The Ideal LiST Session Frequency Protocol for CPPS Treatment (NCT04549389) | Clinical Trial Compass
CompletedNot Applicable
The Ideal LiST Session Frequency Protocol for CPPS Treatment
Greece50 participantsStarted 2020-03-02
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexMALE
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Inclusion criteria
✓. Participant must 18 to 60 years of age.
✓. Participant has signed and dated the appropriate Informed Consent document.
✓. 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
✕. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
✕. Participant has a history of prostate, bladder or urethral cancer.
✕. Participant has undergone pelvic radiation or systemic chemotherapy.
✕. Participant has undergone intravesical chemotherapy.
✕. 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.
What they're measuring
1
1.The difference between groups in the change of the pain domain of NIH-CPSI score
Timeframe: from baseline to 12 weeks after final treatment
Trial details
NCT IDNCT04549389
SponsorInstitute for the Study of Urological Diseases, Greece