metabolic syndrome and BPH patients who will undergo simple prostatectomy MedDRA version: 14.1 Level: LLT Classification code 10004447 Term: Benign prostatic hypertrophy System Organ Class: 100000004872
Conditions
Interventions
Trade Name: TOSTREX*GEL MULTID 60G 2%+DOSA
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Adult male subjects (=18 years old) who are planned fror simple prostatectomy for BPH 2. Diagnosis of Metabolic syndrome(according to AHA/NHLBI) 3. ddiagnosis of prostatic inflammation (NIH-CPSI score >15) 4. Able to understand the study procedures and to sign informed written consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Partecipation to another clinical study 2. Previous diagnosis of breast or prostatic cancer 3. PSA >4ng/mL 4. Hematocrit =52% 5. Use of 5alpha-reductase inhibitors in the previous 3 months ; 6. Psychiatruic disorders 7. Severe disease that unable the patient to partecipate to the study 8. Severe hypersensitivity to the drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effect of testosterone replacement tharapy on improving lower urinary tract symptoms in hypogonadal patients affected by BPH and metabolic syndrome;Secondary Objective: Evaluation of the effect of testosterone replacement tharapy in hypogonadal patients affected by BPH and metabolic syndrome on improving : 1- ultrasonographic features of prostate 2- prostatic inflammation 3- metabolic parameters 4- semen IL-8 level 5-sexual function 6- hypogonadism-related symptoms 7- urodynamic parametrs;Primary end point(s): Primary endpoint: to visit 4 each patient will be classified as success / failure based on the following criteria: successful improvement of the score in at least two of the three questionnaires (''NIH-CPSI,'' ''total IPSS'' and ''IPSS bother'') for the evaluation of symptoms related to inflammation protstatica, compared to the values ??observed at visit 1. For each questionnaire will be considered improved their score based on the following table: NIH-CPSI reduction of at least 2 points of the score to visit 4 compared to visit 1 Reduction of total IPSS score of at least 3 points to visit 4 compared to visit 1 Reduction in IPSS bother score of at least 1 point to visit 4 compared to visit 1 failure: failure to improve the score in at least two of the three questionnaires.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Volumetric change of the prostate: is calculated as the difference between the prostate volume measured at visit 4 and that measured at visit 1. The value of prostate volume is obtained by transrectal ultrasonography and measured using the planimetric method as described by Behre et al., 1995 and Vicari, 1999. Change in the number of macrocalcifications intraprostatiche: will be calculated as the difference between the number of macrocalcifications observed at visit 4 and those observed at visit 1. For macrocalcificazione means the presence of calcification of a diameter> 3 mm, as already reported by Dahnert et al., 1986, Dagash & Mackinnon, 2007, Isidori & Lenzi, 2008 and Lotti et al., 2011. Histological score of inflammation: will be given after surgery to prostatectomy, using immunohistochemical analysis. The degree of inflammation of the prostate will be measured through the use of a score based on the score of 'NHI (Nickel et al., 2001). The parameters of the score will be evaluated by optical microscopy of tissue obtained from the piece at the Institute of Surgical Pathology dell'AOU Careggi. Presence of MetS: In each patient, the diagnosis of MetS parameters will be reevaluated at visit 4, to confirm the presence or absence at the end of treatment. Variation of the concentration of IL-8 in the seminal liquid: it will be calculated as the difference between the value of the concentration of IL-8 in the seminal fluid measured at visit 4 and that measured at visit 1. The dose of IL-8 will be performed by Immuno-absorbent Assay for Enzyme linked (Enzyme-linked immunosorbent assay, ELISA) of fresh semen, collected at visit 1 and visit 4. Improvement of sexual function: for each patient is evaluated the presence of an improvement of sexual function to visit 4, defined as the increase of at least 3 points to the questionnaire IIEF-5, compared to the value observed at visit 1. The IIEF-5 assesses erectile function by 5 questions | — |
Countries
Italy
Contacts
Public ContactMed. della Sessualit? Andrologia
Azienda Ospedaliero-Universitaria Careggi
Outcome results
None listed