The Ideal LiST Session Frequency Protocol for CPPS Treatment
NCT ID: NCT04549389
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-03-02
2021-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (1/week) by using Dornier Aries 2 shockwave machine (energy level 7)
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)
Group B
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (2/week) by using Dornier Aries 2 shockwave machine (energy level 7)
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
2. Participant has signed and dated the appropriate Informed Consent document.
3. Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months
Exclusion Criteria
2. Participant has a history of prostate, bladder or urethral cancer.
3. Participant has undergone pelvic radiation or systemic chemotherapy.
4. Participant has undergone intravesical chemotherapy.
5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.
6. Participant has undergone prostate surgery or treatment.
7. Participant with penile or urinary sphincter implants.
8. Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
10. PSA\>3 and age \> 40 years
11. Positive (suspicious for malignancy) digital rectal examination (DRE).
18 Years
60 Years
MALE
No
Sponsors
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Institute for the Study of Urological Diseases, Greece
OTHER
Responsible Party
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Dimitrios Hatzichristou
President, Institute for the Study of Urological Diseases Theesaloniki, Greece
Principal Investigators
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Dimitrios Hatzichristou, Professor
Role: PRINCIPAL_INVESTIGATOR
Institute for the Study of Urological Diseases, Thessaloniki, Greece
Locations
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G.Gennimatas Hospital
Thessaloniki, , Greece
Countries
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Other Identifiers
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1410/2020
Identifier Type: -
Identifier Source: org_study_id
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