Clinical Research 2021.

Clinical research is of great benefit to patients and rewarding to clinicians. Clinical research in the United States is highly regulated. There are significant penalties for violating protocols.

Efficacy of Testosterone Suppression with Sustained-Release Triptorelin in Advanced Prostate Cancer.

Introduction: Androgen deprivation therapy (ADT) is a mainstay of treatment against advanced prostate cancer (PC). As a treatment goal, suppression of plasma testosterone levels to <50 ng/dl has been established over decades. Evidence is growing though that suppression to even lower levels may add further clinical benefit.

Impact of low testosterone on response to treatment with tadalafil 5 mg once daily for erectile dysfunction.

Objective: To evaluate, posthoc, the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction (ED).

Methods: Men were aged ≥18 years, with ≥3-month history of ED and partial prior response to on-demand (PRN) phosphodiesterase type 5 inhibitor (PDE5I) therapy. A 4-week maximum-dose PRN PDE5I run-in was followed by a 4-week nondrug washout period, then randomization to tadalafil 2.

Efficacy and safety of oxybutynin topical gel 3% in patients with urgency and/or mixed urinary incontinence: a randomized, double-blind, placebo-controlled study.

Aims: To assess the efficacy and safety of oxybutynin transdermal gel 3% (OTG3%), with propylene glycol for enhanced skin permeation, in patients with urinary incontinence (UI).

Methods: In this phase 3 study, 626 patients ≥18 years old with urgency and/or mixed UI symptoms and predominantly urgency UI for ≥3 months were randomized 1:1:1 to receive 12 weeks of OTG3% 84 mg, OTG3% 56 mg, or placebo gel applied once daily to abdomen, inner/upper thigh, or upper arm/shoulder. Primary efficacy endpoint was change from baseline to Week 12 in weekly UI episodes recorded in 3-day bladder diaries.

Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies.

Objective: To assess the efficacy and safety of tadalafil, a phosphodiesterase 5 (PDE5) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH), in population subgroups, using pooled data from 4 international, randomized, placebo-controlled studies in men with LUTS/BPH.

Methods: The safety database included 1500 men randomized to tadalafil 5 mg once daily or placebo for 12 weeks. Changes in total International Prostate Symptom Score (IPSS), IPSS-quality of life index, and BPH impact index were examined overall, and changes in IPSS or adverse events (AEs) were examined across subgroups of interest.

A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy.

Introduction: An optimal outcome of an erectile dysfunction (ED) treatment is to enable a return to normal erectile function (as defined by an International Index of Erectile Function-Erectile Function [IIEF-EF] domain score ≥ 26). As-needed (PRN) phosphodiesterase type 5 (PDE5) inhibitor treatment does not always result in a return-to-normal erectile function.

Aim: The combined studies evaluated whether treatment with tadalafil once daily would allow men to return to normal erectile function who had less than normal IIEF-EF domain scores while using a maximum dose of a PRN PDE5 inhibitor treatment.

Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial.

Introduction: Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD).

Aim: To assess the efficacy and safety of flibanserin over 24 weeks of double-blind treatment vs. placebo in premenopausal women with HSDD who showed a predefined response after 24 weeks of open-label treatment with flibanserin.

Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1-year, open-label extension study.

Objective: • To evaluate the 1-year safety of 5 mg of tadalafil once daily in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS); efficacy measures were included to evaluate the maintenance of efficacy after an additional year of treatment.

Patients And Methods: • In total, 427 men who completed a 12-week, placebo-controlled, dose- finding study assessing once-daily tadalafil (2.5, 5, 10 or 20 mg) or placebo elected to continue into the open-label extension period.

Patient-optimized doses of fesoterodine improve bladder symptoms in an open-label, flexible-dose study.

Objective: To assess changes in overactive bladder (OAB) symptoms and patient-reported outcomes in a post hoc analysis in which subjects from a 12-week, open-label, flexible-dose fesoterodine study were stratified according to whether they opted for dose escalation.

Patients And Methods: Subjects with OAB (eight or more micturitions and three or more urgency episodes per 24 h) who reported dissatisfaction with tolterodine within 2 years of screening received fesoterodine 4 mg once daily for 4 weeks, with an optional dose increase to 8 mg after week 4 based on discussion of efficacy and tolerability between the subject and investigator. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12, and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12.

Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes.

Objective: In the few studies to evaluate antimuscarinics for overactive bladder (OAB) in men, safety has been the primary focus. In OAB efficacy trials, subject populations have been predominantly female and patient-reported outcomes (PROs) have been assessed only recently. We present a post hoc analysis of PRO-based findings from the subset of men (without presumed bladder outlet obstruction [BOO]) from two large, independent, open-label trials of solifenacin.

Assessing the impact of ureteral stent design on patient comfort.

Purpose: We assessed the near term comfort of newly designed ureteral study stents or marketed control stents, including Polaris and Percuflex stents. Study stents had distal 6Fr pigtail ends with 3Fr or less loops. Decreased material in situ was hypothesized to enhance comfort.

Validation of the decreased sexual desire screener (DSDS): a brief diagnostic instrument for generalized acquired female hypoactive sexual desire disorder (HSDD).

Introduction: An accurate diagnosis of Hypoactive Sexual Desire Disorder (HSDD) currently relies on a time-consuming interview with an expert clinician. Limited access to such expertise means that many women with HSDD remain undiagnosed. The Decreased Sexual Desire Screener (DSDS) was developed to provide clinicians who are neither trained nor specialized in Female Sexual Dysfunction (FSD) with a brief diagnostic procedure for the diagnosis of generalized acquired HSDD in women.

Changes in urine volume accomplished by physicians treating nephrolithiasis.

Purpose: We quantified the changes in urine volume and sodium accomplished in various practice settings and the consequent effects on calcium oxalate supersaturation.

Materials And Methods: We determined comprehensive urine stone risk factors in 2,877 patients treated in 14 practices, including a university referral center and private sector practices. Changes in urine volume and stone risk factors were measured.