Effects of Proxelan Somministration in Patients With Chronic Prostatitis

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03629769
• Other study ID #: 1103 / 2016
• Status: Recruiting
• Phase: Phase 3
• Start date: February 16, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: August 2018
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Prostatitis
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Premature Ejaculation
• Prostatitis

Intervention

Drug:
• Proxelan
Administration of one suppository of proxelan once a day for 30 days

Locations

Country	Name	City	State
Italy	AOUP Ospedale cisanello	Pisa	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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