NCT03543761

Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome

Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (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 aim of the study is to investigate and compare the treatment efficacy and safety of ESWT vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group sham-controlled clinical study.

Conditions

• Chronic Prostatitis

Interventions

Type	Name	Description
DEVICE	Dornier Aries 2 device	• Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.
DEVICE	Dornier Aries 2 device	LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)
DEVICE	Dornier Aries 2 device	LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-09-02
• Completion: 2019-12-20
• First posted: 2018-06-01
• Last updated: 2020-03-02

Locations

1 site across 1 country: Greece