Effects of Proxelan Somministration in Patients With Chronic Prostatitis

Phase 3

• Conditions: Premature Ejaculation; Chronic Prostatitis; Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Interventions: Drug: Proxelan

• Registration Number: NCT03629769
• Lead Sponsor: University of Pisa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-16
• Study First Submitted: 2018-05-23
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-12
• Last Update Submitted: 2018-08-12
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with prostatitis-like symptoms	Proxelan	Cohort of patients with CP/CPPS (abacterial prostatitis)

Primary Outcome Measures

Name	Time	Method
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score	30 days	Evaluation of pain symptoms trough NIH-CPS questionnaires' pain items (0-6). Values from 0 to 3 normal/slight symptoms; Values from 3 to 6 moderate symptoms; Values over 6 severe symptoms.

Trial Locations

Locations (1)

AOUP Ospedale cisanello; 🇮🇹 Pisa, Toscana, Italy