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

Institute for the Study of Urological Diseases, Greece45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Prostatitis

Interventions

Dornier Aries 2 deviceDEVICE

• 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.

Dornier Aries 2 deviceDEVICE

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)

Dornier Aries 2 deviceDEVICE

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)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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. PI-RADS score 4-5 in the baseline prostate mpMRI 11. PI-RADS score 3, PSA\>3 and age \> 40 years 12. Positive (suspicious for malignancy) DRE.

Locations (1)

G.Gennimatas Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

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.

Time frame: from baseline to 12 weeks after final treatment.

Secondary Outcomes

The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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