Low-intensity Shock Wave Therapy for chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS IIIb); sham controlled, double blind, randomized prospective study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004441

Enrollment

Registered

2019-11-15

Start date

2019-11-11

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Treatment Group 0.25 mJ/mm2, 3Hz, 500 pulse/point: total 3000 pulse in entire prostatic and pelvic floor region, once in a week and for 8 weeks 2. Sham Group Sham Mode, 500 pulse/poin

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change of NIH-developed Chronic Prostatitis Symptom Index(NIH-CPSI)	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactKang Sup Kim

The Catholic University of Korea

qnctac@naver.com+82-32-280-5120

Outcome results