The Ideal LiST Session Frequency Protocol for CPPS Treatment

NCT04549389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Institute for the Study of Urological Diseases, Greece

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2020-10-16
Completion
2021-01-15

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 NCT04549389 on ClinicalTrials.gov