Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194597
Status:
TERMINATED
Last Update Posted:
2008-10-22
First Post:
2005-09-13
Brief Title:
Trial of Viagra in Men With Chronic Pelvic Pain Syndrome Type III
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Trial of Viagra in Men With Chronic Pelvic Pain Syndrome Type III
Status:
TERMINATED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Illness of PI forced termination
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 subjects 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 patients first months study medication to him He will also be mailed medicationvoiding and pain diaries to fill out over the next month
1 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 months empty medication container and completed diaries will be collected A pill count will then be done
Finally the subject will receive his second months study medication and medicationvoiding and pain diaries
2 Month Visit Visit 3
Same as 1 Month Visit
3 Month Visit Visit 4
First the subject will be asked to fill out follow-up questionnaires
Next the patients caregiver will perform a physical exam and prostate massage during which expressed prostatic secretions will be collected
Then his previous months 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
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 subjects 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 patients first months study medication to him He will also be mailed medicationvoiding and pain diaries to fill out over the next month
1 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 months empty medication container and completed diaries will be collected A pill count will then be done
Finally the subject will receive his second months study medication and medicationvoiding and pain diaries
2 Month Visit Visit 3
Same as 1 Month Visit
3 Month Visit Visit 4
First the subject will be asked to fill out follow-up questionnaires
Next the patients caregiver will perform a physical exam and prostate massage during which expressed prostatic secretions will be collected
Then his previous months 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None