Publications by authors named "Ted M Smith"
Objective: To elucidate patient characteristics that impact symptom-related bother and erectile function in patients with Peyronie disease (PD).
Methods: A post hoc analysis used data from patients with PD (ie, had PD symptoms ≥12 months and penile curvature deformity of 30-90 degrees) who received ≥1 injection of study medication in 2 phase 3 trials of collagenase clostridium histolyticum (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study I [n = 417] and Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study II [n = 415]). The Covariance Analysis of Linear Structural Equations procedure was used to estimate the potential relationship of specified variables on the level of distress and erectile dysfunction associated with PD as measured by the Peyronie's Disease Questionnaire and the International Index of Erectile Function, erectile function domain.
Objective: To evaluate the clinical usefulness of the Peyronie's Disease Questionnaire (PDQ). The relationship between subject-reported changes in PDQ psychosexual symptoms and clinical response to Peyronie's disease (PD) treatment was examined.
Materials And Methods: Combined data from the collagenase Clostridium histolyticum phase 3 study program, IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II, were examined.
Objective: To examine the safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies.
Patients And Methods: Patients from six clinical studies, including three randomised, double-blind, placebo-controlled studies and three open-label safety and efficacy studies, were included if they had received at least one dose of 0.58 mg CCH.
Objectives: To examine the efficacy of intralesional collagenase Clostridium histolyticum (CCH) in defined subgroups of patients with Peyronie's disease (PD).
Patients And Methods: The efficacy of CCH compared with placebo, assessed from baseline to week 52, was examined in subgroups of participants from the Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II. The subgroups were defined according to: severity of penile curvature deformity at baseline (30-60° [n = 492] and 61-90° [n = 120]); PD duration (1 to ≤2 [n = 201], >2 to ≤4 [n = 212] and >4 years [n = 199]); degree of plaque calcification (no calcification [n = 447], non-contiguous stippling [n = 103] and contiguous calcification that did not interfere with injection of CCH [n = 62]); and baseline erectile function (International Index of Erectile Function [IIEF] scores 1-5 [n = 22], 6-16 [n = 106] and ≥17 [n = 480]).
Introduction: In order to reliably assess treatment effectiveness, patient-reported outcome instruments must demonstrate adequate psychometric properties.
Aim: To assess the responsiveness of the Peyronie's Disease Questionnaire (PDQ) using data from two Phase 3 trials of collagenase clostridium histolyticum for Peyronie's disease (PD).
Methods: Both trials recruited adult males with PD who were in a stable relationship with a female partner for at least 3 months.
Introduction: The Peyronie's Disease Questionnaire (PDQ) is a disease-specific, patient-reported outcome instrument designed to measure the psychosexual consequences and treatment outcomes of Peyronie's disease (PD).
Aim: The aim of this study was to evaluate the test-retest reliability of the PDQ.
Methods: Adult men with PD were recruited through eight clinical sites across the United States.
Article Synopsis
- - The study investigates the effectiveness of Testim Gel 1% for increasing testosterone levels in hypogonadal men by applying it to different body sites (arms, chest, and legs) over a month each.
- - Results showed significant increases in total testosterone (TT) and calculated free testosterone (CT(free)) levels across the sites, with arms yielding the highest TT levels, while safety measurements for prostate and hemoglobin were stable.
- - The findings suggest that applying Testim Gel to different anatomical sites can effectively normalize testosterone levels, with similar effects observed regardless of the sequence of application sites.
It is recognized that testosterone (T) levels decrease in men with age, as does sexual function. We hypothesize that T supplementation in hypogonadal men with sexual dysfunction will restore certain elements of sexual function. Hypogonadal male subjects (total T < or = 300 ng/dL, n = 406, mean age 58 years) reporting one or more symptoms of low testosterone were randomized to T gel (50 mg/d and 100 mg/d), T patch, or placebo.
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