Effects of Proxelan Somministration in Patients With Chronic Prostatitis

University of Pisa

Status and phase: Unknown; Phase 3

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis; Premature Ejaculation

Treatments: Drug: Proxelan

Study type: Interventional

Funder types: Other

Identifiers

NCT03629769

1103 / 2016

Details and patient eligibility

About

The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• prostatitis like symptoms for at least three months

Exclusion criteria

• significant post-voidal residual volume
• Meares and Stamey test suggestive for bacterial infection
• neoplasms,
• urinary stones,
• antibiotic therapy in the previous three months,
• irritable bowel syndrome,
• previous radiotherapic or chemiotherapic treatment,
• urethral stenosis,
• neurogenic bladder
• previous prostatic surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with prostatitis-like symptoms

Experimental group

Description:

Cohort of patients with CP/CPPS (abacterial prostatitis)

Treatment:

Drug: Proxelan