Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome

Study Overview
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Brief Summary
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The aim of the study is to investigate and compare the treatment efficacy and safety of ESWT vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group sham-controlled clinical study.

Official Title
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Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial

Conditions
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Chronic Prostatitis

Intervention / Treatment
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* Device: Dornier Aries 2 device
* Device: Dornier Aries 2 device
* Device: Dornier Aries 2 device


Participation Criteria
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Eligibility Criteria
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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. 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. PI-RADS score 4-5 in the baseline prostate mpMRI PI-RADS score 3, PSA>3 and age > 40 years Positive (suspicious for malignancy) DRE.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: A<br>Sham group | Device: Dornier Aries 2 device<br>* • Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.<br>|
| Active Comparator: B<br>LiST active treatment group | Device: Dornier Aries 2 device<br>* LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)<br>|
| Active Comparator: C<br>LiST active treatment group | Device: Dornier Aries 2 device<br>* LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special pain domain (items 1-4) and the score for this domain ranges from 0 to 21. | from baseline to 12 weeks after final treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9) | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome). | baseline, 4 and 12 weeks after final treatment | 
| The difference between the LiST and sham group in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special urinary symptom domain (items 5-6) and the score for this domain ranges from 0 to 10. | from baseline to 4 and 12 weeks after final treatment | 
| The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special quality of life domain (items 7-9) and the score for this domain ranges from 0 to 12. | from baseline to 4 and 12 weeks after final treatment | 
| The difference between the LiST and sham group in the change of IIEF-ED score | It will be assessed by International Index of Erectile Function -Erectile Domain (IEF-ED) score. A questionnaire designed to evaluate erectile capabilities. The questionnaire provides a score between 5 and 30.The severity categories are: 1-10 severe ED, 10-16 moderate ED, 17-21 moderate to mild ED, 22-25 mild ED, 26-30 no ED | from baseline to 4 weeks after final treatment. | 
| The difference between the LiST and sham group in the change of IPSS | They will be assessed by the International Prostate Symptom Score (IPSS). A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. Scores range from 0 to 35. The severity categories are: 1-7 mild, 8-19 moderate, 20-35 severe | from baseline to 4 weeks after final treatment. | 
| The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR) | Qmax will be measured by uroflowmetry/ PVR will be measured by ultrasound | from baseline to 4 weeks after final treatment. | 
| The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains |  | from baseline to 4 weeks after final treatment. | 
| The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS) | It will be assessed by the pain VAS, right after each LIST session. Pain VAS is a unidimensional measure of pain intensity . It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) | at week 3, 4, 5, 6, 7 and 8 | 
| Changes in mpMRI of the prostate |  | baseline and 12 weeks after treatment | 
| Adverse events rate in all patients | Potential treatment related adverse events after the first LIST session and during the 3 month follow up period will be reported | 18 weeks |