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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT02869061
Eligibility Criteria:
Inclusion Criteria:
* Bladder neck contracture after transurethral prostate resection.
* Obstructive pattern of urine flow rate with maximum flow rate below 15 mL/s
* Patient is familiar with Participant information sheet
* Patient signed informed consent form
Non-inclusion Criteria:
* Contraindications for spinal, epidural or inhalation anesthesia
* Urethral strictures
* Genitourinary inflammatory diseases
* Prostate-specific antigen (PSA) level above 4 ng/mL
* Contraindications for local anesthesia or history of allergy for local anesthetics
* Systemic glucocorticoid and/or immunosuppressant therapy
* Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)
* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
* Clinically significant abnormalities in results of laboratory tests
* Patient received anticoagulants at least 12 hours prior the liposuction
* Medical history of heterotopic ossifications
* Patients prescribed for glycoprotein inhibitors treatment
Exclusion Criteria:
* Patient's refusal from the further participation in trial
* Chronic kidney disease IV- V stages (creatinine clearance \< 30 mL/min estimated by Cockcroft-Gault formula)
* Confirmed syphilis, HIV, hepatitis B or C infections
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02869061
Study Brief:
Protocol Section:
NCT02869061