Status:
TERMINATED
Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Berger, Richard E., M.D.
Conditions:
Prostatitis
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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 C...
Detailed 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 psych...
Eligibility Criteria
Inclusion
- Diagnosis of male Chronic Pelvic Pain Syndrome Type III
- Age 18 - 65
- Pelvic pain duration of at least 3 months
Exclusion
- 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
- Post-surgical pain
- Prostate biopsy or cystoscopy within 3 months
- Pain from another source in the genital tract, such as kidney stones or neoplasm
- History of prostate, bladder, renal or other urinary malignancies
- History of intravesical Bacillus Calmette-Guerin (BCG)
- Ulcerative colitis or Crohn's disease
- Radiation therapy to pelvis
- History of genitourinary tuberculosis
- Any neurological abnormalities including spinal cord injury and stroke
- Overtly psychotic or suicidal
- Unable to understand the protocol
- In addition, subjects will be asked to refrain from having any new treatment for prostatitis during the study period, but will be allowed to remain on stable chronic therapy that they have been receiving for 3 or more months
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00194597
Start Date
July 1 2004
End Date
July 1 2007
Last Update
October 22 2008
Active Locations (1)
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1
University of Washington, Urology Clinic
Seattle, Washington, United States, 09195