ProstatitisPhase 4NCT00194597
Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III
A Phase 4 study testing Viagra (sildenafil citrate) in people with Prostatitis, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Prostatitis
- What is being tested?
- Viagra (sildenafil citrate)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of male Chronic Pelvic Pain Syndrome Type III
- Age 18 - 65
- Pelvic pain duration of at least 3 months
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Urology Clinic
Seattle, Washington, 09195
About this study
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
Read more
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.
Read the 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 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.
- 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.
- Month Visit (Visit 3): Same as 1 Month Visit.
- 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
- Conditions
- Prostatitis
- Being tested
- Viagra (sildenafil citrate)
- Keywords
- Prostatitis
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagra (sildenafil citrate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2004
- Study completionJul 2007
Why it stopped: Illness of PI forced termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Berger, Richard E., M.D.
- Investigators
- Richard E Berger, MD, Principal investigator, Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194597
- Sponsor's protocol ID
- 03-9558-D 02
- Status last verified
- Oct 2008
- First submitted
- 13 Sep 2005
- Last updated
- 22 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III
- ClinicalTrials.gov ID
- NCT00194597
- Acronym / sponsor ID
- 03-9558-D 02
- Conditions
- Prostatitis
- Keywords
- Prostatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Illness of PI forced termination.
- Enrolment
- 30 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Berger, Richard E., M.D.
- Study start
- Jul 2004
- Study completion
- Jul 2007
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
- 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.
- Month Visit (Visit 3): Same as 1 Month Visit.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of male Chronic Pelvic Pain Syndrome Type III
- Age 18 - 65
- Pelvic pain duration of at least 3 months
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viagra (sildenafil citrate) | Drug | – |
Primary outcome
NIH-CPSI -pain scores at 3 and 12 month post tx follow-up
AUA Score - at 3 and 12 month post tx follow-up
1 secondary outcome
Graded Chronic Pain Scale (GCPS)-3 & 12 mo post tx f/u
Results and safety
The study was stopped early (reason given: Illness of PI forced termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2008.
Related trials for Prostatitis
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Not yet recruitingPhase 3
FOsfomycin for Male Urinary Tract Infection
Urinary Tract Infection, Prostatitis
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Berger, MD principal investigator
Professor of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Viagra (sildenafil citrate) in people with Prostatitis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Illness of PI forced termination.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH-CPSI -pain scores at 3 and 12 month post tx follow-up. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2008.