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

This study has been terminated.
(Illness of PI forced termination.)
Sponsor:
Collaborator:
Berger, Richard E., M.D.
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194597
First received: September 13, 2005
Last updated: October 21, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Prostatitis
Drug: Viagra (sildenafil citrate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III

Resource links provided by NLM:


Further study details as provided by University of Washington:

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

Estimated Enrollment: 30
Study Start Date: July 2004
Estimated Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194597

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

No publications provided

ClinicalTrials.gov Identifier: NCT00194597     History of Changes
Other Study ID Numbers: 03-9558-D 02
Study First Received: September 13, 2005
Last Updated: October 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Prostatitis

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 09, 2014