ow-intensity Shock Wave Therapy for chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS IIIb); sham controlled, double blind, randomized prospective study
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0004441
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
1.A male over 20 years old and under 70 years old
2. Patients who have been diagnosed with chronic pelvic pain syndrome for at least 3 months or who have not been treated or who have been diagnosed and treated for chronic pelvic pain syndrome for more than 3 months
3. Patients with local pain or discomfort in the perineum or prostate area during physical examination
4. Patient whose subject or legal representative signed the subject's consent
1.Inflammatory bowel disease (Crohn's disease or ulcerative colitis, irritable bowel syndrome)
2. Patients with acute prostatitis, urinary tract infections with fever within the last 6 months (urethritis, cystitis, etc.)
3. People suffering from known malignancies over the past two years
4. Patients who have undergone surgery for urethral stenosis, enlarged prostate, or have undergone prostatectomy, TURP, TUIP, TUMT, TUNA, or prostate biopsy
5. Prostate surgery within 3 months
6.PSA> 4 ng / ml (PSA range 4-10, biopsy at PI discretion (deferral)
7. History of nervous system diseases
8. Blood clotting disorders and anticoagulants
9. Severe heart disease, heart rate imbalance and hypertension
10. Heart pacemaker wearers
11. Patients with treatment site infection or skin redness
12. Patients whose treatment area is lung, brain, spinal cord, nerve area or areas with large blood vessel distribution
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of NIH-developed Chronic Prostatitis Symptom Index(NIH-CPSI)
- Secondary Outcome Measures
Name Time Method Change of NIH-developed Chronic Prostatitis Symptom Index(NIH-CPSI);Change of visual analogue scale (VAS);Change of International Prostate Symptom Score (IPSS);Change of international index of erectile function (IIEF)