Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- NIH-CPSI -pain scores at 3 and 12 month post tx follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of male Chronic Pelvic Pain Syndrome Type III
- •Age 18 - 65
- •Pelvic pain duration of at least 3 months
排除标准
- •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
结局指标
主要结局
NIH-CPSI -pain scores at 3 and 12 month post tx follow-up
AUA Score - at 3 and 12 month post tx follow-up
次要结局
- Graded Chronic Pain Scale (GCPS)-3 & 12 mo post tx f/u