bluuebunny/crossref_metadata_2025_split huggingface dataset:
Vardenafil Improves Patient Satisfaction with Erection Hardness, Orgasmic Function, and Overall Sexual Experience, While Improving Quality of Life in Men with Erectile Dysfunction
Authors: Donatucci Craig , Taylor Terry , Thibonnier Marc , Bangerter Keith , Gittelman Marc , Casey Richard 
Published: September 2004

ABSTRACT

Purpose
The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED).

Materials and Methods
In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire.

Results
Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38%, 52%, 58% and 18%) and overall satisfaction (45%, 58%, 62% and 23%) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients’ answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10%, 22%, 21% and 4%), flushing (5%, 10%, 13% and 0%), dyspepsia (1%, 4%, 6% and &lt; 1%), and rhinitis (9%, 14%, 17% and 5%). Most AEs were mild or moderate in severity and transient in nature.

Conclusion
Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.
Determining the Earliest Time Within 30 Minutes to Erectogenic Effect After Tadalafil 10 and 20 mg: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, At-Home Study
Authors: Rosen Raymond C. , Padma-Nathan Harin , Shabsigh Ridwan , Saikali Khalil , Watkins Vish , Pullman William 
Published: September 2004

ABSTRACT

Introduction
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). The minimal time to onset of erectogenic effect in the at-home setting has not been evaluated.

Aim
The goal was to determine the earliest time to erectogenic effect leading to successful intercourse within 30 minutes after taking tadalafil 10 and 20 mg.

Methods
The multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase-2 study enrolled men at least 21 years old with a minimum 3-month history of ED. Four single doses each of placebo, tadalafil 10 mg, or 20 mg were taken at home once every 8–10 days. Using a stopwatch, couples recorded in Sexual Encounter Profile diaries the earliest time within 30 minutes after dosing to the first erection adequate for vaginal penetration, and whether the erection led to successful intercourse.

Main Outcome Measures
The primary analysis compared the percentage of erections resulting in successful intercourse between tadalafil groups and placebo at one-minute intervals using a step-down procedure. A secondary analysis compared the overall distribution of time to erectogenic effect between treatment groups using the Cox Regression Method.

Results
Compared to placebo, a significant erectogenic response to tadalafil 20 mg was found from 30 minutes down to 16 minutes after dosing (P = 0.012). Response to tadalafil 10 mg approached significance (P = 0.054) at 30 minutes. As analysed by the Cox Regression Method, a significant erectogenic response was found from 30 minutes down to 15 minutes after dosing for tadalafil 20 mg (P = 0.020), and from 30 minutes down to 26 minutes for tadalafil 10 mg (P = 0.042). Fifty-two percent of men taking tadalafil 20 mg had at least one successful intercourse attempt within 30 minutes compared to 35.1% of men taking placebo (P = 0.038).

Conclusions
This stopwatch-based study demonstrated a pharmacodynamic effect within 30 minutes after dosing for tadalafil 10 and 20 mg.
Efficacy and Safety of On-Demand Oral Tadalafil in the Treatment of Men with Erectile Dysfunction in Taiwan: A Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study
Authors: Chen Kuang-Kuo , Jiann Bang-Ping , Lin Johnny Shinn-Nan , Lee Shang-Sen , Huang Shih-Tsung , Wang Chii-Jye , Ju-Ton Hsieh , Su Chung-Kuang , Costigan Timothy M. , Emmick Jeffrey T. 
Published: September 2004

ABSTRACT

Introduction
Tadalafil is a phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (ED). Past clinical trials have assessed its efficacy and safety in western populations. Tadalafil has not been investigated in a large clinical trial with a South-east Asian population.

Aim
To assess the efficacy and safety of on-demand tadalafil for the treatment of ED in a 12-week, double-blind, placebo-controlled study in Taiwan.

Methods
Men with mild to severe ED of various etiologies were randomized to receive placebo, tadalafil 10 mg, or tadalafil 20 mg, taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ).

Results
Tadalafil significantly improved erectile function compared with placebo (P &lt; 0.005, all measures). At endpoint, the patients receiving tadalafil reported a greater mean per-patient percentage of successful intercourse attempts (SEP question 3: 70.0%, 10 mg; 78.0%, 20 mg) than placebo-treated patients (42.8%) and a greater proportion of improved erections (GAQ: 92.3% and 84.6% vs. 54.5%). Most treatment-emergent adverse events were mild or moderate. The most common adverse events were back pain, dyspepsia, and myalgia.

Conclusions
Tadalafil was an effective, well-tolerated therapy for men in Taiwan with ED of broad-spectrum severity and etiology.
Antibiotic Soaked Hydrophilic Coated Bioflex: A New Strategy in the Prevention of Penile Prosthesis Infection
Authors: Rajpurkar Atul , Fairfax Marilynn , Li Haikun , Dhabuwala Chirpriya B. 
Published: September 2004

ABSTRACT

Objectives
To find conditions that reduce the susceptibility of penile prostheses to infection, we studied the effect of coating the surface of polyurethane (Bioflex) with a hydrophilic material with and without antibiotics in decreasing bacterial colony counts both in vitro and in experiments in rats.

Materials and Methods
The in vitro experiment was performed using seven strips each of polyvinylpyrrolidone (PVP)-coated and uncoated polyurethane. These strips were dipped in saline for 5 minutes followed by incubation in a suspension of Staphylococcus epidermidis (SE) for a period of 10 minutes. Colony counts were determined after sonication of strips. For the in vitro experiments, 60 rats were used. Thirty animals each had uncoated or coated polyurethane implanted subcutaneously. In each group, strips were implanted after dipping them in either saline (N = 15) or an antibiotic solution (N = 15) consisting of 1 g/L vancomycin and 160 mg/L gentamicin. A bacterial suspension containing SE was then directly introduced into the subcutaneous pockets of all the animals prior to closure. After 7 days, strips were explanted along with 0.5 × 0.5 cm of surrounding tissue, and sonicated. Colony counts were performed on each sonicate. The data were analysed using Student's t-test. A P-value less than or equal to 0.05 was considered to be statistically significant.

Results
The in vitro study demonstrated a statistically significant (41%) reduction in the colony count of SE within the coated polyurethane strips compared to the uncoated Bioflex strips (150 ± 44.7 CFU vs. 253 ± 45.0 CFU, respectively, P-value &lt; 0.05). Animal studies showed that bacterial CFU was highest in the uncoated Bioflex strip (29 ± 24.5 CFU), followed by uncoated Bioflex with antibiotic treatment (24 ± 28.1 CFU), coated Bioflex (17 ± 25.2 CFU) and coated Bioflex with antibiotic treatment (13 ± 16.1 CFU). Antibiotic treatment of coated Bioflex caused a significant reduction in the bacterial CFU compared to uncoated Bioflex (13 ± 16.1 vs. 29 ± 24.5 CFU, respectively, P = 0.04). This represents a 55% reduction in the bacterial count. While the reduction in the bacterial count in the coated Bioflex strip was not statistically different from that in the uncoated strip, a trend towards significance was noted with a 41% reduction (P &gt; 0.05) in bacterial count in the coated Bioflex group compared to uncoated Bioflex.

Conclusions
In conclusion, in vitro studies demonstrate a significant (41%) reduction in the colony count of SE in PVP-coated polyurethane compared to uncoated polyurethane. In vivo study in rats showed that antibiotic treatment of PVP-coated Bioflex resulted in a statistically significant reduction (55%) in colony count of SE compared to uncoated Bioflex.
The Hydrophilic-Coated Inflatable Penile Prosthesis: 1-Year Experience
Authors: Wolter Christopher E. , Hellstrom Wayne J.G. 
Published: September 2004

ABSTRACT

Introduction
Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, Santa Barbara, CA) is coated with polyvinylpyrrolidone (PVP), a hydrophilic substance that reduces bacterial adherence and absorbs and elutes the antibiotics the device is immersed in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor.

Materials and Methods
Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated Alpha-1 IPPs implanted over the same time period. Infection rates were compared, along with bacterial culture data. All data were collected from Mentor's internal database, as generated from the FDA's mandatory reporting of explanted medical devices, and available on the internet.

Results
The infection rate for the coated Titan IPP was 1.06% (25/2357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1).

Conclusions
At  1 year  of  follow-up,  the  data  demonstrate  that  the  hydrophilic  coating  on  the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for prosthetic surgery. Nevertheless, the theoretical reduction in bacterial adhesion conferred by the hydrophilic PVP surface and the ability to choose which antibiotic the device is immersed in intraoperatively gives the implanting surgeon distinct advantages with this new product.
Self-Reported Premature Ejaculation and Aspects of Sexual Functioning and Satisfaction
Authors: Rowland David , Perelman Michael , Althof Stanley , Barada James , McCullough Andrew , Bull Scott , Jamieson Carol , Ho Kai-Fai 
Published: September 2004

ABSTRACT

Background
Although premature ejaculation (PE) is a common male sexual dysfunction, its relevant parameters have not been adequately studied in large community-based samples.

Objective
To examine the diagnostic utility of two self-report questions based on the DSM-IV-TR definition of PE and to investigate the relationship between self-identified PE, sexual functioning, and sexual satisfaction in men.

Methods
An Internet survey of general health and aspects of sexual functioning and satisfaction was conducted in 2056 males. Subjects were classified as having “probable” or “possible” PE, or as “non-PE” by survey responses.

Results
A total of 1158 men met the selection criteria (sexually active in a stable heterosexual relationship), and 189 (16.3%) were classified as having probable PE by reporting they ejaculated before they wished and indicating it was “very much” or “somewhat” a problem. Another 188 (16.2%) men reported ejaculating before they wished but rated their distress lower and were classified as having possible PE. Compared to non-PE men, those with probable and possible PE reported significantly worse sexual functioning in 6 of 8 study measures. Concern about partner satisfaction was high in all groups. The importance of ejaculatory control and the ability to have intercourse for the desired time was significantly higher in men with PE as compared to non-PE men (P &lt; 0.01).

Conclusions
PE was a common problem, was characterized by a lack of ejaculatory control, and was associated with significant effects on sexual functioning and satisfaction. Additional research on the sensitivity and specificity of these self-report questions should be pursued.
A Two-Temperature Model for the Analysis of Passive Thermal Control
Systems
Authors: Krishnan Shankar , Murthy Jayathi Y. , Garimella Suresh V. 
Published: September 2004

Abstract
Passive control of steady and unsteady thermal loads using effective thermal conductivity enhancers, such as metal foams, internal fins and metal filler particles, is being explored for a variety of electronics applications. The interstices are filled with air, phase change materials, or other fluids. Local thermal equilibrium between the solid filler and the matrix is not ensured in such systems since their thermal diffusivities are frequently very different. The use of a single volume-averaged energy equation for both the phases cannot be justified in such situations. A two-medium approach is used in the present work to account for the local thermal non-equilibrium. Separate energy equations are written for the solid and fluid respectively, and are closed using a steady-state interphase heat transfer coefficient between the two phases. A general momentum equation which includes the Brinkman-Forchheimer extension to Darcy flow is employed. The resulting equations are solved implicitly using a fully transient method on fixed orthogonal co-located finite volumes. Unsteady natural convection in a metal-foam filled cavity is computed. The influence of various parameters such as the ratios of solid-to-fluid thermal conductivities and heat capacities, Rayleigh number, Prandtl number and Darcy number on the thermal and flow fields is investigated. The results illustrate that local thermal equilibrium is not assured, either during the transient or at steady state for the range of parameters considered. Furthermore, even if the steady-state solid-to-fluid temperature differences are small, large temperature differences are seen during the unsteady response.
Melting Heat Transfer Characteristics of Microencapsulated Phase
Change Material Slurries With Plural Microcapsules Having Different Diameters
Authors: Inaba Hideo , Kim Myoung-Jun , Horibe Akihiko 
Published: September 2004

Abstract
The present study has been performed for obtaining the heat transfer enhancement characteristics of the plural microencapsulated solid-liquid phase change materials (PCM) slurry having different sizes, which flows in a straight tube heated under a constant wall heat flux condition. In the turbulent flow region, the friction factor of the plural PCM slurry was found to be lower than that of pure water flow due to the drag reducing effect of the PCM slurry. The heat transfer coefficient of the plural PCMs slurry flow in the tube was increased by both effects of latent heat evolved in phase change process and micro-convection around plural microcapsules with different diameters. The experimental results revealed that the average heat transfer coefficient of the plural PCMs slurry flow was about 2∼2.8 times greater than that of a single phase of water.
Experimental Investigation of the Potential of Metallic Porous
Inserts in Enhancing Forced Convective Heat Transfer
Authors: Pavel Bogdan I. , Mohamad Abdulmajeed A. 
Published: September 2004

Abstract
The present experimental work investigates the effect of a metallic porous matrix, inserted in a pipe, on the rate of heat transfer. The pipe is subjected to a constant and uniform heat flux. The effects of porosity and thickness of the porous matrix on the heat transfer rate and pressure drop are investigated. That is, the surface temperature distribution along a heated section of the pipe, the pressure drop over this section, as well as the inlet temperature of the air were continuously monitored with a data acquisition system and recorded when steady-sate conditions were attained. The results obtained for a range of Reynolds numbers 1000–4500, comprise both laminar and turbulent regime. Also, the results are compared with the clear flow case where no porous insert was used. It is shown that higher heat transfer rates are achieved when using porous inserts at the expense of a reasonable pressure drop, which depends on the permeability of the porous matrix.
Effect of Squealer Geometry on Tip Flow and Heat Transfer for a
Turbine Blade in a Low Speed Cascade
Authors: Saxena Vikrant , Ekkad Srinath V. 
Published: September 2004

Abstract
A detailed investigation on the effect of squealer geometries on the blade tip leakage flow and associated heat transfer is presented for a scaled up high pressure turbine blade in a low-speed wind tunnel facility. The linear cascade is made of four blades with the two corner blades acting as guides. The tip profile of a first stage rotor blade is used to fabricate the two-dimensional blade. The wind tunnel accommodates an 116° turn for the blade cascade. The mainstream Reynolds number based on the axial chord length based on cascade exit velocity is 4.83×105. An upstream wake effect is simulated with a spoked wheel wake generator placed upstream of the cascade. A turbulence grid placed even farther upstream generates a free-stream turbulence of 4.8%. The center blade has a tip clearance gap of 1.56% with respect to the blade span. Static pressure measurements are obtained on the blade surface and the shroud. Results show that the presence of the squealer alters the tip gap flow field significantly and produces lower overall heat transfer coefficients. The effects of different squealer arrangements are basically to study the effect of squealer rim placement on tip leakage flow and associated heat transfer. Detailed heat transfer measurements are obtained using a steady state liquid crystal technique. The effect of periodic unsteady wake effect is also investigated by varying the wake Strouhal number from 0–0.4. Results show that suction side squealers may be favorable in terms of overall reduction in heat transfer coefficients over the tip surface. However, the presence of a full squealer is most beneficial in terms of reducing overall heat load on the tip surface. There is reasonable effect of wake induced periodicity on tip heat transfer.
An Experimental Investigation of Flow Boiling Characteristics of Water in Parallel Microchannels
Authors: Steinke Mark E. , Kandlikar Satish G. 
Published: September 2004

AbstractMicrochannels are being considered in many advanced heat transfer applications including automotive and stationary fuel cells as well as electronics cooling. However, there are a number of fundamental issues from the heat transfer and fluid mechanics perspectives that still remain unresolved. The present work focuses on obtaining the fundamental heat transfer data and two-phase flow patterns present during flow boiling in microchannels. An experimental investigation is performed for flow boiling using water in six parallel, horizontal microchannels with a hydraulic diameter of 207 μm. The ranges of parameters are: mass flux from 157 to 1782 kg/m2s, heat flux from 5 to 930 kW/m2, inlet temperature of 22°C, quality from sub-cooled to 1.0, and atmospheric pressure at the exit. The corresponding single-phase, all-liquid flow Reynolds number range at the saturation conditions is from 116 to 1318. The measured single-phase, adiabatic pressure drop agreed with the conventional theory within the experimental error. The experimental single-phase Nusselt number was found to be between the constant heat flux and the constant wall temperature boundary conditions, corresponding to NuH and NuT respectively. The flow visualization demonstrates that the flow reversal condition in parallel flow channels is due to bubble nucleation followed by its rapid growth. In addition, the dry-out condition is observed, showing a change in the contact angles of the liquid-vapor interface. The local flow boiling heat transfer coefficient exhibits a decreasing trend with increasing quality. A comparison with the nucleate boiling dominant regime of a flow boiling correlation shows good agreement, except for the large peak in two-phase heat transfer coefficient observed at the onset of nucleate boiling.
The Complex Flagellar Torque Generator of
Pseudomonas aeruginosa
Authors: Doyle Timothy B. , Hawkins Andrew C. , McCarter Linda L. 
Published: September 2004

ABSTRACT

Flagella act as semirigid helical propellers that are powered by reversible rotary motors. Two membrane proteins, MotA and MotB, function as a complex that acts as the stator and generates the torque that drives rotation. The genome sequence of
Pseudomonas aeruginosa
PAO1 contains dual sets of
motA
and
motB
genes, PA1460-PA1461 (
motAB
) and PA4954-PA4953 (
motCD
), as well as another gene,
motY
(PA3526), which is known to be required for motor function in some bacteria. Here, we show that these five genes contribute to motility. Loss of function of either
motAB
-like locus was dispensable for translocation in aqueous environments. However, swimming could be entirely eliminated by introduction of combinations of mutations in the two
motAB
-encoding regions. Mutation of both genes encoding the MotA homologs or MotB homologs was sufficient to abolish motility. Mutants carrying double mutations in nonequivalent genes (i.e.,
motA motD
or
motB motC
) retained motility, indicating that noncognate components can function together.
motY
appears to be required for
motAB
function. The combination of
motY
and
motCD
mutations rendered the cells nonmotile. Loss of function of
motAB
,
motY
, or
motAB motY
produced similar phenotypes; although the swimming speed was only reduced to ∼85% of the wild-type speed, translocation in semisolid motility agar and swarming on the surface of solidified agar were severely impeded. Thus, the flagellar motor of
P. aeruginosa
represents a more complex configuration than the configuration that has been studied in other bacteria, and it enables efficient movement under different circumstances.