Ambulatory Blood Pressure Parameters Among Men With Hypogonadism Treated With Testosterone Transdermal Therapy.

Objective: Studies are needed to examine the effects of testosterone replacement therapy on ambulatory blood pressure (BP) parameters. This study assessed a testosterone transdermal system (TTS) using 24-hour ambulatory BP monitoring.

Methods: In a single-arm, noninferiority trial conducted at 41 US sites, 168 men (mean age: 56.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Purpose: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure.

Materials And Methods: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g.

Urinary Analysis of and Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.

Purpose: Cxbladder tests are urinary biomarker tests for detection of urothelial carcinoma. We developed enhanced Cxbladder tests that incorporate DNA analysis of 6 single nucleotide polymorphisms for the and genes, in addition to the current 5 mRNA biomarkers and clinical risk factors.

Materials And Methods: Two multicenter, prospective studies were undertaken in: (1) U.

Evaluating the safety and potential activity of URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced, placebo-controlled randomized phase 1 trials.

Aims: Two phase 1 trials were performed in healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO), with the aim to demonstrate the safety and potential efficacy of URO-902, which comprises a gene therapy plasmid vector expressing the human big potassium channel α subunit.

Methods: ION-02 (intravesical instillation) and ION-03 (direct injection) were double-blind, placebo-controlled, multicenter studies without overlap in enrollment between studies. Active doses were administered and evaluated sequentially (lowest dose first) for safety.

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial.

Aims: To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; "NMES") with an FDA-approved intravaginal device (iTouch sure; "comparator device") for the treatment of stress urinary incontinence (SUI).

Methods: This prospective, single-blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving >50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test.

Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement.

Purpose: These studies were undertaken to determine if fexapotide triflutate 2.5 mg transrectal injectable (FT) has significant long-term (LT) safety and efficacy for the treatment of benign prostatic hyperplasia (BPH).

Methods: Two placebo controlled double-blind randomized parallel group trials with 995 BPH patients at 72 sites treated 3:2 FT:placebo, with open-label FT crossover (CO) re-injection in 2 trials n = 344 and long-term follow-up (LF) 2-6.

EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM.

Objective: Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days.

Methods: This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency).

The efficacy, bioavailability and safety of a novel hydroalcoholic testosterone gel 2% in hypogonadal men: results from phase II open-label studies.

Pharmacokinetics, pharmacodynamics and safety of a novel hydroalcoholic testosterone gel 2% (TG) were evaluated in phase II sequential dose escalation studies using 3 application sites (thigh, abdomen and shoulder/upper arm) and 2 application methods. Hypogonadal men (n = 40), 18-75 years, with serum testosterone <300 ng dl(-1) were included in both studies. Study 1 evaluated hand-applied multiple doses of TG 1.

Effect of tadalafil once daily on prostate blood flow and perfusion in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, double-blind, multicenter, placebo-controlled trial.

Objective: To assess effects of tadalafil vs placebo on prostatic blood flow measured by transrectal ultrasonography in men aged ≥45 years with moderate-to-severe benign prostatic hyperplasia-lower urinary tract symptoms.

Methods: After screening and washout, patients were randomized to placebo (n = 50) or tadalafil 5 mg (n = 47) once daily for 8 weeks. Transrectal ultrasonography was performed at baseline, 4, and 8 weeks.

A green and black tea extract benefits urological health in men with lower urinary tract symptoms.

Objectives: The objective of this study was to examine the effects of a green and black tea extract blend [AssuriTEA Men's Health (AMH)] in men with lower urinary tract symptoms (LUTS).

Methods: In this randomized, double-blind, placebo-controlled study, 46 men aged 30-70 with an American Urologic Association symptom score (AUAss) of at least 8 and up to 24 were randomized to 500 mg AMH, 1000 mg AMH, or placebo daily for 12 weeks. Measurements were taken at baseline (BL), week 6 and week 12 for AUAss, simple uroflowmetry, postvoid residual volume (PVR), C-reactive protein (CRP), Short-Form 36 Health Survey (SF-36), and International Index of Erectile Function (IIEF).

A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia.

Purpose: We assessed the efficacy and tolerability of onabotulinumtoxinA 200 U vs placebo to treat lower urinary tract symptoms/benign prostatic hyperplasia in men previously treated with oral benign prostatic hyperplasia medication in a 24-week phase 2, multicenter, double-blind, randomized, placebo controlled, parallel group trial.

Materials And Methods: Patients with I-PSS (International Prostate Symptom Score) 14 or greater, peak urinary flow rate 4 to 15 ml per second and total prostate volume 30 to 80 ml were randomized 1:1 to a single intraprostatic treatment of onabotulinumtoxinA 200 U or placebo. A single-blind sham procedure followed by a 4-week run-in was included to attempt to minimize any potential placebo effect.

PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study.

Purpose: We evaluated the clinical usefulness of the PROGENSA® PCA3 Assay for predicting repeat prostate biopsy outcome.

Materials And Methods: Men with at least 1 prior negative prostate biopsy who were scheduled for repeat prostate biopsy based on best clinical judgment were enrolled at 14 centers. Whole blood and post-digital rectal examination urine samples were collected before extended template transrectal biopsy with 12 or more cores.

A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer.

Background: Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome.

Methods: This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score.

A phase 2 cancer chemoprevention biomarker trial of isoflavone G-2535 (genistein) in presurgical bladder cancer patients.

The soy compound genistein has been observed preclinically to inhibit bladder cancer growth with one potential mechanism being the inhibition of epidermal growth factor receptor phosphorylation (p-EGFR). A phase 2 randomized, placebo-controlled trial investigated whether daily, oral genistein (300 or 600 mg/d as the purified soy extract G-2535) for 14 to 21 days before surgery alters molecular pathways in bladder epithelial tissue in 59 subjects diagnosed with urothelial bladder cancer (median age, 71 years). G-2535 treatment was well tolerated; observed toxicities were primarily mild to moderate gastrointestinal or metabolic and usually not attributed to study drug.

Novel concentrated cranberry liquid blend, UTI-STAT with Proantinox, might help prevent recurrent urinary tract infections in women.

Objectives: To determine the safety, tolerability, maximal tolerated dose, and efficacy of a concentrated cranberry liquid blend, UTI-STAT with Proantinox, in female patients with a history of recurrent urinary tract infections (rUTIs).

Methods: The study agent was administered orally at 15, 30, 45, 60, and 75 mL daily for 12 weeks to women with a history of 2.78 ± 0.

Acute alcohol intake induces SOCS1 and SOCS3 and inhibits cytokine-induced STAT1 and STAT3 signaling in human monocytes.

Background: Acute alcohol consumption is associated with induction of immuno-inhibitory cytokines and down-regulation of pro-inflammatory responses to various pathogens. We previously reported that alcohol activates janus kinase/signal transducer and activator of transcription (JAK/STAT) signaling leading to IL-10 induction. The JAK-STAT pathway also activates its own negative regulators, suppressors of cytokine signaling (SOCS) 1 and SOCS3.

Urologic complications of high-dose chemotherapy and bone marrow transplantation.

Objective: This study reviews the incidence and management of cyclophosphamide-induced hemorrhagic cystitis in a group of patients who received high-dose chemotherapy and bone marrow transplantation.

Methods: The records of 217 consecutive patients undergoing bone marrow transplantation were reviewed. The incidence, degree, and management of hematuria in this group of pancytopenic and immunocompromised patients were recorded.

Interferons and interleukins in metastatic renal cell carcinoma.

Renal cell carcinoma is diagnosed frequently when it already has metastasized. The use of immunotherapy has provided a new source of drugs to be used in the therapy of renal cell carcinoma. Interferons were the first biologics to be evaluated demonstrating a response rate of 10-30 percent.

Unusual primary prostatic malignancies.

Atypical prostatic cancer is defined as any malignancy of prostatic origin, excluding the common acinar prostatic adenocarcinoma. These atypical prostate cancers account for less than 5 percent of all prostatic malignancies. Because atypical prostatic malignancies occur rarely, little is known about their biologic behavior.

Cyclophosphamide-induced hemorrhagic pyelitis and ureteritis associated with cystitis in marrow transplantation.

A 29-year-old woman suffered fatal hemorrhagic pyelitis, ureteritis and cystitis after receiving 4,800 mg./m.2 cyclophosphamide in preparation for marrow transplantation despite intravenous hydration and a Foley catheter.