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

NCT03543761 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-03-02

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Institute for the Study of Urological Diseases, Greece

    lead OTHER

Principal Investigators

  • Dimitrios Hatzichristou, Prof. · Institute for the Study of Urological Diseases, Thessaloniki, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-09-02
Completion
2019-12-20

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543761 on ClinicalTrials.gov