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

Institute for the Study of Urological Diseases, Greece

Status: Completed

Conditions: Chronic Prostatitis

Treatments: Device: Dornier Aries 2 device

Study type: Interventional

Funder types: Other

Identifiers

NCT03543761

1340/2018

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

A

Sham Comparator group

Description:

Sham group

Treatment:

Device: Dornier Aries 2 device

Device: Dornier Aries 2 device

Device: Dornier Aries 2 device

B

Active Comparator group

Description:

LiST active treatment group

Treatment:

Device: Dornier Aries 2 device

Device: Dornier Aries 2 device

Device: Dornier Aries 2 device

C

Active Comparator group

Description:

LiST active treatment group

Treatment:

Device: Dornier Aries 2 device

Device: Dornier Aries 2 device

Device: Dornier Aries 2 device