Clinical trial NCT04549389: The Ideal LiST Session Frequency Protocol for CPPS Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Chronic Non-bacterial Prostatitis Type IIIB
Lead sponsor: Institute for the Study of Urological Diseases, Greece
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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
Secondary outcomes:
measure: The difference between groups in the change of total NIH-CPSI score (Q1-9)
timeFrame: Time Frame: baseline, 4 and 12 weeks after final treatment
measure: The difference between groups in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score
timeFrame: from baseline to 4 and 12 weeks after final treatment
measure: The difference between groups in the change of IIEF-ED score
timeFrame: from baseline to 4 and 12 weeks after final treatment
measure: The difference between groups in the change of IPSS
timeFrame: from baseline to 4 and 12 weeks after final treatment
measure: The difference between groups in the the Pain Visual Analogue Scale (VAS)
timeFrame: at week 3, 4, 5,
measure: Adverse events rate in all patients
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: G.Gennimatas Hospital
Study officials:
affiliation: Institute for the Study of Urological Diseases, Thessaloniki, Greece
name: Dimitrios Hatzichristou, Professor
role: PRINCIPAL_INVESTIGATOR
References: