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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194597
Recruitment Status : Terminated (Illness of PI forced termination.)
First Posted : September 19, 2005
Last Update Posted : October 22, 2008
Berger, Richard E., M.D.
Information provided by:
University of Washington

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.

Condition or disease Intervention/treatment Phase
Prostatitis Drug: Viagra (sildenafil citrate) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III
Study Start Date : July 2004
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Primary Outcome Measures :
  1. NIH-CPSI -pain scores at 3 and 12 month post tx follow-up
  2. AUA Score - at 3 and 12 month post tx follow-up

Secondary Outcome Measures :
  1. Graded Chronic Pain Scale (GCPS)-3 & 12 mo post tx f/u

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194597

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United States, Washington
University of Washington, Urology Clinic
Seattle, Washington, United States, 09195
Sponsors and Collaborators
University of Washington
Berger, Richard E., M.D.
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Principal Investigator: Richard E Berger, MD Professor of Urology

Layout table for additonal information Identifier: NCT00194597     History of Changes
Other Study ID Numbers: 03-9558-D 02
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 22, 2008
Last Verified: October 2008
Keywords provided by University of Washington:
Additional relevant MeSH terms:
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Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents