The Ideal LiST Session Frequency Protocol for CPPS Treatment
CompletedNot applicableNCT04549389
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Comparing 2 Frequency Protocols of Low-intensity Shockwave Therapy for Non-bacterial Chronic Prostatitis Type IIIb /Chronic Pelvic Pain Syndrome: a Randomised Clinical Trial
- Conditions
- Chronic Pelvic Pain Syndrome
- Chronic Non-bacterial Prostatitis Type IIIB
- Interventions
- Device: Low intensity shockwave therapy
- Sponsor
- Institute for the Study of Urological Diseases, Greece
- Start date
- 2020-03-02
- Primary completion
- 2020-10-16
- Sex
- Male
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Greece
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Participant must 18 to 60 years of age. 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: 1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2). 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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04549389