Lower Urinary Tract Symptoms Clinical Trial
Official title:
Effectiveness of Testosterone Replacement Therapy (TRT) on Prostatic Gland in Hypogonadal Patients Affected by Benign Prostatic Hyperplasia (BPH) and Metabolic Syndrome (MetS). Florence-PROTEST
There are many evidences in the literature showing that the metabolic syndrome (MetS) is
associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated
with both conditions, thus being one of the most probable pathogenetic factor underlying the
association between MetS & BPH / LUTS.
Preliminary evidences from observational clinical studies have shown that treatment with
testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower
urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the
investigators research group show in an experimental model of metabolic syndrome the
occurrence of marked inflammation and tissue remodeling of the prostate gland, which is
prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is
therefore a need for a clinical trial to demonstrate the effect of treatment with
testosterone replacement in reducing the inflammation of the prostate and its effectiveness
in improving the symptoms related to inflammation in patients with prostatic BPH associated
with metabolic syndrome and testosterone deficiency .
The aims of the present study is to evaluate the effectiveness of testosterone replacement
therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate
and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates
for radical prostatectomy simple.
For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by
questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and
assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score,
IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation:
macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines
in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis
of samples prostate derived from patients enrolled in the study or not treated with
testosterone) scores will be performed. Along with the symptoms and clinical signs of
prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile
erection will be also evaluated.
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