NCT04549389

The Ideal LiST Session Frequency Protocol for CPPS Treatment

Comparing 2 Frequency Protocols of Low-intensity Shockwave Therapy for Non-bacterial Chronic Prostatitis Type IIIb /Chronic Pelvic Pain Syndrome: a Randomised Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised in 2 groups. Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week. Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week. National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED) questionnaires will be answered before and at 1 and 3 month follow up visit. Adverse events will be reported during the treatment and follow up period.

Conditions

• Chronic Pelvic Pain Syndrome
• Chronic Non-bacterial Prostatitis Type IIIB

Interventions

Type	Name	Description
DEVICE	Low intensity shockwave therapy	LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)

Timeline

• Start date: 2020-03-02
• Primary completion: 2020-10-16
• Completion: 2021-01-15
• First posted: 2020-09-16
• Last updated: 2021-02-12

Locations

1 site across 1 country: Greece