Effects of Proxelan Somministration in Patients With Chronic Prostatitis

Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Premature Ejaculation; Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis
• Intervention / Treatment: Drug: Proxelan

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Recruiting
      • AOUP Ospedale cisanello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with prostatitis-like symptoms; Cohort of patients with CP/CPPS (abacterial prostatitis)	Drug: Proxelan; Administration of one suppository of proxelan once a day for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score	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.	30 days

Collaborators and Investigators

• Sponsor: University of Pisa

Publications and helpful links

General Publications

• Galeone G, Spadavecchia R, Balducci MT, Pagliarulo V. [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. Minerva Urol Nefrol. 2012 Jun;64(2):135-41. Italian.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Prostatitis; Prostate inflammation; CPS/CPPS; Proxelan
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Chronic Disease; Premature Ejaculation; Pelvic Pain; Prostatitis
• Other Study ID Numbers: 1103 / 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No