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

NCT00194597 | Terminated Phase 4

• 1 other identifier: 03-9558-D 02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatitis

Keywords

Prostatitis

Outcome Measures

Primary Outcomes (2)

• NIH-CPSI -pain scores at 3 and 12 month post tx follow-up

• AUA Score - at 3 and 12 month post tx follow-up

Secondary Outcomes (1)

• Graded Chronic Pain Scale (GCPS)-3 & 12 mo post tx f/u

Interventions

Viagra (sildenafil citrate) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of male Chronic Pelvic Pain Syndrome Type III
• Age 18 - 65
• Pelvic pain duration of at least 3 months

You may not qualify if:

• Urinary tract infection within the last year
• Sexually transmitted disease within 3 months
• Antiviral therapy or antibiotics within the last 3 months
• Currently taking any medications or recreational drugs containing nitrates 3A4 inhibitors such as erythromycin, ketoconazole, or itraconazole
• Alpha-blocker therapy for treatment of high blood pressure or prostate problems
• Suffered a heart attack, stroke or life-threatening arrhythmia within the last months
• Cardiac failure or coronary artery disease causing unstable angina
• Resting hypotension (BP\<90/50) or hypertension (BP\>170/110)
• Patients with retinitis pigmentosa
• Kidney, liver or blood problems (including sickle cell anemia or leukemia)
• Allergy to sildenafil
• Deformed penis, Peyronie's disease or ever having had an erection lasting more than 4 hours
• Stomach ulcers or any types of bleeding problems
• Use of any other medical treatments that cause erections: pills, medicines that are injected or inserted into the penis, implants or vacuum pumps
• Back pain, unilateral testicular pain or rectal pain only

Sponsors & Collaborators

• University of Washington: lead
• Berger, Richard E., M.D.: collaborator

Study Sites (1)

University of Washington, Urology Clinic

Seattle, Washington, 09195, United States

Location

MeSH Terms

Conditions

Prostatitis

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Richard E Berger, MD

  Professor of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2004
• Study Completion: July 1, 2007
• Last Updated: October 22, 2008

Record last verified: 2008-10

Locations

US (1)