Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III

Prostatitis Clinical Trial

Official title: Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III

Status Terminated

Clinical Trial Summary

Viagra is a potent 5-PDE inhibitor that causes vasodilation in the penis and, therefore, erection in men with erectile dysfunction. Our hypothesis is that Viagra may improve the symptoms of men with Chronic Pelvic Pain Syndrome based on the following assumptions:

Chronic Pelvic Pelvic Syndrome and Interstitial Cystitis involve poorly understood central and peripheral pain sensitization such as are seen in Chronic Sympathetic Dystrophy, also called Chronic Regional Pain Syndrome. This pain may be caused by constricted blood vessels resulting from past stress, injury or trauma

Viagra will dilate sympathetically constricted vessels and improve pelvic blood flow in the same manner it does in men with erectile dysfunction.

Since men with Chronic Pelvic Pain Syndrome often complain of sexual dysfunction; improving sexual function and, therefore, quality of life may improve overall well being and perception of pain.

Clinical Trial Description

Screening Visit (Visit 1):

Patient will review and sign the study consent form. They will then be asked to complete study questionnaires regarding demographics, medical history, pelvic pain and psychological issues.

Urine will be collected and cultured for bacteria, gonorrhea and chlamydia . It will also be analyzed for white blood cells, NO and chemistry.

There will be a physical exam and prostate massage. During the prostate massage, expressed prostatic secretions will be collected and sent to the Male Fertility Lab for analysis.

Finally, he will be asked to go to the Male Fertility Lab to provide a semen sample.

Randomization:

After the subject's urine culture results have been reviewed (patient must be free of urinary tract infection to be in study), the Investigational Pharmacy will be asked to randomize the patient.

Pharmacy will then mail the patient's first month's study medication to him. He will also be mailed medication/voiding and pain diaries to fill out over the next month.

1. Month Visit (Visit 2):

The subject will return to the Urology Clinic about 1 month after his Screening Visit (Visit 1). He will first fill out follow-up forms.

Next, his previous month's empty medication container and completed diaries will be collected. A pill count will then be done

Finally, the subject will receive his second month's study medication and medication/voiding and pain diaries.

2. Month Visit (Visit 3):

Same as 1 Month Visit.

3. Month Visit (Visit 4):

First, the subject will be asked to fill out follow-up questionnaires

Next, the patient's caregiver will perform a physical exam and prostate massage during which, expressed prostatic secretions will be collected.

Then, his previous month's empty medication container and completed diaries will be collected. A pill count will then be done.

Finally, the subject will be sent to the Male Fertility Lab to collect a semen sample (as in Screening Visit).

12 Month Visit (Visit 5): With the exception of pill count, etc., same as Visit 3.

Dose:

• Active drug: Viagra, 50mg, orally, once a day, for 90 days

• Placebo: identically-appearing pill supplied by Pfizer

Concurrent Therapy:

_ No concurrent therapy will be offered ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Pain
• Prostatitis

• NCT number: NCT00194597
• Study type: Interventional
• Source: University of Washington
• Status: Terminated
• Phase: Phase 4
• Start date: July 2004
• Completion date: July 2007