Status:
UNKNOWN
Repeating LiST for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome
Lead Sponsor:
Institute for the Study of Urological Diseases, Greece
Conditions:
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Eligibility:
MALE
18-60 years
Phase:
NA
Brief 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 LiS...
Eligibility Criteria
Inclusion
- 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
- 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.
- Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05366517
Start Date
September 1 2022
End Date
December 1 2023
Last Update
May 9 2022
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