Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00890851
Eligibility Criteria:
Inclusion Criteria:
1. Man whose age is superior or egal to 45 and inferior or egal to 85 years
2. Patient presenting an anaesthetic risk of ASA 1 at 3
3. Patient accepting the protocol, in particular the return to residence with a sounder
4. Patient presenting a TUBA related to a HBP and lasting since more than 3 months
1. with a gene score higher superior or egal to 3
2. with a score IPS superior to 8
5. Patient presenting a prostate whose estimated weight is inferior or egal to 80g, without median lobe prevailing and whose transverse width lies between 34 and 80 mm.
6. Patient having a residue post mictional lower than 200cc.
7. Patient presenting a normal renal function
8. Patient having a result PSA £ 4 ng/ml, or negative biopsies if PSA \> 4 and \< 10 ng/ml
9. Patient having given his free and in writing lit assent
10. Patient affiliated to the Social security or an assimilated mode
11. Patient having stopped his treatment by 5 alpha reductase since at least a month (1)
Exclusion Criteria:
1. Patient presenting a urinary infection
2. Patient presenting an acute retention of urine
3. Patient presenting a neurological bladder and/or of an anomaly of the sphincter
4. Patient currently under anticoagulant treatment.
5. Patient currently under anti-inflammatory treatment.
6. Patient presenting an affection or a confirmed or suspected malignant tumour of the prostates or vegie.
7. Patient presenting an antecedent of surgery prostatic
8. Patient presenting of the biopsies prostate sufferers carried out less than 4 months before procedure TUNA
9. Patient introducing of the antecedents of vesical lithiasis, haematuria important, contracting of the urethra, stenosis of the vesical collar, pathologies of the bladder or sweetened diabetes affecting vesical operation,
10. Patient presenting a prosthesis in the zone being able to be affected by the procedure
11. Patient presenting a desire of fertility
12. Patient presenting an anorectal pathology
13. Patient presenting an allergy to the anaesthesia locale
14. Patient whose follow-up seems incompatible with the needs for the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT00890851
Study Brief:
Protocol Section:
NCT00890851