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Effects of Proxelan Somministration in Patients With Chronic Prostatitis

Primary Purpose

Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Premature Ejaculation

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Proxelan
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis focused on measuring Prostate inflammation, CPS/CPPS, Prostatitis, Proxelan

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • AOUP Ospedale cisanelloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with prostatitis-like symptoms

Arm Description

Cohort of patients with CP/CPPS (abacterial prostatitis)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2018
Last Updated
August 12, 2018
Sponsor
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT03629769
Brief Title
Effects of Proxelan Somministration in Patients With Chronic Prostatitis
Official Title
Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Premature Ejaculation
Keywords
Prostate inflammation, CPS/CPPS, Prostatitis, Proxelan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with prostatitis-like symptoms
Arm Type
Experimental
Arm Description
Cohort of patients with CP/CPPS (abacterial prostatitis)
Intervention Type
Drug
Intervention Name(s)
Proxelan
Intervention Description
Administration of one suppository of proxelan once a day for 30 days
Primary Outcome Measure Information:
Title
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score
Description
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.
Time Frame
30 days

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AOUP Ospedale cisanello
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommaso Di Vico, MD
Phone
3393642655
Email
urologiapisa@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22617307
Citation
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.
Results Reference
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Effects of Proxelan Somministration in Patients With Chronic Prostatitis

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