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 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT01866995
Eligibility Criteria:
Inclusion Criteria:
* Age 20-60 years
* Symptoms of prostatostasis lasting for at least 3 months during the past 6 months:
* Pathological changes on uroflowmetry (maximum flow rate of less than 15 ml / s, average urinary flow rate of less than 12 ml / sec)
* TRUS Prostate volume more than 22 ml at TRUS
* TRUS picture of Prostatostasis
* I-PSS 7-20
* IIEF-5) - 12-21
Exclusion Criteria:
* Contraindications and limitations to use of the drug Raylis listed in the instructions for medical use \*
* Diabetes mellitus (type 1 and type 2, decompensation)
* Neurogenic disorders (acute cerebral circulatory disorders, Alzheimer's disease, spinal cord injury)
* A history of pelvic trauma
* Patients who had undergone radical prostatectomy and other surgical interventions on the pelvic organs
* Concomitant use of supplements to improve the erectile function, use of the anti-androgens, anti-depressants, finasteride.
* Diagnosed BPH
* Current participation in a clinical trial and / or study medication for 30 days prior to inclusion
* Any form of substance abuse, mental disorder or condition which, in the opinion of the investigator, may complicate communication with the researcher.
* The inability or unwillingness to comply with the scheme of visits according to protocol.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT01866995
Study Brief:
Protocol Section:
NCT01866995