The Ideal LiST Session Frequency Protocol for CPPS Treatment
NCT04549389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-02-12
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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