Repeating LiST for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome (NCT05366517) | Clinical Trial Compass
UnknownNot Applicable
Repeating LiST for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome
50 participantsStarted 2022-09
Plain-language summary
The aim of the study is to investigate the efficacy and safety of LiST retreatment for CP/CPPS patients.A total of 50 patients with CP/CPPS diagnosis who were previously treated with 6 sessions of LiST will participate in this study.The primary study parameter is the CP/CPPS-related pain complaints and it will be assessed by the NIH-CPSI
Who can participate
Age range18 Years – 60 Years
SexMALE
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Inclusion criteria
✓. Participant must be between 18-60 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.
✓. Participant has received 6 sessions (1/week or 2/week, energy level 7, Dornier ARIES 2) of LIST the last 12 months for the treatment of CP/CPPS reporting amelioration but without complete remission of CP/CPPS symptoms ( at over 1 UPOINT positive domain).
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.
✕. Participant has undergone prostate surgery or treatment.
✕. Participant with penile or urinary sphincter implants.
What they're measuring
1
The change of the pain domain of NIH-CPSI score from baseline to 12 weeks after final treatment.
Timeframe: from baseline to 12 weeks after final treatment.
Trial details
NCT IDNCT05366517
SponsorInstitute for the Study of Urological Diseases, Greece