIONS: Doxazosin is well tolerated and effective in the treatment of BPH. Pooling of data has enabled more extensive and robust conclusions to be drawn than was possible for each one of the individual three studies.

Adrenergic alpha-Antagonists↗

Peritoneal dialysis catheters: repositioning with new fluoroscopic technique.

From April 1990 to December 1992, the authors evaluated a new technique for radiologic manipulation of malfunctioning peritoneal dialysis catheters (PDCs). In 25 patients (16 male and nine female patients, aged 15-81 years), 25 PDCs were fluoroscopically manipulated 38 times for failure to drain (n = 22) or painful dialysis (n = 3). The PDC was backed out of its initial position with use of a wire and stiffener. Immediate success was obtained in 34 of 38 manipulations (89%), 21 manipulations (55%) were successful at 1 week, and durable success (function for more than 1 month or until the catheter was no longer needed) was achieved in 16 manipulations (42%). This is an effective alternative procedure to surgical catheter replacement or hemodialysis.

Adolescent↗

Tunneled central venous access catheter placement in the pediatric population: comparison of radiologic and surgical results.

PURPOSE: To compare the success and infection rates of radiologic placement with those of surgical placement of tunneled central venous access catheters (TCVACs) in infants and small children. MATERIALS AND METHODS: In 17 pediatric patients, TCVACs were placed with vascular access under ultrasound or fluoroscopic guidance in the radiology department. In 29 other patients, TCVACs were placed with percutaneous puncture or surgical cutdown in the surgery department. RESULTS: Two (11%) of 18 attempts at radiologic placement were unsuccessful; six (38%) of the 16 radiologically placed catheters necessitated removal because of dislodgment, malfunction, or infection; six (38%) were electively removed; and four (25%) still function. Eight (23%) of 35 attempts at surgical placement were unsuccessful; 17 (63%) of the 27 surgically placed catheters required removal because of dislodgment, malfunction, or infection; nine (33%) were electively removed; and one (4%) still functions. CONCLUSION: The success and infection rates of radiologic placement of TCVACs were similar to those of surgical placement. Radiologic placement required fewer attempts and was slightly less expensive.

Adolescent↗