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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT02041767
Eligibility Criteria:
Inclusion Criteria:
* Acceptance and understanding of the consent form (signed)
* 18-80 years old patients
* BPH needing endoscopic resection according to French Urology Association recommendations
* Procedure and follow up made in investigator center
* normal digital rectal examination
* PSA :
* patient \> 69 years old, not necessary
* patient \< 69 years old, PSA\<20 and if 4\<PSA\<20, the ratio free PSA/total PSA must be \>10%
* patient with renal clearance \>60 estimated with MDRD
* patient affiliated to the social security
Exclusion Criteria:
* personal or familial history of prostatic or genito-urinary cancer
* personal history of pelvic irradiation
* personal history of hormone-therapy
* personal history of prostatic adenomectomy by abdominal approach
* personal history of allergy to beta-lactamines
* urinary tract infection or bacterial colonisation at the time of procedure
* carbapenems treatment in the two weeks before surgery
* hyperresponsivness to ertapenem or other carbapenems antibiotic
* patient with renal clearance estimated with MDRD \<60
* patient with catheter or probe permanently
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02041767
Study Brief:
Protocol Section:
NCT02041767